04 october 2012 ema/643088/2012 initial notices for ... · 04 october 2012 . ema/643088/2012 ......

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© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

04 October 2012 EMA/643088/2012 Patient Health Protection

Initial Notices for Parallel Distribution –2011

Product name Parallel distributor

Date of notification

Strength Pharmaceutical dosage form

Pack size EU-number Member State(s) of Origin Member State(s) of Destination

Date of Notice letter

Abilify 2 Care 4 27/06/2011 10 mg Orodispersible tablet

28 x 1 EU/1/04/276/025 Austria, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 24/08/2011

Abilify 2 Care 4 27/06/2011 15 mg Orodispersible tablet

28 x 1 EU/1/04/276/028 Austria, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 24/08/2011

Abilify Abacus Medicine A/S

28/11/2011 10 mg Tablet 56 x 1 EU/1/04/276/009 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/12/2011

Abilify Abacus Medicine A/S


Denmark 16/12/2011

Abilify ADL Pharma GmbH

18/05/2011 5 mg Tablet 14 x 1 EU/1/04/276/001 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/06/2011



Germany 01/06/2011



Germany 01/06/2011



Germany 01/06/2011



Germany 01/06/2011

Abilify Axicorp Pharma GmbH

31/03/2011 5 mg Tablet 98 x 1 EU/1/04/276/005 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 19/04/2011

Abilify Axicorp Pharma GmbH

27/09/2011 30 mg Tablet 98 x 1 EU/1/04/276/020 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/10/2011

Abilify B&S Healthcare Ltd

10/08/2011 1 mg/ml Oral solution 1 bottle + 1 cup + 1 calibrated dropper

EU/1/04/276/034 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Ireland, United Kingdom

12/08/2011

Abilify B2B Medical GmbH

06/12/2010 10 mg Tablet 49 x 1 EU/1/04/276/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/02/2011



Germany 14/02/2011

Initial Notices for Parallel Distribution –2011 EMA/643088/2012 /255



Germany 14/02/2011



Germany 14/02/2011



Germany 14/02/2011



Germany 14/02/2011



Germany 16/09/2011



Germany 26/09/2011



Germany 16/09/2011



Germany 16/09/2011



Germany 26/09/2011




Germany 26/09/2011



Germany 16/09/2011



Germany 26/09/2011



Germany 16/09/2011

Abilify BB Farma s.r.l.

04/05/2011 5 mg Tablet 49 x 1 EU/1/04/276/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 11/05/2011



Germany 25/05/2011



Germany 25/05/2011



Germany 25/05/2011



Germany 25/05/2011




Germany 09/06/2011



Germany 09/06/2011



Germany 09/06/2011

abilify Beragena Arzneimittel GmbH

30/03/2011 30 mg Tablet 98 x 1 EU/1/04/276/020 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 04/05/2011

Abilify Beragena Arzneimittel GmbH


Germany 11/05/2011



Germany 28/11/2011



Germany 28/11/2011



Germany 28/11/2011

Abilify BR Pharma International Ltd


Germany 17/02/2011



Germany 17/02/2011



Germany 21/07/2011




Germany 25/01/2011



Germany 25/01/2011



Germany 25/01/2011



Germany 25/01/2011



Germany 25/01/2011



Germany 25/01/2011



Germany 25/01/2011



Germany 25/01/2011


21/09/2010 5 mg Tablet 98 x 1 EU/1/04/276/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 25/01/2011



21/02/2011 5 mg Tablet 56 x 1 EU/1/04/276/004 Austria, Belgium, Cyprus, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/05/2011



Germany 27/05/2011



Germany 27/05/2011



Germany 27/05/2011

Abilify ChemVet Pharma ApS

17/02/2011 10 mg Tablet 28 x 1 EU/1/04/276/007 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 08/03/2011


17/02/2011 15 mg Tablet 28 x 1 EU/1/04/276/012 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 08/03/2011


04/11/2011 5 mg Tablet 28 x 1 EU/1/04/276/002 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/11/2011

Abilify Docpharm GmbH&CoKGaA

14/06/2011 10 mg Orodispersible tablet

14 x 1 EU/1/04/276/024 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/06/2011

Abilify Docpharm GmbH&CoKGaA


49 x 1 EU/1/04/276/026 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/06/2011

Abilify Emra-Med 27/09/2010 5 mg Tablet 98 x 1 EU/1/04/276/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/01/2011



Germany 04/01/2011


Germany 04/01/2011

Abilify EuroPharma DK

08/06/2011 10 mg Tablet 14 x 1 EU/1/04/276/006 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 27/06/2011



Denmark 27/06/2011



Denmark 27/06/2011



Denmark 27/06/2011



Denmark 27/06/2011



EU/1/04/276/034 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 01/08/2011

Abilify Europharma Sverige AB


28 x 1 EU/1/04/276/025 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 01/09/2011


Abilify Europharma Sverige AB


28 x 1 EU/1/04/276/028 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 01/09/2011

Abilify G-Pharma Ltd 22/03/2011 10 mg Tablet 56 x 1 EU/1/04/276/009 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Ireland, Malta, United Kingdom

31/03/2011

Abilify Interport Ltd 07/08/2011 10 mg Orodispersible tablet

28 x 1 EU/1/04/276/025 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands

United Kingdom

12/08/2011

Abilify Kohlpharma GmbH

07/04/2011 5 mg Tablet 98 x 1 EU/1/04/276/005 Austria, France, Ireland, Italy, Norway, Spain, United Kingdom

Germany 19/04/2011


07/06/2011 30 mg Tablet 98 x 1 EU/1/04/276/020 Belgium, Greece, United Kingdom Germany 13/07/2011


25/08/2011 5 mg Tablet 28 x 1 EU/1/04/276/002 Austria, France, Ireland, Italy, Spain, United Kingdom

Germany 25/08/2011

Abilify Kosei Pharma UK Limited

27/05/2011 15 mg Tablet 28 x 1 EU/1/04/276/012 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom


21/06/2011

Abilify Medartuum AB 02/11/2011 30 mg Tablet 56 x 1 EU/1/04/276/019 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 09/11/2011


Sweden 02/12/2011


Sweden 29/11/2011

Abilify MedicoPharm AG

18/03/2011 10 mg Tablet 49 x 1 EU/1/04/276/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/03/2011




Germany 28/03/2011



Germany 28/03/2011



Germany 28/03/2011



Germany 28/03/2011



49 x 1 EU/1/04/276/026 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/03/2011



49 x 1 EU/1/04/276/029 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/03/2011

Abilify Omnia Läkemedel AB

04/03/2011 30 mg Tablet 56 x 1 EU/1/04/276/019 Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Sweden 08/04/2011


07/03/2011 10 mg Tablet 56 x 1 EU/1/04/276/009 Belgium, France, Greece, Italy, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 08/04/2011


08/06/2011 15 mg Tablet 56 x 1 EU/1/04/276/014 France, Greece, Italy, Romania, Spain, The Netherlands, United Kingdom

Sweden 11/08/2011

Abilify Orifarm AS 16/11/2011 1 mg/ml Oral solution 1 bottle + 1 cup + 1 calibrated dropper


Denmark 22/11/2011

Abilify Paranova Danmark AS


Denmark 11/01/2011


Abilify Paranova Danmark AS


EU/1/04/276/034 Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/11/2011

Abilify Paranova Läkemedel AB

19/08/2011 5 mg Tablet 56 x 1 EU/1/04/276/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/08/2011


19/08/2011 5 mg Tablet 28 x 1 EU/1/04/276/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/08/2011



EU/1/04/276/034 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 19/12/2011

Abilify Pharma Westen GmbH

07/04/2011 30 mg Tablet 98 x 1 EU/1/04/276/020 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 26/04/2011

Abilify S.C. HC PHARMA STORE s.r.l.

12/09/2011 10 mg Tablet 49 x 1 EU/1/04/276/008 Romania, Spain Germany 27/10/2011

Abilify S.C. HC PHARMA STORE s.r.l.

12/09/2011 10 mg Tablet 98 x 1 EU/1/04/276/010 Romania, Spain Germany 27/10/2011

Aclasta Haemato Pharm AG

04/04/2011 5 mg/100 ml Solution for infusion

1 bottle EU/1/05/308/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 14/04/2011


Aclasta Medartuum AB 08/02/2011 5 mg/100 ml Solution for infusion

1 bottle EU/1/05/308/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 17/02/2011

Aclasta Omnia Läkemedel AB


1 bottle EU/1/05/308/001 Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Sweden 15/09/2011

Aclasta Paranova Läkemedel AB


1 bottle EU/1/05/308/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 05/04/2011

Aclasta Veron Pharma Vertriebs GmbH


1 bottle EU/1/05/308/001 Austria, Belgium, Finland, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 03/03/2011

Actos BR Pharma International Ltd

14/12/2011 45 mg Tablet 112 EU/1/00/150/029 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 22/12/2011

Actos CC Pharma 25/08/2011 30 mg Tablet 112 EU/1/00/150/027 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 31/08/2011

Actos CC Pharma 25/08/2011 30 mg Tablet 196 EU/1/00/150/028 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 31/08/2011

Actos Docpharm GmbH&CoKGaA

02/08/2011 15 mg Tablet 112 EU/1/00/150/025 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/08/2011



Germany 04/08/2011



Germany 04/08/2011



Germany 14/10/2011




Germany 25/10/2011



Germany 13/10/2011

Actos Emra-Med 11/03/2011 15 mg Tablet 112 EU/1/00/150/025 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 25/03/2011

Actos Emra-Med 20/06/2011 30 mg Tablet 112 EU/1/00/150/027 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 21/06/2011

Actos Emra-Med 27/10/2011 45 mg Tablet 112 EU/1/00/150/029 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/11/2011

Actos Eureco-Pharma B.V.

15/12/2010 30 mg Tablet 84 EU/1/00/150/020 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

31/01/2011

Actos Euro Registratie Collectief BV

08/02/2011 30 mg Tablet 84 EU/1/00/150/020 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/02/2011

Actos Kohlpharma GmbH

02/12/2011 30 mg Tablet 112 EU/1/00/150/027 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/12/2011

Actos Medartuum AB 09/12/2011 15 mg Tablet 98 EU/1/00/150/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 15/12/2011


Actos Medartuum AB 09/12/2011 45 mg Tablet 98 EU/1/00/150/015 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/12/2011

Actos MPT Pharma 24/01/2011 15 mg Tablet 196 EU/1/00/150/026 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


18/02/2011



18/02/2011



18/02/2011



18/02/2011



18/02/2011




18/02/2011



15/04/2011



15/04/2011

Actos O.P.D. Laboratories Ltd

23/07/2001 30 mg Tablet 28 EU/1/00/150/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

12/09/2011

Actos O.P.D. Laboratories Ltd

07/06/2010 45 mg Tablet 28 EU/1/00/150/012 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands


06/01/2011

Actos Pharma Westen GmbH

06/01/2011 30 mg Tablet 112 EU/1/00/150/027 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 10/01/2011


06/01/2011 45 mg Tablet 112 EU/1/00/150/029 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 10/01/2011


20/01/2011 15 mg Tablet 112 EU/1/00/150/025 Austria, Belgium, Denmark, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 25/01/2011

Actos Swingward Ltd TA Medihealth

13/09/2010 15 mg Tablet 98 EU/1/00/150/003 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands

United Kingdom

08/03/2011


Actrapid CC Pharma 27/05/2011 100 IU/ml Solution for injection

5 pre-filled pens

EU/1/02/230/008 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/06/2011

Actrapid EuroPharma DK

24/03/2011 100 IU/ml Solution for injection

5 pre-filled pens


Denmark 31/03/2011

Adcirca Haemato Pharm AG

23/05/2011 20 mg Film-coated tablet 56 EU/1/08/476/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

10/06/2011

Adcirca Haemato Pharm AG


Denmark 10/06/2011

Adrovance Euro Registratie Collectief BV

08/02/2011 70 mg/2800 IU

Tablet 4 EU/1/06/364/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

10/03/2011

Advagraf 2 Care 4 13/05/2011 3 mg Prolonged-release capsules, hard

50 EU/1/07/387/012 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 16/05/2011

Advagraf BR Pharma International Ltd

14/09/2011 3 mg Prolonged-release capsules, hard

100 x 1 EU/1/07/387/023 Belgium Germany 28/09/2011

Advagraf BR Pharma International Ltd


100 x 1 EU/1/07/387/020 Belgium Germany 29/11/2011

Advagraf CC Pharma 29/08/2011 3 mg Prolonged-release capsules, hard

100 x 1 EU/1/07/387/023 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/09/2011

Advagraf Euro Registratie Collectief BV


50 EU/1/07/387/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

03/11/2011




60 x 1 EU/1/07/387/019 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/12/2011



30 x 1 EU/1/07/387/024 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/12/2011

Advagraf Kohlpharma GmbH


100 EU/1/07/387/013 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/06/2011

Advagraf Medcor Pharmaceuticals BV


50 EU/1/07/387/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

11/04/2011

Advagraf Medcor Pharmaceuticals BV



The Netherlands

17/08/2011

Advagraf NewNeopharm BV


30 EU/1/07/387/011 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 18/05/2011

Advagraf NewNeopharm BV



Denmark 18/05/2011

Advagraf Omnia Läkemedel AB

10/05/2011 0.5 mg Prolonged-release capsules, hard

50 EU/1/07/387/002 France, Italy, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 22/06/2011




Sweden 22/06/2011



50 EU/1/07/387/012 France, Italy, Portugal, Spain, The Netherlands, United Kingdom

Sweden 22/06/2011




Sweden 22/06/2011


Advagraf Orifarm AB 21/09/2011 0.5 mg Prolonged-release capsules, hard

50 EU/1/07/387/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 03/10/2011

Advagraf Orifarm AB 21/09/2011 3 mg Prolonged-release capsules, hard

50 EU/1/07/387/012 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 03/10/2011

Advagraf Orifarm AS 11/05/2011 0.5 mg Prolonged-release capsules, hard


Denmark 27/05/2011

Advagraf Paranova Läkemedel AB


50 EU/1/07/387/012 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 09/12/2011




Sweden 09/12/2011




Sweden 09/12/2011

Aerius 2 Care 4 22/11/2010 5 mg Film-coated tablet 30 EU/1/00/160/011 Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/01/2011

Aerius 2 Care 4 22/11/2010 5 mg Film-coated tablet 100 EU/1/00/160/013 Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/01/2011


Aerius Cross Pharma AB

08/03/2011 5 mg Film-coated tablet 30 EU/1/00/160/011 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/03/2011


11/03/2011 5 mg Film-coated tablet 100 EU/1/00/160/013 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/03/2011


29/11/2011 5 mg Film-coated tablet 90 EU/1/00/160/036 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 05/12/2011

Aerius EU-Pharma BV 14/06/2011 5 mg Film-coated tablet 90 EU/1/00/160/036 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

27/06/2011

Aerius EU-Pharma BV 15/08/2011 0.5 mg/ml Oral solution 1 bottle EU/1/00/160/066 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

16/08/2011

Aerius Ichem SpZoo 08/11/2011 0.5 mg/ml Oral solution 1 bottle EU/1/00/160/069 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 21/12/2011

Aerius Medartuum AB 22/02/2011 5 mg Film-coated tablet 100 EU/1/00/160/013 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 15/03/2011


Aerius Paranova Läkemedel AB

25/11/2011 5 mg Film-coated tablet 30 EU/1/00/160/011 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 21/12/2011

Aerius Paranova Läkemedel AB


Sweden 21/12/2011

Aerius S.C. Farmastore Prest S.R.L.

04/02/2011 5 mg Film-coated tablet 10 EU/1/00/160/006 Austria, Belgium, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom

Romania 22/02/2011

Afinitor Orifarm AB 23/08/2011 10 mg Tablet 30 EU/1/09/538/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/08/2011

Aldara Cross Pharma AB

17/11/2011 5% w/w Cream 12 sachets EU/1/98/080/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 16/12/2011

Alimta AXicorp Pharma GmbH

04/10/2011 500 mg Powder for concentrate for solution for infusion

1 vial EU/1/04/290/001 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/10/2011

Alimta mibe GmbH Arzneimittel


1 vial EU/1/04/290/001 Greece Germany 16/06/2011

Alimta Orifarm OY 10/02/2011 100 mg Powder for concentrate for solution for infusion

1 vial EU/1/04/290/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 29/03/2011


Alimta Orifarm OY 16/03/2011 500 mg Powder for concentrate for solution for infusion


Finland 29/03/2011

Alimta Veron Pharma Vertriebs GmbH


1 vial EU/1/04/290/001 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 17/06/2011

alli CC Pharma 24/05/2011 60 mg Capsule, hard 120 EU/1/07/401/011 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/06/2011

Altargo Pharmachim AB

30/05/2011 1 % Ointment 1 tube EU/1/07/390/002 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Latvia, Malta, Norway, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 10/06/2011

Angiox Orifarm AB 23/05/2011 250 mg Powder for concentrate for solution for injection or infusion

10 vials EU/1/04/289/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/05/2011

Apidra Axicorp Pharma GmbH

18/08/2011 100 Units/ml Solution for injection

5 cartridges EU/1/04/285/008 Austria, Belgium, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/09/2011

Apidra Axicorp Pharma GmbH


10 cartridges

EU/1/04/285/012 Austria, Belgium, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/09/2011

Apidra CC Pharma 26/11/2010 100 Units/ml Solution for injection

5 cartridges EU/1/04/285/008 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/01/2011


10 cartridges

EU/1/04/285/012 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/01/2011


5 pre-filled pens


Germany 16/11/2011



10 pre-filled pens


Germany 11/11/2011

Apidra Dr Fisher Farma BV


5 pre-filled pens

EU/1/04/285/016 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

15/06/2011

Apidra Emra-Med 19/01/2010 100 Units/ml Solution for injection

5 vials EU/1/04/285/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/03/2011

Apidra Eureco-Pharma B.V.


5 cartridges EU/1/04/285/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/02/2011

Apidra Euro Registratie Collectief BV


5 cartridges EU/1/04/285/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

27/06/2011

Apidra Kohlpharma GmbH


5 pre-filled pens

EU/1/04/285/032 Austria, Belgium, France, Greece, Italy, Norway, United Kingdom

Germany 25/01/2011



5 pre-filled pens

EU/1/04/285/016 Austria, Greece, Italy Germany 25/01/2011



10 pre-filled pens

EU/1/04/285/020 Austria, Greece, Italy Germany 25/01/2011



5 cartridges EU/1/04/285/008 Austria, France, Greece, Italy, Romania Germany 25/01/2011



10 cartridges

EU/1/04/285/012 Austria, France, Greece, Italy, Romania Germany 25/01/2011

Apidra Orifarm AB 02/02/2011 100 Units/ml Solution for injection

5 pre-filled pens

EU/1/04/285/032 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 03/03/2011


Apidra (SoloStar) Beragena Arzneimittel GmbH


10 pre-filled pens

EU/1/04/285/036 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 10/05/2011

Apidra (SoloStar) Beragena Arzneimittel GmbH


5 pre-filled pens


Germany 10/05/2011

Apidra Optiset Emra-Med 10/12/2010 100 Units/ml Solution for injection

5 pre-filled pens

EU/1/04/285/016 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 25/02/2011

Apidra Optiset Emra-Med 10/12/2010 100 Units/ml Solution for injection

10 pre-filled pens


Germany 25/02/2011

Apidra SoloStar Axicorp Pharma GmbH


5 pre-filled pens

EU/1/04/285/032 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/09/2011

Apidra SoloStar Axicorp Pharma GmbH


10 pre-filled pens

EU/1/04/285/036 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/09/2011

Apidra Solostar CC Pharma 26/11/2010 100 Units/ml Solution for injection

5 pre-filled pens


Germany 13/01/2011

Apidra Solostar CC Pharma 07/12/2010 100 Units/ml Solution for injection

10 pre-filled pens


Germany 13/01/2011

Apidra Solostar Kohlpharma GmbH


10 pre-filled pens

EU/1/04/285/036 Austria, Belgium, France, Greece, Italy, Norway, United Kingdom

Germany 25/01/2011

Aprovel CC Pharma 21/12/2010 75 mg Film-coated tablet 28 EU/1/97/046/017 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/01/2011


Germany 13/01/2011



Germany 13/01/2011

Aprovel CC Pharma 17/02/2011 300 mg Film-coated tablet 56 EU/1/97/046/028 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 24/03/2011

Aprovel EU-Pharma BV 03/05/2011 150 mg Film-coated tablet 28 EU/1/97/046/022 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

10/05/2011

Aprovel EU-Pharma BV 17/05/2011 150 mg Tablet 28 EU/1/97/046/004 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

18/05/2011

Aranesp Axicorp Pharma GmbH

22/07/2011 500 µg Solution for injection

1 pre-filled syringe with needle guard

EU/1/01/185/098 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/09/2011

Aranesp Beragena Arzneimittel GmbH


4 pre-filled syringes


Germany 26/04/2011





Germany 19/04/2011





Germany 26/04/2011



1 pre-filled syringe


Germany 26/04/2011



4 pre-filled syringes with needle guard


Germany 27/04/2011





Germany 27/04/2011





Germany 08/07/2011






Germany 08/07/2011





Germany 28/09/2011





Germany 28/09/2011





Germany 28/09/2011





Germany 28/09/2011





Germany 04/11/2011





Germany 04/11/2011





Germany 04/11/2011





Germany 04/11/2011





Germany 14/11/2011

Aranesp CC Pharma 04/01/2011 15 µg Solution for injection

4 pre-filled syringes with needle guards


Germany 18/01/2011



EU/1/01/185/085 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/04/2011





Germany 17/05/2011




Germany 10/06/2011




Germany 10/06/2011




Germany 10/06/2011

Aranesp Emra-Med 04/11/2010 300 µg Solution for injection

1 pre-filled syringe (non-blister)


Germany 10/02/2011


1 pre-filled syringe (non-blister)


Germany 10/02/2011




Germany 04/02/2011




Germany 09/02/2011




Germany 04/02/2011




Germany 09/02/2011


Aranesp Euro Registratie Collectief BV



EU/1/01/185/078 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

14/06/2011

Aranesp Haemato Pharm AG



EU/1/01/185/018 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 14/04/2011





Denmark 14/04/2011





Denmark 14/04/2011





Denmark 14/04/2011





Denmark 14/04/2011





Denmark 12/05/2011






Denmark 12/05/2011





Denmark 12/05/2011





Denmark 12/05/2011





Denmark 12/05/2011





Denmark 12/05/2011





Denmark 12/05/2011






Denmark 12/05/2011





Denmark 12/05/2011





Denmark 20/06/2011





Denmark 20/06/2011





Denmark 21/06/2011

Aranesp Medcor Pharmaceuticals BV




The Netherlands

15/03/2011





The Netherlands

04/07/2011






The Netherlands

23/08/2011





The Netherlands

23/08/2011





The Netherlands

23/08/2011





The Netherlands

23/08/2011





The Netherlands

23/08/2011





The Netherlands

07/09/2011

Aranesp Orifarm AS 16/03/2011 150 µg Solution for injection

1 pre-filled pen


Denmark 20/04/2011


1 pre-filled pen

EU/1/01/185/047 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/07/2011



1 pre-filled pen

EU/1/01/185/049 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/07/2011

Aranesp Paranova Läkemedel AB




Sweden 23/11/2011

Aranesp Pharma Westen GmbH




Germany 11/11/2011

Aranesp (SureClick)

Paranova OY 30/08/2011 500 µg Solution for injection

1 pre-filled pen

EU/1/01/185/056 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 04/10/2011

Arava ADL Pharma GmbH

31/01/2011 10 mg Film-coated tablet 30 EU/1/99/118/003 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 19/04/2011



Germany 25/07/2011


30/06/2011 20 mg Film-coated tablet 30 EU/1/99/118/007 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 13/07/2011


30/06/2011 20 mg Film-coated tablet 100 EU/1/99/118/008 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 13/07/2011


Arava BB Farma s.r.l.

18/08/2011 10 mg Film-coated tablet 30 EU/1/99/118/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/09/2011

Arava BB Farma s.r.l.


Germany 06/09/2011

Arava CC Pharma 18/07/2011 10 mg Film-coated tablet 30 EU/1/99/118/003 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Lithuania, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 23/08/2011

Arava Haemato Pharm AG

15/04/2011 10 mg Film-coated tablet 100 EU/1/99/118/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 20/04/2011

Arava Haemato Pharm AG


Denmark 02/05/2011

Arava MPT Pharma 16/11/2010 10 mg Film-coated tablet 30 EU/1/99/118/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


26/01/2011

Arava MPT Pharma 16/11/2010 10 mg Film-coated tablet 100 EU/1/99/118/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


26/01/2011


Arava MPT Pharma 14/03/2011 20 mg Film-coated tablet 30 EU/1/99/118/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom


31/03/2011

Arava Propharmed GmbH

24/02/2011 20 mg Film-coated tablet 100 EU/1/99/118/008 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 02/03/2011

Arixtra 2 Care 4 22/06/2011 1.5 mg/0.3 ml Solution for injection


EU/1/02/206/006 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/08/2011

Arixtra 2 Care 4 22/06/2011 10 mg/0.8 ml Solution for injection



Denmark 10/08/2011




Denmark 10/08/2011

Arixtra 2 Care 4 22/06/2011 5 mg/0.4 ml Solution for injection



Denmark 10/08/2011




Denmark 10/08/2011

Arixtra Axicorp Pharma GmbH

15/03/2011 2.5 mg/0.5 ml Solution for injection



Germany 29/03/2011

Arixtra Elpis Ltd. 22/12/2009 2.5 mg/0.5 ml Solution for injection


EU/1/02/206/002 Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Latvia 11/03/2011

Arixtra Emra-Med 03/01/2011 1.5 mg/0.3 ml Solution for injection



Germany 14/01/2011


Arixtra Orifarm AS 03/01/2011 7.5 mg/0.6 ml Solution for injection



Denmark 03/03/2011

Arixtra Orifarm AS 03/08/2011 1.5 mg/0.3 ml Solution for injection



Denmark 09/08/2011

Arixtra Orifarm AS 03/08/2011 10 mg/0.8 ml Solution for injection



Denmark 09/08/2011

Arixtra Orifarm AS 03/08/2011 5 mg/0.4 ml Solution for injection



Denmark 09/08/2011

atriance Haemato Pharm AG

04/04/2011 5 mg/ml Solution for infusion

6 vials EU/1/07/403/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/04/2011

Atripla Delphi Pharmaceuticals BV

23/02/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, United Kingdom

The Netherlands

27/04/2011

Atripla EU-Pharma BV 26/04/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

03/05/2011


Atripla Haemato Pharm AG

21/04/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 29/04/2011

Atripla Medartuum AB 10/05/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 16/05/2011

Atripla NewNeopharm BV

28/10/2010 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 07/01/2011

Atripla Orifarm AB 03/08/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 22/08/2011

Atripla Orifarm OY 15/03/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 28/03/2011

Atripla Paranova Läkemedel AB

29/08/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 15/11/2011

Atripla Paranova OY 10/03/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 14/04/2011


Atripla Pharmachim AB

23/11/2011 -- Film-coated tablet 30 EU/1/07/430/001 Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Malta, Norway, Poland, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 29/11/2011

Avamys Clear Pharmacy

15/07/2011 27.5 micrograms/ spray

Nasal spray, suspension

1 bottle EU/1/07/434/003 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Malta, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom


21/07/2011

Avamys EU-Pharma BV 14/07/2011 27.5 micrograms/ spray


1 bottle EU/1/07/434/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

20/07/2011

Avamys Imed Healthcare Ltd



1 bottle EU/1/07/434/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


12/08/2011

Avamys Mediwin Ltd 20/06/2011 27.5 micrograms/ spray


1 bottle EU/1/07/434/003 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Sweden, The Netherlands, United Kingdom

Spain 19/07/2011

Avamys Mediwin Ltd 20/06/2011 27.5 micrograms/ spray


1 bottle EU/1/07/434/003 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Italy 19/07/2011

Avamys PCO Manufacturing



1 bottle EU/1/07/434/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


12/01/2011

Avamys Pharmachim AB



1 bottle EU/1/07/434/003 Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 17/10/2011

Avandamet Emra-Med 16/04/2010 4 mg/1000 mg Film-coated tablet 56 EU/1/03/258/012 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/01/2011


Avandia Cross Pharma AB

04/05/2010 4 mg Film-coated tablet 28 EU/1/00/137/006 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Sweden 12/01/2011

Avastin Dr Fisher Farma BV

08/02/2011 25 mg/ml Concentrate for solution for infusion

1 vial EU/1/04/300/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/03/2011

Avastin Orifarm AB 31/03/2011 25 mg/ml Concentrate for solution for infusion

1 vial EU/1/04/300/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 06/04/2011

Avastin Orifarm AB 31/03/2011 25 mg/ml Concentrate for solution for infusion


Sweden 06/04/2011

Avastin Orifarm OY 17/02/2011 25 mg/ml Concentrate for solution for infusion


Finland 07/03/2011

Avastin Orifarm OY 17/02/2011 25 mg/ml Concentrate for solution for infusion


Finland 07/03/2011

Avonex CC Pharma 14/10/2011 30 µg/0.5 ml (6 million IU)

Solution for injection

4 pre-filled pens

EU/1/97/033/005 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/12/2011


Avonex Emra-Med 05/09/2011 30 µg/0.5 ml (6 million IU)


12 pre-filled syringes + 12 needles

EU/1/97/033/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/09/2011

Avonex Inopha GmbH 22/03/2011 30 µg/0.5 ml (6 million IU)



EU/1/97/033/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

28/03/2011

Avonex Pharma Westen GmbH

15/11/2011 30 µg/0.5 ml (6 million IU)


4 pre-filled pens


Germany 12/12/2011

Avonex Veron Pharma Vertriebs GmbH

13/12/2010 30 µg/0.5 ml (6 million IU)



EU/1/97/033/003 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 09/02/2011

Axura 2 Care 4 30/11/2011 10 mg Film-coated tablet 28 EU/1/02/218/007 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/12/2011


Denmark 16/12/2011


Denmark 21/12/2011


Denmark 21/12/2011

Axura CC Pharma 04/07/2011 5 mg + 10 mg + 15 mg + 20 mg

Film-coated tablet 7 x 5 mg + 7 x 10 mg +7 x 15 mg +7 x 20 mg


Germany 08/09/2011

Axura Ethigen Limited

04/10/2011 10 mg Film-coated tablet 28 EU/1/02/218/007 Germany United Kingdom

27/10/2011


Axura Omnia Läkemedel AB

11/08/2011 10 mg Film-coated tablet 98 EU/1/02/218/014 Bulgaria, Germany, Portugal Sweden 16/08/2011

Axura Pharma Westen GmbH

21/04/2011 10 mg Film-coated tablet 98 EU/1/02/218/014 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/04/2011

Azarga B&S Healthcare Ltd

15/11/2011 10 mg/ml / 5 mg/ml

Eye drops, suspension

1 bottle EU/1/08/482/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


02/12/2011

Azarga CC Pharma 07/12/2010 10 mg/ml / 5 mg/ml


1 bottle EU/1/08/482/001 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/01/2011

Azarga CC Pharma 07/12/2010 10 mg/ml / 5 mg/ml


3 bottles EU/1/08/482/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/01/2011

Azarga Mevita HandelsGmbH

02/12/2011 10 mg/ml / 5 mg/ml


1 bottle EU/1/08/482/001 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 14/12/2011

Azarga Mevita HandelsGmbH

02/12/2011 10 mg/ml / 5 mg/ml


3 bottles EU/1/08/482/002 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 14/12/2011

Azarga Orifarm AB 12/10/2011 10 mg/ml / 5 mg/ml


3 bottles EU/1/08/482/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 22/11/2011

Azarga Paranova Läkemedel AB

02/12/2011 10 mg/ml / 5 mg/ml


1 bottle EU/1/08/482/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 21/12/2011


Azarga Paranova Läkemedel AB

02/12/2011 10 mg/ml / 5 mg/ml


3 bottles EU/1/08/482/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 21/12/2011

Azarga Swingward Ltd TA Medihealth

26/08/2009 10 mg/ml / 5 mg/ml


1 bottle EU/1/08/482/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

06/01/2011

Azilect Abacus Medicine A/S

20/04/2011 1 mg Tablet 112 EU/1/04/304/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 27/04/2011

Azilect Abacus Medicine A/S

20/04/2011 1 mg Tablet 28 EU/1/04/304/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 27/04/2011

AZILECT BR Pharma International Ltd

04/04/2011 1 mg Tablet 28 EU/1/04/304/003 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands


13/04/2011

AZILECT Clear Pharmacy

31/03/2011 1 mg Tablet 28 EU/1/04/304/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom


07/04/2011

AZILECT Dr Fisher Farma BV


The Netherlands

20/07/2011

AZILECT EuroPharma DK

13/01/2011 1 mg Tablet 28 EU/1/04/304/003 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 17/01/2011


AZILECT EuroPharma DK

13/01/2011 1 mg Tablet 112 EU/1/04/304/006 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 17/01/2011

AZILECT Interport Ltd 29/07/2011 1 mg Tablet 28 EU/1/04/304/003 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands

United Kingdom

12/08/2011

AZILECT Omnia Läkemedel AB

09/08/2011 1 mg Tablet 112 EU/1/04/304/006 Belgium, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Spain, United Kingdom

Sweden 15/08/2011

AZILECT Orifarm AS 11/05/2011 1 mg Tablet 30 EU/1/04/304/004 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 13/05/2011

AZILECT Paranova Danmark AS

09/03/2011 1 mg Tablet 112 EU/1/04/304/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/05/2011

Azopt Medartuum AB 31/03/2011 10 mg/ml Eye drops, suspension

3 bottles EU/1/00/129/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 13/04/2011

Azopt Mevita HandelsGmbH

07/10/2011 10 mg/ml Eye drops, suspension

1 bottle EU/1/00/129/001 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 26/10/2011

Azopt Mevita HandelsGmbH


3 bottles EU/1/00/129/003 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 26/10/2011

Baraclude CC Pharma 22/03/2011 0.05 mg/ml Oral solution 1 bottle + 1 measuring spoon


Germany 15/04/2011

Baraclude Combiphar Europe BV

08/10/2009 0.5 mg Film-coated tablet 30 x 1 EU/1/06/343/003 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

12/09/2011


Baraclude Haemato Pharm AG

15/04/2011 0.5 mg Film-coated tablet 30 x 1 EU/1/06/343/003 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 20/04/2011

Baraclude Omnia Läkemedel AB

16/09/2011 0.5 mg Film-coated tablet 30 x 1 EU/1/06/343/003 Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 26/09/2011

Baraclude Paranova Läkemedel AB

21/06/2011 0.5 mg Film-coated tablet 30 x 1 EU/1/06/343/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 25/07/2011

Benlysta Emra-Med 18/11/2011 120 mg Powder for concentrate for solution for infusion

1 vial EU/1/11/700/001 Austria, Belgium, Ireland, Malta, The Netherlands, United Kingdom

Germany 21/12/2011

Benlysta Emra-Med 18/11/2011 400 mg Powder for concentrate for solution for infusion

1 vial EU/1/11/700/002 Austria, Belgium, Ireland, Malta, The Netherlands, United Kingdom

Germany 21/12/2011

Benlysta Haemato Pharm AG


1 vial EU/1/11/700/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/09/2011

Benlysta Haemato Pharm AG



Germany 29/09/2011

Betaferon Axicorp Pharma B.V.

23/08/2011 0.25 mg/ml Powder and solvent for solution for injection

3 x 14 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)

EU/1/95/003/010 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 02/09/2011





EU/1/95/003/007 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/09/2011



14 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)

EU/1/95/003/009 Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Germany 16/12/2011

Betaferon Emra-Med 04/01/2010 0.25 mg/ml Powder and solvent for solution for injection


EU/1/95/003/010 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/05/2011

Betaferon EVE Packs GmbH




Germany 27/05/2011

Betaferon Haemato Pharm AG




Denmark 13/04/2011


Betaferon Medartuum AB 13/07/2011 0.25 mg/ml Powder and solvent for solution for injection



Sweden 15/09/2011

Betaferon Omnia Läkemedel AB



EU/1/95/003/005 Belgium, Bulgaria, France, Greece, Italy, Lithuania, Poland, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 08/09/2011

Betaferon Orifarm AB 17/05/2011 0.25 mg/ml Powder and solvent for solution for injection



Sweden 11/07/2011

Betaferon Orifarm OY 13/09/2011 0.25 mg/ml Powder and solvent for solution for injection


EU/1/95/003/005 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 20/10/2011

Betaferon Paranova OY 25/08/2011 0.25 mg/ml Powder and solvent for solutionfor injection



Finland 11/11/2011


Betaferon Pharma Westen GmbH



EU/1/95/003/009 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/12/2011




EU/1/95/003/010 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/12/2011





Germany 16/12/2011

Betaferon Pharmachim AB



EU/1/95/003/005 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 13/12/2011

Bondronat Kohlpharma GmbH

18/10/2011 6 mg/6 ml Concentrate for solution for infusion

5 vials EU/1/96/012/012 Czech Republic, Greece, Romania Germany 03/11/2011

Bonviva Abacus Medicine A/S

03/03/2011 150 mg Film-coated tablet 1 EU/1/03/265/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 08/03/2011


Bonviva MPT Pharma 26/07/2011 150 mg Film-coated tablet 1 EU/1/03/265/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


03/08/2011

Bonviva MPT Pharma 26/07/2011 150 mg Film-coated tablet 3 EU/1/03/265/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


03/08/2011

Bridion Orifarm AB 12/05/2011 100 mg/ml Solution for injection


Sweden 18/05/2011

Brilique CC Pharma 24/05/2011 90 mg Film-coated tablet 56 EU/1/10/655/004 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/06/2011

Brilique CC Pharma 24/05/2011 90 mg Film-coated tablet 100 x 1 EU/1/10/655/006 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/06/2011

Brilique Doncaster Pharmaceuticals Group Ltd

30/08/2011 90 mg Film-coated tablet 56 EU/1/10/655/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


14/09/2011

BYETTA CC Pharma 30/09/2010 10 micrograms


1 pre-filled pen

EU/1/06/362/003 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 18/05/2011

BYETTA Orifarm AB 07/04/2011 10 micrograms


1 pre-filled pen


Sweden 19/04/2011

BYETTA PCO Manufacturing

18/03/2011 5 micrograms Solution for injection

1 pre-filled pen

EU/1/06/362/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


10/06/2011

Caelyx Euro Registratie Collectief BV

24/02/2011 2.0 mg/ml Concentrate for solution for infusion

1 vial EU/1/96/011/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

03/03/2011


Caelyx Euro Registratie Collectief BV


1 vial EU/1/96/011/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

03/03/2011

Caelyx Inopha GmbH 16/03/2011 2.0 mg/ml Concentrate for solution for infusion

1 vial EU/1/96/011/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

23/03/2011

Caelyx Inopha GmbH 16/03/2011 2.0 mg/ml Concentrate for solution for infusion

1 vial EU/1/96/011/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

23/03/2011

Caelyx InPharm Spzoo


1 vial EU/1/96/011/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 04/10/2011

Caelyx Orifarm AB 29/11/2010 2.0 mg/ml Concentrate for solution for infusion

1 vial EU/1/96/011/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 19/01/2011

Caelyx Pharmachim AB


1 vial EU/1/96/011/001 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 28/03/2011

Caelyx Pharmachim AB



Sweden 28/03/2011

Cancidas Emra-Med 15/03/2011 50 mg Powder for concentrate for solution for infusion

1 vial EU/1/01/196/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 31/03/2011


Cancidas Haemato Pharm AG


1 vial EU/1/01/196/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/05/2011

Cancidas Haemato Pharm AG


1 vial EU/1/01/196/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/05/2011

Cancidas InPharm Spzoo



Poland 15/09/2011

Cancidas InPharm Spzoo



Poland 15/09/2011

Cancidas Paranova Läkemedel AB



Sweden 17/05/2011

Cancidas Paranova Läkemedel AB



Sweden 17/05/2011


Cancidas Pharmachim AB


1 vial EU/1/01/196/001 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 21/02/2011

Cancidas Pharmachim AB


1 vial EU/1/01/196/003 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 21/02/2011

CellCept BB Farma s.r.l.

05/10/2011 250 mg Capsule, hard 300 EU/1/96/005/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/11/2011



Germany 07/11/2011



Germany 10/11/2011



Germany 07/11/2011

CellCept EU-Pharma BV 07/12/2011 500 mg Film-coated tablet 150 EU/1/96/005/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

19/12/2011


CellCept EuroPharma DK

16/02/2011 250 mg Capsule, hard 100 EU/1/96/005/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 04/03/2011

CellCept EuroPharma DK

16/02/2011 250 mg Capsule, hard 300 EU/1/96/005/003 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 31/03/2011

CellCept Europharma Sverige AB

06/07/2011 250 mg Capsule, hard 100 EU/1/96/005/001 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Poland, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 18/07/2011

CellCept Europharma Sverige AB

06/07/2011 500 mg Film-coated tablet 50 EU/1/96/005/002 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Norway, Poland, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 18/07/2011

CellCept Haemato Pharm AG


Denmark 18/05/2011

CellCept MPT Pharma 04/01/2011 500 mg Film-coated tablet 50 EU/1/96/005/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


13/01/2011

CellCept MPT Pharma 04/01/2011 500 mg Film-coated tablet 150 EU/1/96/005/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


13/01/2011


Cellcept MPT Pharma 10/06/2011 250 mg Capsule, hard 100 EU/1/96/005/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


28/06/2011

CellCept Orifarm AS 27/09/2011 1 g/5 ml Powder for oral suspension

1 bottle EU/1/96/005/006 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/10/2011

Celsentri Haemato Pharm AG


Denmark 13/04/2011

Celsentri Haemato Pharm AG


Denmark 13/04/2011

Celsentri MedicoPharm AG

03/08/2011 150 mg Film-coated tablet 60 EU/1/07/418/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 10/08/2011

Celsentri MedicoPharm AG


Germany 10/08/2011

Celsentri Orifarm AS 23/11/2011 150 mg Film-coated tablet 60 EU/1/07/418/003 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 23/11/2011

Celsentri Orifarm AS 23/11/2011 300 mg Film-coated tablet 60 EU/1/07/418/008 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 23/11/2011


Celsentri Paranova Danmark AS

28/10/2011 300 mg Film-coated tablet 60 EU/1/07/418/008 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 05/12/2011

Cerezyme Medartuum AB 20/06/2011 400 U Powder for concentrate for solution for infusion


Sweden 30/06/2011

Cervarix Axicorp Pharma GmbH

20/06/2011 - - Suspension for injection

1 pre-filled syringe + 1 needle

EU/1/07/419/004 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/07/2011

Cervarix CC Pharma 18/05/2011 - - Suspension for injection


EU/1/07/419/004 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 22/06/2011

Cetrotide Axicorp Pharma GmbH

17/08/2011 0.25 mg Powder and solvent for solution for injection

1 vial + 1 pre-filled syringe + 2 injection needles + 2 alcohol swabs


Germany 26/08/2011

Cetrotide CC Pharma 15/03/2011 0.25 mg Powder and solvent for solution for injection

7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs


Germany 14/04/2011

Cetrotide CC Pharma 15/03/2011 3 mg Powder and solvent for solution for injection



Germany 14/04/2011


Cetrotide Dr Fisher Farma BV

22/09/2010 0.25 mg Powder and solvent for solution for injection



The Netherlands

25/02/2011

Cetrotide Emra-Med 18/07/2011 0.25 mg Powder and solvent for solution for injection

7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs

EU/1/99/100/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/09/2011

Cetrotide Emra-Med 18/07/2011 3 mg Powder and solvent for solution for injection



Germany 06/09/2011

Champix EU-Pharma BV 06/09/2011 1.0 mg Film-coated tablet 28 EU/1/06/360/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

14/09/2011

Champix Imed Healthcare Ltd

07/07/2011 1.0 mg Film-coated tablet 56 EU/1/06/360/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


28/07/2011

Champix Omnia Läkemedel AB

08/06/2011 1.0 mg Film-coated tablet 112 EU/1/06/360/011 Belgium, France, Greece, Italy, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 02/08/2011

Champix Paranova Danmark AS

10/05/2011 1.0 mg Film-coated tablet 56 EU/1/06/360/005 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 18/07/2011

Cholestagel CC Pharma 15/03/2010 625 mg Film-coated tablet 180 EU/1/03/268/004 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/12/2011


Cialis 2 Care 4 22/07/2010 5 mg Film-coated tablet 28 EU/1/02/237/008 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 21/02/2011

Cialis Abacus Medicine A/S

27/09/2011 10 mg Film-coated tablet 4 EU/1/02/237/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 26/10/2011

Cialis Abacus Medicine A/S

27/09/2011 5 mg Film-coated tablet 28 EU/1/02/237/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/10/2011

Cialis ABACUS MEDICINE A/S

19/12/2011 20 mg Film-coated tablet 4 EU/1/02/237/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/12/2011

Cialis Beragena Arzneimittel GmbH

06/09/2011 5 mg Film-coated tablet 28 EU/1/02/237/008 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 28/09/2011

Cialis CC Pharma 08/02/2011 10 mg Film-coated tablet 4 EU/1/02/237/001 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/03/2011

Cialis CC Pharma 08/11/2011 20 mg Film-coated tablet 12 EU/1/02/237/005 Austria, Belgium, Bulgaria, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 02/12/2011

Cialis ChemVet Pharma ApS

07/04/2011 20 mg Film-coated tablet 4 EU/1/02/237/003 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/05/2011

Cialis ChemVet Pharma ApS

07/04/2011 5 mg Film-coated tablet 28 EU/1/02/237/008 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/05/2011

Cialis Docpharm GmbH&CoKGaA


Germany 28/01/2011


Cialis Emra-Med 25/11/2011 5 mg Film-coated tablet 14 EU/1/02/237/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/12/2011

Cialis Euro Registratie Collectief BV

20/06/2011 5 mg Film-coated tablet 28 EU/1/02/237/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

27/06/2011

Cialis EuroPharma DK

14/01/2011 10 mg Film-coated tablet 4 EU/1/02/237/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 08/02/2011

Cialis Kohlpharma GmbH

21/11/2011 5 mg Film-coated tablet 14 EU/1/02/237/007 France, The Netherlands, United Kingdom Germany 30/11/2011

Cialis MedicoPharm AG


Germany 18/02/2011

Cialis Mevita HandelsGmbH

08/11/2010 20 mg Film-coated tablet 8 EU/1/02/237/004 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 07/06/2011

Cialis Mevita HandelsGmbH


Germany 07/06/2011

Cialis Singad Pharma ApS

03/08/2011 5 mg Film-coated tablet 28 EU/1/02/237/008 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 15/08/2011

Cialis Singad Pharma ApS

04/08/2011 10 mg Film-coated tablet 4 EU/1/02/237/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/08/2011

Cimzia Axicorp Pharma GmbH

26/10/2011 200 mg Solution for injection

2 pre-filled syringes + 2 alcohol swabs

EU/1/09/544/001 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 21/11/2011

Cimzia CC Pharma 13/04/2011 200 mg Solution for injection

6 (3 x 2) pre-filled syringes + 6 (3 x 2) alcohol swabs


Germany 20/04/2011


Cimzia Dr Fisher Farma BV




The Netherlands

20/09/2011

Cimzia Euro Registratie Collectief BV




The Netherlands

10/05/2011

Cimzia Kohlpharma GmbH



EU/1/09/544/002 Austria, Belgium, France, Sweden, United Kingdom

Germany 05/09/2011

Cimzia Orifarm AB 12/10/2011 200 mg Solution for injection



Sweden 25/10/2011

Cimzia Orifarm AS 06/05/2011 200 mg Solution for injection



Denmark 25/05/2011

Cimzia Pharma Westen GmbH



EU/1/09/544/001 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 02/02/2011

Cimzia Pharma Westen GmbH




Germany 03/02/2011

Circadin Dr Fisher Farma BV

26/09/2011 2 mg Prolonged-release tablet


The Netherlands

12/10/2011

Circadin Euro Registratie Collectief BV



The Netherlands

09/03/2011


circadin Ginova Ltd 18/04/2011 2 mg Prolonged-release tablet

21 EU/1/07/392/001 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands


20/04/2011

Circadin Pharmachim AB


21 EU/1/07/392/001 Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 08/09/2011

Clopidogrel Mylan Euromedicines, S.L.

12/07/2010 75 mg Film-coated tablet 28 EU/1/09/559/014 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, The Netherlands, United Kingdom

Spain 15/03/2011

Clopidogrel Teva Delfarma SpZoo

25/10/2011 75 mg Film-coated tablet 28 x 1 EU/1/09/540/011 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 08/12/2011

CoAprovel B&S Healthcare

05/09/2011 300 mg/ 25 mg

Film-coated tablet 28 EU/1/98/086/024 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


04/10/2011

CoAprovel CC Pharma 04/11/2011 150 mg/ 12.50 mg

Film-coated tablet 56 x 1 EU/1/98/086/014 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/12/2011

CoAprovel Chemilines Ltd 18/10/2011 300 mg/ 25 mg

Film-coated tablet 28 EU/1/98/086/024 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands

United Kingdom

15/11/2011

CoAprovel Dr Fisher Farma BV

05/07/2011 300 mg/ 25 mg

Film-coated tablet 28 EU/1/98/086/024 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

14/07/2011

CoAprovel Emra-Med 11/07/2011 300 mg/ 12.50 mg

Film-coated tablet 28 EU/1/98/086/017 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 25/08/2011




Germany 25/08/2011



Germany 25/08/2011

CoAprovel EU-Pharma BV 20/07/2011 150 mg/ 12.50 mg

Tablet 28 EU/1/98/086/001 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

26/07/2011

CoAprovel EU-Pharma BV 27/07/2011 150 mg/ 12.50 mg

Film-coated tablet 28 EU/1/98/086/012 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

08/08/2011

CoAprovel Orifarm AB 12/05/2011 300 mg/ 25 mg

Film-coated tablet 98 EU/1/98/086/027 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 19/05/2011

Combivir Docpharm GmbH&CoKGaA

26/01/2011 150 mg/ 300 mg

Film-coated tablet 60 EU/1/98/058/001 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/02/2011

Combivir Medartuum AB 27/09/2011 150 mg/ 300 mg

Film-coated tablet 60 EU/1/98/058/001 Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 03/10/2011

Competact Chemilines Ltd 20/06/2011 15 mg/ 850 mg

Film-coated tablet 60 EU/1/06/354/006 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands

United Kingdom

13/09/2011

Competact Docpharm GmbH&CoKGaA

15/02/2011 15 mg/ 850 mg

Film-coated tablet 112 EU/1/06/354/010 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/03/2011


Competact Docpharm GmbH&CoKGaA

15/02/2011 15 mg/ 850 mg

Film-coated tablet 196 (2 x 98)

EU/1/06/354/011 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/03/2011

Competact Kohlpharma GmbH

07/06/2011 15 mg/ 850 mg

Film-coated tablet 112 EU/1/06/354/010 France Germany 30/06/2011

Comtess Docpharm GmbH&CoKGaA


Germany 17/11/2011

Comtess EuroPharma DK


Denmark 01/08/2011

Comtess Paranova Läkemedel AB


Sweden 11/08/2011

Cubicin CC Pharma 02/05/2011 350 mg Powder for solution for injection or infusion

1 vial EU/1/05/328/001 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 11/05/2011

Cubicin CC Pharma 02/05/2011 500 mg Powder for solution for injection or infusion

1 vial EU/1/05/328/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 11/05/2011

Cymbalta Abacus Medicine A/S

23/11/2011 30 mg Gastro-resistant capsule, hard

28 EU/1/04/296/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/12/2011



98 EU/1/04/296/009 Austria, Belgium, Cyprus, Finland, France, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/12/2011



28 EU/1/04/296/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/12/2011




98 EU/1/04/296/004 Austria, Belgium, Cyprus, Finland, France, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/12/2011

Cymbalta B2B Medical GmbH



Germany 03/05/2011

Cymbalta B2B Medical GmbH



Germany 03/05/2011

Cymbalta BB Farma s.r.l.


28 EU/1/04/296/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/05/2011




Germany 30/05/2011




Germany 23/06/2011




Germany 22/06/2011

Cymbalta Cross Healthcare Ltd


7 EU/1/04/296/006 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


17/02/2011

Cymbalta Haemato Pharm AG


28 EU/1/04/296/001 Austria, Belgium, Cyprus, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 28/04/2011




Denmark 28/04/2011





Denmark 28/04/2011

Cymbalta Pharmachim AB


28 EU/1/04/296/002 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 11/10/2011

Cymbalta Propharmed GmbH


98 EU/1/04/296/009 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/03/2011




Germany 30/03/2011




Germany 30/03/2011

Cymbalta Veron Pharma Vertriebs GmbH


98 EU/1/04/296/009 Austria, Belgium, Finland, France, Greece, Italy, Portugal, Sweden, The Netherlands, United Kingdom

Germany 13/07/2011

Cystagon CC Pharma 21/04/2011 150 mg Capsule, hard 100 EU/1/97/039/003 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/05/2011

Cystagon CC Pharma 21/04/2011 50 mg Capsule, hard 100 EU/1/97/039/001 Austria, Belgium, Denmark, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/05/2011

Dukoral Omnia Läkemedel AB

08/02/2011 - - Suspension of vaccine and effervescent granules for oral solution

2 x 1 dose EU/1/03/263/002 Belgium, France, Italy, Poland, Spain, The Netherlands, United Kingdom

Sweden 22/02/2011

DuoPlavin BR Pharma International Ltd

11/05/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/05/2011

DuoPlavin BR Pharma International Ltd

19/10/2011 75 mg/100 mg Film-coated tablet 100 x 1 EU/1/10/619/014 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011

DuoPlavin CC Pharma 21/04/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/05/2011


DuoPlavin Docpharm GmbH&CoKGaA

02/02/2011 75 mg/100 mg Film-coated tablet 100 x 1 EU/1/10/619/014 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/04/2011

DuoPlavin Docpharm GmbH&CoKGaA

02/02/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/04/2011

DuoPlavin Doncaster Pharmaceuticals Group Ltd

18/02/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


16/03/2011

DuoPlavin Dr Fisher Farma BV

02/02/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

19/04/2011

DuoPlavin Emra-Med 22/06/2011 75 mg/100 mg Film-coated tablet 100 x 1 EU/1/10/619/014 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/08/2011

DuoPlavin Kohlpharma GmbH

13/04/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 France, Italy, Spain Germany 24/05/2011

DuoPlavin Kohlpharma GmbH

13/04/2011 75 mg/100 mg Film-coated tablet 100 x 1 EU/1/10/619/014 France, Italy, Spain Germany 09/08/2011

DuoPlavin Medcor Pharmaceuticals BV

25/02/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

15/03/2011

DuoPlavin Pharma Westen GmbH

08/03/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/03/2011

DuoPlavin Veron Pharma Vertriebs GmbH

19/10/2011 75 mg/100 mg Film-coated tablet 28 EU/1/10/619/009 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 15/11/2011

DuoPlavin Veron Pharma Vertriebs GmbH

19/10/2011 75 mg/100 mg Film-coated tablet 100 x 1 EU/1/10/619/014 Austria, Belgium, France, Germany, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 15/11/2011


DuoTrav 2 Care 4 07/07/2010 40 µg /ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/338/002 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/01/2011

DuoTrav 2 Care 4 07/07/2010 40 µg /ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/338/001 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/01/2011

DuoTrav Abacus Medicine A/S

25/08/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/338/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/08/2011

DuoTrav Abacus Medicine A/S

25/08/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/338/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/08/2011

DuoTrav Cross Pharma AB

24/01/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/338/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 08/02/2011

DuoTrav Doncaster Pharmaceuticals Group Ltd

01/09/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/338/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


29/09/2011

DuoTrav Parallell Pharma AB

15/08/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/338/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 05/09/2011

DuoTrav Parallell Pharma AB

15/08/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/338/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 05/09/2011

DuoTrav Singad Pharma ApS

15/08/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/338/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 12/09/2011


DuoTrav Singad Pharma ApS

15/08/2011 40 µg /ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/338/002 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 12/09/2011

Dynastat Pharmachim AB

28/07/2011 40 mg Powder and solvent for solution for injection

5 vials + 5 ampoules

EU/1/02/209/008 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/08/2011

Ebixa Beragena Arzneimittel GmbH


Germany 17/11/2011

Ebixa Beragena Arzneimittel GmbH


Germany 17/11/2011

Ebixa Dr Fisher Farma BV

21/06/2011 10 mg Film-coated tablet 42 EU/1/02/219/017 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

27/06/2011

Ebixa Euro Registratie Collectief BV


The Netherlands

22/09/2011

Ebixa EuroPharma DK


Denmark 10/05/2011

Ebixa EuroPharma DK


Denmark 10/05/2011

Ebixa Medartuum AB 13/10/2011 20 mg Film-coated tablet 98 EU/1/02/219/045 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 25/11/2011

Ebixa Medcor Pharmaceuticals BV

03/01/2011 10 mg Film-coated tablet 42 EU/1/02/219/017 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

10/01/2011



13/05/2011 10 mg Film-coated tablet 98 EU/1/02/219/020 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

16/05/2011



The Netherlands

07/09/2011

Ebixa MTK Pharma GmbH

07/04/2011 10 mg Film-coated tablet 42 EU/1/02/219/017 Poland Germany 22/06/2011

Ebixa Omnia Läkemedel AB

30/11/2011 10 mg Film-coated tablet 100 EU/1/02/219/003 Germany, Greece, Italy, Spain, The Netherlands, United Kingdom

Sweden 07/12/2011

Ebixa Orifarm AB 24/01/2011 20 mg Film-coated tablet 98 EU/1/02/219/031 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 31/01/2011

Ebixa Orifarm AS 24/01/2011 20 mg Film-coated tablet 28 EU/1/02/219/024 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 28/02/2011

Ebixa Orifarm AS 24/01/2011 20 mg Film-coated tablet 98 EU/1/02/219/031 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 31/01/2011

Ebixa Paranova Danmark AS


Denmark 19/05/2011



05/04/2011 10 mg Film-coated tablet 28 EU/1/02/219/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, TheNetherlands, United Kingdom

Denmark 19/05/2011



Denmark 13/07/2011

Ebixa Paranova Läkemedel AB


Sweden 01/12/2011

Ebixa Paranova Läkemedel AB


Sweden 01/12/2011

Ebixa PCO Manufacturing

17/06/2011 10 mg Film-coated tablet 30 EU/1/02/219/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands


06/07/2011

Ebixa Pharmachim AB

06/06/2011 10 mg Film-coated tablet 30 EU/1/02/219/001 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 16/06/2011

Ebixa Pharmachim AB


Sweden 16/06/2011

Ebixa Pharmachim AB


Sweden 27/10/2011

Ebixa Pharmachim AB


Sweden 11/08/2011


Ebixa Pharmachim AB


Sweden 11/08/2011

Ebixa Pharmacodane Aps

07/06/2011 20 mg Film-coated tablet 98 EU/1/02/219/031 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 24/06/2011

Ebixa Pharmacodane Aps

07/06/2011 20 mg Film-coated tablet 28 EU/1/02/219/024 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 23/06/2011

ECALTA Orifarm AB 08/11/2011 100 mg Powder for concentrate for solution for infusion

1 vial EU/1/07/416/002 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 10/11/2011

ECALTA Orifarm AS 04/07/2011 100 mg Powder for concentrate for solution for infusion

1 vial EU/1/07/416/002 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 02/08/2011

Efient Amimed Direct Ltd

27/10/2010 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands


05/07/2011

Efient Amimed Direct Ltd

27/10/2010 5 mg Film-coated tablet 28 EU/1/08/503/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands


10/01/2011

Efient Emra-Med 13/09/2011 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 23/09/2011

Efient Emra-Med 13/09/2011 10 mg Film-coated tablet 98 EU/1/08/503/014 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 23/09/2011


Efient EuroPharma DK


Denmark 02/08/2011



Denmark 01/08/2011



Denmark 01/08/2011



Denmark 01/08/2011

Efient Medcor Pharmaceuticals BV


The Netherlands

05/05/2011

Efient Medcor Pharmaceuticals BV


The Netherlands

25/11/2011

Efient Mevita HandelsGmbH


Germany 13/04/2011



Germany 13/04/2011



Germany 05/05/2011



Germany 05/05/2011


Efient Orifarm AB 12/10/2011 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Sweden 22/11/2011

Efient Orifarm AS 27/10/2011 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/11/2011

Efient Paranova Danmark AS

28/10/2011 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 22/11/2011

Efient Pharmachim AB

09/10/2011 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 24/10/2011

Efient Swingward Ltd TA Medihealth

08/02/2011 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

10/02/2011

Efient Waymade PLC 31/01/2011 10 mg Film-coated tablet 28 EU/1/08/503/009 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


22/02/2011

Efient Waymade PLC 31/01/2011 5 mg Film-coated tablet 28 EU/1/08/503/002 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


24/02/2011

Elaprase Haemato Pharm AG


1 vial EU/1/06/365/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

07/06/2011

Elaprase Haemato Pharm AG



Denmark 07/06/2011


ellaOne Emra-Med 15/04/2011 30 mg Tablet 1 EU/1/09/522/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/06/2011

ellaOne Kohlpharma GmbH

31/03/2011 30 mg Tablet 1 EU/1/09/522/001 Austria Germany 13/04/2011

Emadine Kohlpharma GmbH

17/02/2011 0.05% Eye drops, solution 1 bottle EU/1/98/095/001 Czech Republic, Greece Germany 11/03/2011

Emend Dr Fisher Farma BV

14/12/2010 125 mg + 80 mg

Capsule, hard 1 capsule (125 mg) + 2 (80 mg)


The Netherlands

11/01/2011

Emend Dr Fisher Farma BV

23/09/2011 125 mg Capsule, hard 5 x 1 EU/1/03/262/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

03/10/2011

Emselex Beragena Arzneimittel GmbH


98 EU/1/04/294/026 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 25/05/2011

Emselex Emra-Med 25/07/2011 15 mg Prolonged release tablet


Germany 08/08/2011

Emselex EuroPharma DK



Denmark 03/08/2011




Denmark 03/08/2011


02/08/2011 7.5 mg Prolonged-release tablet


Denmark 03/08/2011





Denmark 03/08/2011

Emselex Pharmachim AB


28 EU/1/04/294/023 Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 15/08/2011



98 EU/1/04/294/026 Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 15/08/2011




Sweden 15/08/2011




Sweden 15/08/2011

Enbrel Abacus Medicine A/S

17/01/2011 25 mg Solution for injection in pre-filled syringe


EU/1/99/126/013 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 18/01/2011

Enbrel Abacus Medicine A/S



EU/1/99/126/017 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 18/01/2011

Enbrel Emra-Med 08/03/2010 50 mg Solution for injection in pre-filled pen

4 pre-filled pens + 8 alcohol swabs


Germany 26/01/2011

Enbrel Haemato Pharm AG

31/03/2011 50 mg Solution for injection in pre-filled pen



Germany 24/05/2011


Enbrel Haemato Pharm AG




Germany 16/08/2011

Enbrel Kohlpharma GmbH



EU/1/99/126/021 France, The Netherlands Germany 28/11/2011

Enbrel Orifarm AB 31/03/2011 25 mg Solution for injection in pre-filled syringe


EU/1/99/126/013 Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 07/04/2011

Enbrel Orifarm AB 31/03/2011 50 mg Solution for injection in pre-filled syringe



Sweden 07/04/2011

Enbrel Orifarm AB 06/06/2011 50 mg Solution for injection in pre-filled pen



Sweden 24/06/2011

Enbrel Orifarm AB 16/11/2011 25 mg Powder and solvent for solution for injection

4 vials + 4 pre-filled syringes + 8 syringes + 20 needles + 24 alcohol swabs


Sweden 16/12/2011

Enbrel Pharma Westen GmbH




Germany 20/01/2011

Enbrel Pharma Westen GmbH




Germany 20/01/2011

Enbrel Pharmachim AB




Sweden 10/11/2011


Enbrel Pharmachim AB




Sweden 10/11/2011

erbitux Haemato Pharm AG


1 vial EU/1/04/281/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 06/04/2011

erbitux Haemato Pharm AG


1 vial EU/1/04/281/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 06/04/2011

Erbitux Orifarm AS 11/05/2011 5 mg/ml Solution for infusion

1 vial EU/1/04/281/005 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 04/07/2011

Eucreas 2 Care 4 15/11/2011 50 mg / 850 mg

Film-coated tablet 60 EU/1/07/425/003 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 30/11/2011

Eucreas 2 Care 4 15/11/2011 50 mg / 850 mg

Film-coated tablet 180 EU/1/07/425/005 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 30/11/2011

Eucreas Abacus Medicine A/S

18/10/2011 50 mg / 850 mg

Film-coated tablet 60 EU/1/07/425/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 08/11/2011

Eucreas Abacus Medicine A/S

20/10/2011 50 mg / 850 mg

Film-coated tablet 180 EU/1/07/425/005 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 08/11/2011

Eucreas CC Pharma 18/01/2011 50 mg / 1000 mg

Film-coated tablet 180 tablet (3 x 60)


Germany 28/01/2011


Eucreas CC Pharma 18/01/2011 50 mg / 850 mg



Germany 28/01/2011

Eucreas EuroPharma DK

29/03/2011 50 mg / 1000 mg

Film-coated tablet 60 EU/1/07/425/009 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/04/2011


29/03/2011 50 mg / 1000 mg


Denmark 26/04/2011


02/08/2011 50 mg / 850 mg


Denmark 03/08/2011


03/08/2011 50 mg / 850 mg


Denmark 03/08/2011

Eucreas Orifarm AS 18/07/2011 50 mg / 1000 mg

Film-coated tablet 60 EU/1/07/425/009 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 02/08/2011

Eucreas Orifarm AS 04/11/2011 50 mg / 1000 mg

Film-coated tablet 180 EU/1/07/425/011 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 09/11/2011

Eucreas Paranova Danmark AS

28/04/2011 50 mg / 1000 mg


Denmark 17/05/2011


Eucreas Paranova Danmark AS

28/04/2011 50 mg / 1000 mg



Denmark 17/05/2011

Eucreas Pharmacodane Aps

24/01/2011 50 mg / 1000 mg

Film-coated tablet 60 EU/1/07/425/009 United Kingdom Denmark 25/05/2011

Eucreas Pharmacodane Aps

24/01/2011 50 mg / 1000 mg

Film-coated tablet 180 EU/1/07/425/011 United Kingdom Denmark 25/05/2011

Evista Mediwin Ltd 25/11/2011 60 mg Film-coated tablet 28 EU/1/98/073/002 Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

France 05/12/2011

Evista Mediwin Ltd 25/11/2011 60 mg Film-coated tablet 84 EU/1/98/073/003 Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

France 05/12/2011

EVRA BCN Farma SL 12/11/2010 - - Transdermal patch 3 transdermal patches

EU/1/02/223/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, The Netherlands, United Kingdom

Spain 14/01/2011

EVRA Elpis Ltd. 09/08/2011 - - Transdermal patch 3 transdermal patches

EU/1/02/223/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Latvia 25/08/2011

EVRA Medkon Hurt Sp. z o.o.

08/07/2011 - - Transdermal patch 3 transdermal patches

EU/1/02/223/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 16/08/2011


EVRA Storkpharm Sp.z.o.o.

25/01/2011 - - Transdermal patch 3 transdermal patches

EU/1/02/223/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 27/05/2011

Exelon Chemilines Ltd 21/09/2011 4.6 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/020 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands


10/10/2011

Exelon Delfarma SpZoo

25/10/2011 3 mg Capsule, hard 28 EU/1/98/066/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands

Poland 08/12/2011

Exelon Delfarma SpZoo

25/10/2011 3 mg Capsule, hard 56 EU/1/98/066/005 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 08/12/2011

Exelon Dr Fisher Farma BV

28/06/2011 9.5 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/024 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

25/07/2011

Exelon Emra-Med 08/11/2011 3 mg Capsule, hard 112 EU/1/98/066/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011

Exelon Emra-Med 08/11/2011 3 mg Capsule, hard 56 EU/1/98/066/005 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011


Exelon EuroPharma DK

05/01/2011 4.6 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/020 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 17/01/2011


05/01/2011 4.6 mg / 24 hours

Transdermal patch 60 (30 x 2) sachets


Denmark 17/01/2011


05/01/2011 4.6 mg / 24 hours

Transdermal patch 90 (30 x 3) sachets


Denmark 17/01/2011


05/01/2011 9.5 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/024 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 17/01/2011


05/01/2011 9.5 mg / 24 hours

Transdermal patch 60 sachets (30 x 2 sachets)


Denmark 17/01/2011


05/01/2011 9.5 mg / 24 hours

Transdermal patch 90 sachets (30 x 3 sachets)


Denmark 17/01/2011

Exelon PCO Manufacturing

06/06/2011 4.6 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/020 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands


21/06/2011

Exelon PCO Manufacturing

06/06/2011 9.5 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/024 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands


21/06/2011

Exelon S.C. Farmastore Prest S.R.L.

26/01/2011 4.6 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/020 Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Romania 24/03/2011


Exelon S.C. Farmastore Prest S.R.L.

26/01/2011 9.5 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/066/024 Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Romania 24/03/2011

Exforge Autumn Healthcare Ltd

19/04/2011 10 mg/160 mg Film-coated tablet 28 EU/1/06/370/019 Ireland, United Kingdom Ireland, United Kingdom

17/05/2011



17/05/2011



17/05/2011

Exforge PCO Manufacturing

07/05/2009 10 mg/160 mg Film-coated tablet 28 EU/1/06/370/019 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


15/02/2011




15/02/2011




15/02/2011

Exforge Pharmachim AB

07/09/2011 10 mg/160 mg Film-coated tablet 28 EU/1/06/370/019 Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 27/09/2011



Sweden 27/09/2011



Sweden 27/09/2011



Sweden 27/09/2011



Sweden 27/09/2011




Sweden 27/09/2011

Exforge HCT Dr Fisher Farma BV

16/11/2010 10 mg/ 160 mg/ 12.5 mg


The Netherlands

21/03/2011


16/11/2010 10 mg/ 320 mg/ 25 mg


The Netherlands

21/03/2011


16/11/2010 5 mg/ 160 mg/ 12.5 mg


The Netherlands

21/03/2011

Exforge HCT Eureco-Pharma B.V.

05/05/2010 10 mg/ 160 mg/ 12.5 mg


The Netherlands

11/01/2011


05/05/2010 10 mg/ 160 mg/ 25 mg


The Netherlands

11/01/2011


05/05/2010 10 mg/ 320 mg/ 25 mg


The Netherlands

11/01/2011


05/05/2010 5 mg/ 160 mg/ 12.5 mg


The Netherlands

11/01/2011


05/05/2010 5 mg/ 160 mg/ 25 mg


The Netherlands

11/01/2011


Exforge HCT Euro Registratie Collectief BV

27/01/2011 10 mg/ 320 mg/ 25 mg

Film-coated tablet 28 EU/1/09/569/050 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

01/02/2011

Exjade Kohlpharma GmbH

07/02/2011 250 mg Dispersible tablet 84 EU/1/06/356/004 Romania, United Kingdom Germany 21/03/2011

Exjade Kohlpharma GmbH

29/03/2011 125 mg Dispersible tablet 84 EU/1/06/356/002 France, Spain, United Kingdom Germany 01/04/2011

Extavia Orifarm AB 01/02/2011 250 µg / ml Powder and solvent for solution for injection

15 vials + 15 pre-filled syringes


Sweden 03/03/2011

Extavia Orifarm AS 13/12/2010 250 µg / ml Powder and solvent for solution for injection



Denmark 03/01/2011

Fabrazyme Orifarm AS 11/05/2011 35 mg Powder for concentrate for solution for infusion

1 vial EU/1/01/188/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/06/2011

Faslodex Axicorp Pharma GmbH

13/05/2011 250 mg/5 ml Solution for injection

1 pre-filled syringe + 1 safety needle

EU/1/03/269/001 Austria, Belgium, Bulgaria, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 19/05/2011

Faslodex Dr Fisher Farma BV



EU/1/03/269/001 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

02/08/2011

Faslodex Dr Fisher Farma BV


2 pre-filled syringes + 2 safety needles


The Netherlands

13/12/2011


Faslodex Euro Registratie Collectief BV




The Netherlands

18/11/2011

Faslodex Haemato Pharm AG



EU/1/03/269/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

26/01/2011





Denmark 21/03/2011





Denmark 21/03/2011

Faslodex Pharma Westen GmbH




Germany 08/11/2011

Faslodex Propharmed GmbH



EU/1/03/269/001 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 19/04/2011

Fendrix Medcor Pharmaceuticals BV

01/04/2011 20 µg/0.5 ml Suspension for injection



The Netherlands

04/04/2011

Ferriprox Abacus Medicine A/S

13/07/2011 500 mg Film-coated tablet 1 bottle EU/1/99/108/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 20/07/2011


Firmagon Dr Fisher Farma BV

25/05/2011 80 mg Powder and solvent for solutionfor injection

1 vial + 1 vial + 1 syringe + 2 needles


The Netherlands

28/06/2011

Firmagon Dr Fisher Farma BV


2 vials + 2 vials + 2 syringes+ 4 needles


The Netherlands

03/08/2011

Firmagon Euro Registratie Collectief BV




The Netherlands

03/11/2011

Firmagon Medcor Pharmaceuticals BV


2 vials + 2 vials + 2 syringes+ 4 needles


The Netherlands

06/09/2011

Firmagon Medcor Pharmaceuticals BV




The Netherlands

06/09/2011

Forsteo Mevita HandelsGmbH

14/01/2011 20 µg/80 µl Solution for injection

1 pre-filled pen

EU/1/03/247/001 Austria, Belgium, France, Greece, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 09/03/2011

Forsteo Omnia Läkemedel AB

13/12/2011 20 µg/80 µl Solution for injection

1 pre-filled pen

EU/1/03/247/001 Austria, Belgium, Bulgaria, Finland, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 19/12/2011

Fosavance Axicorp Pharma GmbH

16/10/2009 70 mg/ 2800 IU

Tablet 1 x 4 EU/1/05/310/002 Austria, Belgium, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/02/2011

Fosavance Axicorp Pharma GmbH

16/10/2009 70 mg/ 2800 IU

Tablet 3 x 4 EU/1/05/310/004 Austria, Belgium, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/02/2011

FOSAVANCE Axicorp Pharma GmbH

27/09/2011 70 mg / 5600 IU

Tablet 4 EU/1/05/310/007 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/10/2011


FOSAVANCE Axicorp Pharma GmbH

28/09/2011 70 mg / 5600 IU

Tablet 12 EU/1/05/310/008 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/10/2011

FOSAVANCE Clear Pharmacy

05/09/2011 70 mg / 5600 IU

Tablet 4 EU/1/05/310/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


27/09/2011

FOSAVANCE Dr Fisher Farma BV

10/08/2011 70 mg / 5600 IU

Tablet 4 EU/1/05/310/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

30/08/2011

Fosavance Eureco-Pharma B.V.

15/03/2010 70 mg/ 2800 IU

Tablet 1 x 4 EU/1/05/310/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

25/03/2011

FOSAVANCE PCO Manufacturing

17/05/2010 70 mg / 5600 IU

Tablet 4 EU/1/05/310/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


13/01/2011

Fosavance Pharma Lab 25/03/2010 70 mg / 5600 IU

Tablet 12 EU/1/05/310/008 Belgium France 11/01/2011

FOSAVANCE PHARMECO ApS

24/08/2011 70 mg / 2800 IU

Tablet 1 x 4 EU/1/05/310/002 Czech Republic, Greece, Italy, Lithuania, Romania, United Kingdom

Denmark 21/09/2011

FOSAVANCE PHARMECO ApS

24/08/2011 70 mg / 2800 IU

Tablet 3 x 4 EU/1/05/310/004 Czech Republic, Greece, Italy, Lithuania, Romania, United Kingdom

Denmark 21/09/2011

Galvus Dr Fisher Farma BV


The Netherlands

12/05/2011

Galvus Swingward Ltd TA Medihealth

28/11/2011 50 mg Tablet 28 EU/1/07/414/003 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

06/12/2011

Ganfort Autumn Healthcare Ltd

23/05/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Ireland, United Kingdom Ireland, United Kingdom

23/06/2011

Ganfort Doncaster Pharmaceuticals Group Ltd

07/09/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Poland Ireland, Malta, United Kingdom

04/11/2011


Ganfort Eureco-Pharma B.V.

28/11/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

02/12/2011

Ganfort EuroPharma DK

30/09/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 09/11/2011

Ganfort EuroPharma DK

30/09/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/340/002 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 09/11/2011

Ganfort Mediwin Ltd 14/01/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

France 18/01/2011

Ganfort Oy Cross Pharma AB

01/03/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/340/002 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Finland 02/03/2011

Ganfort Paranova Läkemedel AB

14/03/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Sweden 11/04/2011

Ganfort Paranova Läkemedel AB

14/03/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/340/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 11/04/2011

Ganfort Paranova OY 14/03/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 3 bottles EU/1/06/340/002 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 10/05/2011


Ganfort PCO Manufacturing

11/05/2010 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom


04/02/2011

Ganfort STRATHCLYDE PHARMACEUTICALS LTD

01/09/2011 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


13/09/2011

Ganfort Swingward Ltd TA Medihealth

11/04/2007 300 µg/ml + 5 mg/ml

Eye drops, solution 1 bottle EU/1/06/340/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands

United Kingdom

16/11/2011

Gardasil Cross Pharma AB


1 pre-filled syringe + 2 needles

EU/1/06/357/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 04/05/2011

Gardasil Emra-Med 30/06/2011 - - Suspension for injection



Germany 16/09/2011

Gardasil Parallell Pharma AB



EU/1/06/357/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/04/2011

Gilenya Haemato Pharm AG

28/06/2011 0.5 mg Capsule, hard 28 EU/1/11/677/005 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 11/07/2011

Glivec Clear Pharmacy

25/07/2011 100 mg Film-coated tablet 60 EU/1/01/198/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


29/07/2011

Glivec Clear Pharmacy



29/07/2011


Glivec MedicoPharm AG


Germany 09/02/2011

Glivec MedicoPharm AG


Germany 09/02/2011

Glivec Orifarm AB 12/05/2011 400 mg Film-coated tablet 30 EU/1/01/198/010 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 19/05/2011

Glivec Paranova Läkemedel AB


Sweden 27/10/2011

GONAL-f 2 Care 4 20/06/2011 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml)

Solution for injection in pre-filled pen

1 pre-filled pen + 14 needles

EU/1/95/001/035 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/07/2011

GONAL-f Axicorp Pharma GmbH

04/04/2011 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml)



EU/1/95/001/034 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/05/2011

GONAL-f Axicorp Pharma GmbH




EU/1/95/001/035 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/05/2011

GONAL-f eurorx Arzneimittel GmbH




EU/1/95/001/033 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 26/01/2011







Germany 26/01/2011






Germany 26/01/2011

GONAL-f Paranova Danmark AS


Powder and solvent for solution for injection

1 vial + 1 pre-filled syringe + 6 disposable syringes

EU/1/95/001/031 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 15/08/2011






Denmark 05/12/2011






Denmark 05/12/2011

GONAL-f Paranova Läkemedel AB





Sweden 09/12/2011

GONAL-f Paranova Läkemedel AB

19/10/2011 450 IU/0.75 ml (33 micrograms/0.75 ml)




Sweden 09/12/2011


Halaven Haemato Pharm AG

20/05/2011 0.44 mg/ml Solution for injection


Denmark 23/05/2011

Halaven Haemato Pharm AG

30/06/2011 0.44 mg/ml Solution for injection


Austria, Germany

05/07/2011

Hepsera Delfarma SpZoo

11/08/2011 10 mg Tablet 30 EU/1/03/251/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 17/08/2011

Hepsera Inopha GmbH 30/03/2011 10 mg Tablet 30 EU/1/03/251/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

05/04/2011

Hepsera Parallell Pharma AB

19/08/2011 10 mg Tablet 30 EU/1/03/251/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/09/2011

Hepsera Propharmed GmbH

19/05/2011 10 mg Tablet 30 EU/1/03/251/001 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/05/2011

Hepsera Propharmed GmbH

19/05/2011 10 mg Tablet 3 x 30 EU/1/03/251/002 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/05/2011

Herceptin Abacus Medicine A/S


1 vial EU/1/00/145/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 25/07/2011


Herceptin Dr Fisher Farma BV



The Netherlands

05/04/2011

Herceptin Inopha GmbH 29/04/2011 150 mg Powder for concentrate for solution for infusion


Sweden 19/05/2011

Herceptin Paranova Läkemedel AB



Sweden 01/06/2011

Herceptin Pharmachim AB



Sweden 14/06/2011

Herceptin Simgen GmbH 24/05/2011 150 mg Powder for concentrate for solution for infusion

1 vial EU/1/00/145/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/06/2011

Hirobriz Breezhaler

CC Pharma 02/12/2011 300 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler


Germany 21/12/2011

Hirobriz Breezhaler

CC Pharma 02/12/2011 300 µg Inhalation powder, hard capsule

3 x (30 + 1 inhaler)


Germany 21/12/2011

Hirobriz Breezhaler

Dr Fisher Farma BV

18/11/2011 150 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler


The Netherlands

07/12/2011


Hirobriz Breezhaler

Dr Fisher Farma BV


30 (3 x 10) + 1 inhaler


The Netherlands

07/12/2011

Hirobriz Breezhaler

Emra-Med 18/07/2011 300 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler


Germany 19/09/2011

Hirobriz Breezhaler

Emra-Med 18/07/2011 300 µg Inhalation powder, hard capsule



Germany 19/09/2011

Humalog Euro Registratie Collectief BV

28/09/2011 100 U/ml Solution for injection

5 pens EU/1/96/007/031 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

05/10/2011

Humalog Medcor Pharmaceuticals BV

15/03/2011 100 U/ml Suspension for injection

5 cartridges EU/1/96/007/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, United Kingdom

The Netherlands

28/03/2011



5 pens EU/1/96/007/033 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, United Kingdom

The Netherlands

28/03/2011



5 pens EU/1/96/007/031 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, United Kingdom

The Netherlands

28/03/2011

Humalog Mix50 Pharma Westen GmbH


2 x 5 pens EU/1/96/007/036 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/02/2011

Humira Axicorp Pharma GmbH


6 pre-filled pens + 6 alcohol pads in a blister


Germany 13/07/2011


Humira Axicorp Pharma GmbH




Germany 11/07/2011

Humira CC Pharma 11/10/2011 40 mg/0.8 ml Solution for injection

2 carton pack. Each carton contains: 1 vial + 1 syringe + 1 sterile adapter + 2 alcohol pads


Germany 24/10/2011

Humira Orifarm AS 04/05/2011 40 mg Solution for injection



Denmark 06/06/2011

Humira Veron Pharma Vertriebs GmbH


2 pre-filled syringes + 2 alcohol pads

EU/1/03/256/003 Austria Germany 14/02/2011

Hycamtin EuroPharma DK

04/02/2011 0.25 mg Capsule, hard 10 EU/1/96/027/006 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 21/02/2011

Hycamtin EuroPharma DK

04/02/2011 1 mg Capsule, hard 10 EU/1/96/027/007 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 21/02/2011

Hycamtin Medartuum AB 17/10/2011 4 mg Powder for concentrate for solution for infusion

1 vial (17 ml)


Sweden 29/11/2011


Hycamtin Omnia Läkemedel AB


1 vial (17 ml)

EU/1/96/027/003 France, Greece, Italy, Lithuania, Spain, United Kingdom

Sweden 24/05/2011

Hycamtin Omnia Läkemedel AB

11/05/2011 1 mg Capsule, hard 10 EU/1/96/027/007 Bulgaria, Germany, Spain, The Netherlands, United Kingdom

Sweden 09/06/2011

Hycamtin Orifarm AB 14/12/2011 1 mg Capsule, hard 10 EU/1/96/027/007 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 21/12/2011

Infanrix hexa CC Pharma 06/12/2010 - - Powder and suspension for suspension for injection



Germany 07/01/2011

Infanrix hexa CC Pharma 21/06/2011 - - Powder and suspension for suspension for injection



Germany 13/07/2011

Infanrix hexa Pharma Westen GmbH

06/05/2011 - - Powder and suspension for suspension for injection

50 vials + 50 pre-filledsyringes + 100 needles


Germany 25/05/2011

Inovelon 2 Care 4 27/10/2011 400 mg Film-coated tablet 100 EU/1/06/378/015 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/11/2011

Inovelon Emra-Med 30/05/2011 400 mg Film-coated tablet 200 EU/1/06/378/016 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/06/2011

Inovelon Orifarm AS 07/10/2011 400 mg Film-coated tablet 60 EU/1/06/378/014 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 25/10/2011

Inovelon Orifarm AS 07/10/2011 400 mg Film-coated tablet 100 EU/1/06/378/015 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 25/10/2011


Insuman CC Pharma 03/01/2011 100 IU/ml Suspension for injection

10 cartridges

EU/1/97/030/062 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Hungary, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/01/2011

Insuman Basal Emra-Med 24/01/2011 100 IU/ml OptiSet, suspension for injection

5 pens EU/1/97/030/071 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/02/2011

Insuman Basal Emra-Med 24/01/2011 100 IU/ml OptiSet, suspension for injection


Germany 02/02/2011

Insuman Basal Emra-Med 30/06/2011 100 IU/ml Suspension for injection

5 cartridges EU/1/97/030/035 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/09/2011

Insuman Basal Emra-Med 30/06/2011 100 IU/ml Suspension for injection

10 cartridges


Germany 16/09/2011

Insuman Comb 25 Emra-Med 12/05/2011 100 IU/ml OptiSet, suspension for injection


Germany 16/06/2011

Insuman Comb 25 Emra-Med 12/05/2011 100 IU/ml OptiSet, suspension for injection


Germany 16/06/2011


Insuman Comb 25 Pharma Westen GmbH

22/07/2011 100 IU/ml Suspension for injection

10 pre-filled pens

EU/1/97/030/163 Austria, Belgium, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/09/2011

Insuman Comb 50 Pharma Westen GmbH

22/07/2011 100 IU/ml OptiSet, suspension for injection

10 pens EU/1/97/030/084 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/09/2011

Insuman Rapid Emra-Med 01/03/2011 100 IU/ml Solution for injection

5 pre-filled pens


Germany 15/04/2011

Insuman Rapid Emra-Med 01/03/2011 100 IU/ml Solution for injection

10 pre-filled pens


Germany 15/04/2011

Insuman Rapid Emra-Med 13/04/2011 100 IU/ml OptiSet, solution for injection


Germany 15/04/2011

Insuman Rapid Emra-Med 13/04/2011 100 IU/ml OptiSet, solution for injection


Germany 15/04/2011

INTELENCE Orifarm AS 16/11/2011 100 mg Tablet 120 EU/1/08/468/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 24/11/2011

Intrinsa Doncaster Pharmaceuticals Group Ltd

29/11/2010 300 µ/ 24 hours

Transdermal patch 8 patches EU/1/06/352/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


10/01/2011


Intrinsa G-Pharma Ltd 12/01/2011 300 µg/ 24 hours

Transdermal patch 8 patches EU/1/06/352/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


26/01/2011

Invanz Omnia Läkemedel AB

04/10/2011 1 g Powder for concentrate for solution for infusion

1 vial EU/1/02/216/001 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/10/2011

Invanz Omnia Läkemedel AB


10 vials EU/1/02/216/002 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, The Netherlands, United Kingdom

Sweden 07/12/2011

Invanz Orifarm AB 23/11/2011 1 g Powder for concentrate for solution for infusion


Sweden 23/11/2011

Invanz Orifarm AB 23/11/2011 1 g Powder for concentrate for solution for infusion


Sweden 23/11/2011

Invanz Paranova Danmark AS



Denmark 07/07/2011

Invega 2 Care 4 07/09/2011 3 mg Prolonged-release tablet

28 EU/1/07/395/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 23/09/2011


28 EU/1/07/395/006 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/09/2011


28 EU/1/07/395/011 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/09/2011

Invega Abacus Medicine A/S


28 EU/1/07/395/001 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 24/10/2011





Denmark 24/10/2011




Denmark 24/10/2011

Invega EuroPharma DK


28 EU/1/07/395/011 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 04/04/2011




Denmark 07/06/2011




Denmark 07/06/2011

Invega Orifarm AB 09/02/2011 3 mg Prolonged-release tablet

28 EU/1/07/395/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 23/03/2011

Invega Orifarm AS 09/02/2011 3 mg Prolonged-release tablet


Denmark 05/05/2011

Invega PCO Manufacturing


28 EU/1/07/395/006 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


03/02/2011

Invega PCO Manufacturing


28 EU/1/07/395/026 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands


10/06/2011


Invirase Abacus Medicine A/S

23/06/2011 500 mg Film-coated tablet 1 bottle EU/1/96/026/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 02/08/2011

Invirase Haemato Pharm AG

30/05/2011 500 mg Film-coated tablet 1 bottle EU/1/96/026/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 22/06/2011

Invirase Orifarm AS 05/01/2011 500 mg Film-coated tablet 1 bottle EU/1/96/026/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 15/01/2011

Isentress Dr Fisher Farma BV


The Netherlands

15/12/2011

Ixiaro Abacus Medicine A/S

04/10/2011 6 µg Suspension for injection


EU/1/08/501/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 27/10/2011

Janumet 2 Care 4 06/07/2011 50 mg / 1000 mg

Film-coated tablet 196 EU/1/08/455/013 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Sweden 12/07/2011

Janumet Dr Fisher Farma BV

22/09/2010 50 mg / 850 mg


The Netherlands

25/02/2011


Janumet Medartuum AB 12/10/2011 50 mg / 1000 mg



Sweden 08/11/2011

Janumet Orifarm AB 25/03/2011 50 mg / 1000 mg

Film-coated tablet 196 EU/1/08/455/013 Austria, Belgium, Cyprus, Denmark, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 13/04/2011

Janumet Paranova Danmark AS

24/10/2011 50 mg / 1000 mg

Film-coated tablet 196 EU/1/08/455/013 Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 22/11/2011

Janumet Paranova Danmark AS

24/10/2011 50 mg / 1000 mg


Denmark 22/11/2011

Janumet PCO Manufacturing

12/08/2011 50 mg / 850 mg

Film-coated tablet 56 EU/1/08/455/003 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Romania, Spain, Sweden, The Netherlands


16/08/2011

Janumet Pharmachim AB

26/09/2011 50 mg / 1000 mg

Film-coated tablet 56 EU/1/08/455/010 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/10/2011

Janumet Pharmachim AB

26/09/2011 50 mg / 1000 mg

Film-coated tablet 196 EU/1/08/455/013 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/10/2011

Januvia B&S Healthcare Ltd



28/11/2011


Januvia Cross Pharma AB

17/01/2011 100 mg Film-coated tablet 28 EU/1/07/383/014 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 25/02/2011

Januvia Cross Pharma AB

20/01/2011 100 mg Film-coated tablet 98 EU/1/07/383/017 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 25/02/2011

Januvia Omnia Läkemedel AB

13/05/2011 100 mg Film-coated tablet 98 EU/1/07/383/017 Belgium, France, Greece, Italy, Spain, The Netherlands, United Kingdom

Sweden 22/06/2011

Januvia Orifarm AB 02/02/2011 100 mg Film-coated tablet 98 EU/1/07/383/017 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 17/02/2011

Januvia Paranova Läkemedel AB


Sweden 07/12/2011

Januvia Paranova Läkemedel AB


Sweden 07/12/2011

Januvia STRATHCLYDE PHARMACEUTICALS LTD



17/02/2011


Kaletra Abacus Medicine A/S

19/01/2011 200 mg / 50 mg

Film-coated tablet 120 EU/1/01/172/004 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Cyprus 24/01/2011


24/01/2011 100 mg / 25mg

Film-coated tablet 60 EU/1/01/172/006 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 27/01/2011


24/01/2011 200 mg / 50 mg

Film-coated tablet 120 EU/1/01/172/004 Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 27/01/2011

Kaletra Axicorp Pharma GmbH

27/01/2011 200 mg / 50 mg

Film-coated tablet 120 EU/1/01/172/005 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/02/2011


04/05/2011 200 mg / 50 mg

Film-coated tablet 120 EU/1/01/172/004 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/05/2011


28/06/2011 200 mg / 50 mg


EU/1/01/172/008 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/07/2011

Kaletra CC Pharma 11/07/2011 200 mg / 50 mg



Germany 27/07/2011

Kaletra Emra-Med 02/05/2011 200 mg / 50 mg



Germany 17/05/2011

Kaletra Haemato Pharm AG

26/05/2011 200 mg / 50 mg

Film-coated tablet 120 (10 x 12) ; blister

EU/1/01/172/008 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 31/05/2011

Kaletra Kohlpharma GmbH

07/06/2011 200 mg / 50 mg


EU/1/01/172/008 Norway, Sweden, The Netherlands, United Kingdom

Germany 29/06/2011


Kaletra MedicoPharm AG

02/02/2011 200 mg / 50 mg


EU/1/01/172/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 21/02/2011

Kaletra MedicoPharm AG

11/10/2011 200 mg / 50 mg



Germany 09/11/2011

Kaletra Orifarm OY 24/02/2011 200 mg / 50 mg

Film-coated tablet 120 EU/1/01/172/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 13/04/2011

Kaletra Paranova OY 10/03/2011 200 mg / 50 mg

Film-coated tablet 120 EU/1/01/172/004 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 14/04/2011

Kaletra Pharma Westen GmbH

01/03/2011 200 mg / 50 mg



Germany 19/04/2011

Kaletra Pharma Westen GmbH

06/06/2011 200 mg / 50 mg



Germany 15/08/2011

KARVEA Beragena Arzneimittel GmbH

21/04/2011 150 mg Tablet 98 EU/1/97/049/006 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 05/05/2011

Karvea Beragena Arzneimittel GmbH


Germany 05/05/2011

Karvea Emra-Med 08/12/2011 75 mg Film-coated tablet 98 EU/1/97/049/020 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/12/2011

Karvea Kohlpharma GmbH

11/01/2011 75 mg Tablet 98 EU/1/97/049/003 Greece Germany 24/01/2011


Karvea MPT Pharma 04/07/2011 150 mg Film-coated tablet 28 EU/1/97/049/022 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


14/07/2011

Karvea MPT Pharma 04/07/2011 300 mg Film-coated tablet 28 EU/1/97/049/027 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


20/07/2011

Karvea Orifarm AB 11/03/2011 150 mg Film-coated tablet 98 EU/1/97/049/025 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 24/03/2011

Karvea Orifarm AB 11/03/2011 300 mg Film-coated tablet 98 EU/1/97/049/030 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 24/03/2011

Karvezide Axicorp Pharma GmbH

11/07/2011 150 mg/ 12.50 mg

Tablet 14 EU/1/98/085/003 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/07/2011


12/10/2011 300 mg/ 12.50 mg

Film-coated tablet 98 EU/1/98/085/020 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 10/11/2011


04/11/2011 150 mg/ 12.50 mg


Germany 14/11/2011

Karvezide B&S Healthcare Ltd

16/08/2011 150 mg/ 12.50 mg



02/09/2011


Karvezide B&S Healthcare Ltd

16/08/2011 300 mg/ 12.50 mg



02/09/2011

Karvezide Emra-Med 25/08/2011 150 mg/ 12.50 mg


Germany 31/08/2011

Karvezide Emra-Med 09/09/2011 300 mg/ 12.50 mg


Germany 07/11/2011

Karvezide Pharma Westen GmbH

23/03/2011 300 mg/ 12.50 mg


Germany 14/04/2011

Karvezide Waymade PLC 25/10/2011 150 mg/ 12.50 mg

Film-coated tablet 28 EU/1/98/085/012 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


27/10/2011

Karvezide Waymade PLC 25/10/2011 300 mg/ 12.50 mg

Film-coated tablet 28 EU/1/98/085/017 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


27/10/2011

Kentera PCO Manufacturing

01/06/2011 3.9 mg/ 24 h

Transdermal patch 8 transdermal patches



12/07/2011

Keppra 2 Care 4 22/07/2010 250 mg Film-coated tablet 100 EU/1/00/146/005 Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 06/01/2011


Denmark 12/01/2011



Denmark 31/01/2011


Denmark 12/01/2011

Keppra Abacus Medicine A/S


Denmark 06/01/2011



Denmark 03/01/2011



Denmark 04/01/2011


01/08/2011 100 mg/ml Oral solution 1 bottle + 1 oral syringe 10 ml


Denmark 30/09/2011

Keppra ADL Pharma GmbH


EU/1/00/146/027 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/04/2011


Keppra BB Farma s.r.l.


EU/1/00/146/027 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/06/2011

Keppra Chemilines Ltd 18/03/2010 1000 mg Film-coated tablet 60 EU/1/00/146/024 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands


05/07/2011

Keppra Kohlpharma GmbH


EU/1/00/146/032 Italy, The Netherlands Germany 25/08/2011

Keppra Lexon (UK) Ltd



28/03/2011

Keppra Orifarm AB 03/02/2011 750 mg Film-coated tablet 100 EU/1/00/146/019 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 02/03/2011

Keppra Paranova Danmark AS

13/07/2011 750 mg Film-coated tablet 100 EU/1/00/146/019 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 20/07/2011

Keppra Paranova Läkemedel AB


Sweden 18/05/2011

Keppra Paranova Läkemedel AB


Sweden 17/05/2011


Keppra PCO Manufacturing




14/07/2011

Keppra STRATHCLYDE PHARMACEUTICALS LTD



27/01/2011

Keppra Waymade PLC 04/03/2011 250 mg Film-coated tablet 30 EU/1/00/146/002 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


31/03/2011

Keppra Waymade PLC 07/03/2011 1000 mg Film-coated tablet 50 EU/1/00/146/023 Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


01/04/2011



01/04/2011



01/04/2011

Kinzalkomb MTK Pharma GmbH

07/06/2011 40 mg/ 12.5 mg

Tablet 98 EU/1/02/214/005 The Netherlands Germany 20/06/2011

Kinzalkomb MTK Pharma GmbH

07/06/2011 80 mg/ 12.5 mg

Tablet 98 EU/1/02/214/010 The Netherlands Germany 20/06/2011

Kiovig Axicorp Pharma GmbH



Germany 29/07/2011

Kiovig Axicorp Pharma GmbH



Germany 25/08/2011

Kiovig Dr Fisher Farma BV



The Netherlands

06/10/2011


Kiovig Medcor Pharmaceuticals BV



The Netherlands

15/03/2011

Kiovig Medcor Pharmaceuticals BV



The Netherlands

15/11/2011

Kiovig Pharma Westen GmbH



Germany 22/03/2011

Kiovig Pharma Westen GmbH



Germany 22/03/2011

Kivexa Axicorp Pharma B.V.

01/03/2011 600mg/ 300mg

Film-coated tablet 3 x 30 EU/1/04/298/003 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/03/2011

Kivexa Orifarm AB 11/03/2011 - - Film-coated tablet 30 EU/1/04/298/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 28/03/2011

Kivexa Orifarm OY 11/03/2011 600 mg/ 300 mg


Finland 17/03/2011

Kivexa Paranova OY 10/03/2011 - - Film-coated tablet 30 EU/1/04/298/002 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 14/04/2011

Kivexa Veron Pharma Vertriebs GmbH

19/10/2011 - - Film-coated tablet 30 EU/1/04/298/002 Austria, Belgium, France, Greece, Italy, Portugal, Spain, United Kingdom

Germany 23/11/2011


Lantus Cross Pharma AB


5 pre-filled pens


Sweden 25/02/2011

Lantus (SoloStar) Orifarm AB 01/09/2011 100 Units/ml Solution for injection

5 pre-filled pens


Sweden 27/09/2011

Lantus OptiClik PCO Manufacturing

03/09/2007 100 Units/ml Solution for injection in cartridge

5 cartridges EU/1/00/134/025 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


10/05/2011

Lantus OptiSet ABACUS MEDICINE A/S


5 pre-filled pens


Denmark 22/12/2011

Lantus OptiSet Medartuum AB 25/03/2010 100 Units/ml Solution for injection

5 pre-filled pens

EU/1/00/134/010 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/01/2011

Lantus SoloStar Orifarm OY 30/05/2011 100 Units/ml Solution for injection

5 pre-filled pens


Finland 30/06/2011

Lantus Solostar Paranova Danmark AS


5 pre-filled pens


Denmark 21/07/2011

Levemir Delphi Pharmaceuticals BV


5 cartridges EU/1/04/278/002 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, United Kingdom

The Netherlands

17/03/2011


Levemir Medartuum AB 25/08/2011 100 U/ml Solution for injection

5 cartridges EU/1/04/278/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 01/09/2011

Levemir Pharmachim AB


5 cartridges EU/1/04/278/002 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/08/2011

Levemir Pharmachim AB


5 pre-filled pens

EU/1/04/278/005 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/08/2011

Levemir FlexPen Medartuum AB 08/07/2011 100 U/ml Solution for injection

5 pre-filled pens


Sweden 20/07/2011

Levitra Amimed Direct Ltd



12/04/2011

Levitra Amimed Direct Ltd



07/12/2011

Levitra Euro Registratie Collectief BV


The Netherlands

24/11/2011

Levitra Euro Registratie Collectief BV


The Netherlands

24/11/2011

Levitra MedicoPharm AG


Germany 18/02/2011


Levitra Pharmachim AB

06/07/2011 10 mg Film-coated tablet 4 EU/1/03/248/006 Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 21/07/2011



Sweden 21/07/2011



Sweden 15/07/2011



Sweden 15/07/2011



Sweden 15/07/2011

Lucentis Dr Fisher Farma BV

06/07/2011 10 mg/ml Solution for injection


The Netherlands

18/07/2011

Lucentis Orifarm AB 01/02/2011 10 mg/ml Solution for injection


Sweden 17/03/2011

Lumigan BR Pharma International Ltd

10/02/2010 0.3 mg/ml Eye drops, solution 3 bottles EU/1/02/205/002 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 26/01/2011

Lumigan Parallell Pharma AB

24/10/2011 0.3 mg/ml Eye drops, solution 1 bottle EU/1/02/205/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, The Netherlands, United Kingdom

Sweden 29/11/2011


Lumigan Parallell Pharma AB

24/10/2011 0.3 mg/ml Eye drops, solution 3 bottles EU/1/02/205/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, The Netherlands, United Kingdom

Sweden 29/11/2011

Lyrica Abacus Medicine A/S

18/02/2011 150 mg Capsule, hard 56 EU/1/04/279/018 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 25/02/2011

Lyrica ADL Pharma GmbH

23/08/2010 75 mg Capsule, hard 14 EU/1/04/279/011 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 11/01/2011



Germany 11/01/2011


16/09/2010 300 mg Capsule, hard 100 EU/1/04/279/043 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 11/01/2011



Germany 12/01/2011

Lyrica BB Farma s.r.l.

20/06/2011 200 mg Capsule, hard 21 EU/1/04/279/020 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/07/2011



Germany 08/07/2011



Germany 08/07/2011




Germany 14/07/2011



Germany 14/07/2011

Lyrica BR Pharma International Ltd

23/09/2011 75 mg Capsule, hard 100 x 1 EU/1/04/279/013 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

10/10/2011

Lyrica CC Pharma 28/04/2011 150 mg Capsule, hard 100 x 1 EU/1/04/279/019 Norway Germany 16/05/2011

Lyrica CC Pharma 06/05/2011 225 mg Capsule, hard 56 EU/1/04/279/034 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/05/2011


Germany 07/06/2011


Germany 07/06/2011


Germany 06/10/2011


Germany 06/10/2011

Lyrica Docpharm GmbH&CoKGaA


Germany 23/08/2011

Lyrica Emra-Med 09/02/2011 300 mg Capsule, hard 100 EU/1/04/279/043 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/06/2011


Lyrica Ethigen Limited

07/10/2011 100 mg Capsule, hard 21 EU/1/04/279/014 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


19/10/2011




19/10/2011




19/10/2011




19/10/2011




19/10/2011




19/10/2011




19/10/2011





19/10/2011




19/10/2011




19/10/2011




19/10/2011




19/10/2011


07/10/2011 25 mg Capsule, hard 112 (2 x 56)

EU/1/04/279/026 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


19/10/2011




19/10/2011





19/10/2011




19/10/2011




19/10/2011




19/10/2011




19/10/2011




19/10/2011


11/11/2011 75 mg Capsule, hard 112 (2 x 56)

EU/1/04/279/027 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


23/11/2011


Lyrica EuroPharma DK

04/02/2011 300 mg Capsule, hard 56 EU/1/04/279/024 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/02/2011

Lyrica Ginova Ltd 28/06/2011 50 mg Capsule, hard 56 EU/1/04/279/008 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

18/08/2011

Lyrica Kosei Pharma UK Limited

23/05/2011 150 mg Capsule, hard 56 EU/1/04/279/018 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


21/06/2011




21/06/2011




21/06/2011




21/07/2011




18/07/2011





15/07/2011




19/07/2011




18/07/2011




19/07/2011




19/07/2011




19/07/2011





19/07/2011




19/07/2011




22/12/2011

Lyrica Lexon (UK) Ltd

21/03/2011 50 mg Capsule, hard 56 EU/1/04/279/008 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


05/04/2011

Lyrica Lexon (UK) Ltd



11/11/2011

Lyrica Mediwin Ltd 02/03/2011 25 mg Capsule, hard 100 EU/1/04/279/036 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands

United Kingdom

08/03/2011

Lyrica Orifarm AB 27/10/2011 225 mg Capsule, hard 56 EU/1/04/279/034 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 16/11/2011


Lyrica Orifarm AS 27/10/2011 225 mg Capsule, hard 56 EU/1/04/279/034 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/11/2011

Lyrica PCO Manufacturing

28/04/2010 200 mg Capsule, hard 84 EU/1/04/279/021 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


18/01/2011

Lyrica Pharmachim AB

15/04/2011 225 mg Capsule, hard 56 EU/1/04/279/034 Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Latvia, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 19/04/2011

Lyrica Propharmed GmbH

15/04/2011 100 mg Capsule, hard 21 EU/1/04/279/014 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/04/2011


15/04/2011 150 mg Capsule, hard 100 EU/1/04/279/040 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/04/2011



Germany 29/04/2011


15/04/2011 75 mg Capsule, hard 56 EU/1/04/279/012 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/04/2011



Germany 18/05/2011



Germany 29/08/2011


17/08/2011 75 mg Capsule, hard 100 x 1 EU/1/04/279/013 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/09/2011

Lyrica Waymade PLC 01/02/2011 75 mg Capsule, hard 100 x 1 EU/1/04/279/013 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


07/02/2011

Lyrica Waymade PLC 24/05/2011 100 mg Capsule, hard 21 EU/1/04/279/014 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


07/06/2011


Lysodren MedicoPharm AG

18/02/2010 500 mg Tablet 100 EU/1/04/273/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 26/01/2011

MabCampath Abacus Medicine A/S


3 vials EU/1/01/193/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 14/07/2011

MabCampath Medartuum AB 31/10/2011 30 mg/ml Concentrate for solution for infusion

3 vials EU/1/01/193/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 11/11/2011

MabCampath Orifarm AS 16/02/2011 30 mg/ml Concentrate for solution for infusion

3 vials EU/1/01/193/002 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 04/03/2011

MabCampath Orifarm OY 16/02/2011 30 mg/ml Concentrate for solution for infusion

3 vials EU/1/01/193/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 28/02/2011

Mabthera Abacus Medicine A/S

15/11/2011 100 mg Concentrate for solution for infusion

2 vials EU/1/98/067/001 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Cyprus 17/11/2011

Mabthera Abacus Medicine A/S


1 vial EU/1/98/067/002 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Cyprus 17/11/2011

Mabthera Pharmachim AB


2 vials EU/1/98/067/001 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 18/04/2011


Metalyse Lex ano UAB 09/03/2011 10000 Units Powder and solvent for solution for injection

1 vial + 1 pre-filled syringe + 1 vial adapter + 1 needle

EU/1/00/169/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Lithuania 24/03/2011

Metalyse Orifarm AB 14/09/2011 10000 Units Powder and solvent for solution for injection

1 vial + 1 pre-filled syringe + 1 vial adapter + 1 needle

EU/1/00/169/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 16/12/2011

Micardis AN Pharmacy Sp. z o.o.

21/02/2011 80 mg Tablet 28 EU/1/98/090/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 28/02/2011

Micardis Axicorp Pharma GmbH

10/01/2011 80 mg Tablet 98 EU/1/98/090/008 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/01/2011

Micardis BR Pharma International Ltd



13/12/2011

Micardis BR Pharma International Ltd



13/12/2011

Micardis Orifarm AB 15/12/2010 80 mg Tablet 98 EU/1/98/090/008 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, The Netherlands

Sweden 24/01/2011

Micardis Pharmachim AB

19/09/2011 20 mg Tablet 98 EU/1/98/090/012 Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 17/10/2011



19/09/2011 40 mg Tablet 28 EU/1/98/090/002 Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 11/10/2011


19/09/2011 40 mg Tablet 98 EU/1/98/090/004 Austria, Belgium, Czech Republic, Estonia, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 11/10/2011


29/11/2011 80 mg Tablet 28 EU/1/98/090/006 Austria, Belgium, Czech Republic, France, Germany, Greece, Italy, Malta, Norway, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 02/12/2011


29/11/2011 80 mg Tablet 98 EU/1/98/090/008 Austria, Belgium, Czech Republic, France, Germany, Greece, Italy, Malta, Norway, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 06/12/2011

Micardis STRATHCLYDE PHARMACEUTICALS LTD

15/12/2010 40 mg Tablet 28 EU/1/98/090/002 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom


28/02/2011




28/02/2011




01/04/2011




01/04/2011

Micardis Swingward Ltd TA Medihealth

19/08/2011 40 mg Tablet 14 EU/1/98/090/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

12/10/2011


Micardis Swingward Ltd TA Medihealth

01/09/2011 80 mg Tablet 14 EU/1/98/090/005 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

12/10/2011

MicardisPlus AN Pharmacy Sp. z o.o.

22/02/2011 80 mg/ 12.5 mg

Tablet 28 EU/1/02/213/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 28/02/2011

MicardisPlus Beragena Arzneimittel GmbH

24/02/2011 80 mg/ 12.5 mg

Tablet 98 EU/1/02/213/010 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 02/03/2011

MicardisPlus Beragena Arzneimittel GmbH

24/02/2011 80 mg/ 25 mg

Tablet 98 EU/1/02/213/023 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 02/03/2011

MicardisPlus BR Pharma International Ltd

10/05/2011 80 mg/ 25 mg

Tablet 14 EU/1/02/213/017 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands


28/09/2011

MicardisPlus BR Pharma International Ltd

10/05/2011 80 mg/ 25 mg

Tablet 28 EU/1/02/213/018 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands


28/09/2011

MicardisPlus Clear Pharmacy

17/12/2010 40 mg/ 12.5 mg

Tablet 28 EU/1/02/213/002 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom


10/01/2011

MicardisPlus Clear Pharmacy

17/12/2010 80 mg/ 12.5 mg

Tablet 28 EU/1/02/213/007 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom


10/01/2011

MicardisPlus Dr Fisher Farma BV

20/04/2011 80 mg/ 25 mg


The Netherlands

26/04/2011

MicardisPlus EU-Pharma BV 30/03/2011 80 mg/ 12.5 mg


The Netherlands

12/04/2011


MicardisPlus Imed Healthcare Ltd

11/07/2011 80 mg/ 12.5 mg

Tablet 28 EU/1/02/213/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


22/07/2011

MicardisPlus Pharmachim AB

09/09/2011 80 mg/ 12.5 mg

Tablet 28 EU/1/02/213/007 Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 26/09/2011

MicardisPlus Pharmachim AB

09/09/2011 80 mg/ 12.5 mg

Tablet 98 EU/1/02/213/010 Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 26/09/2011

MicardisPlus PI-Pharma N.V.

15/10/2010 80 mg/ 12.5 mg

Tablet 28 EU/1/02/213/007 Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Belgium 11/01/2011

MicardisPlus PI-Pharma N.V.

12/01/2011 80 mg/ 12.5 mg

Tablet 98 EU/1/02/213/010 Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Belgium 20/01/2011

MicardisPlus STRATHCLYDE PHARMACEUTICALS LTD

07/02/2011 40 mg/ 12.5 mg

Tablet 14 EU/1/02/213/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom


01/03/2011


07/02/2011 80 mg/ 12.5 mg



01/03/2011


02/03/2011 40 mg/ 12.5 mg



03/03/2011



02/03/2011 80 mg/ 12.5 mg



03/03/2011

MicardisPlus Vital Supplies UK Limited

17/06/2010 80 mg/ 25 mg

Tablet 28 EU/1/02/213/018 France, Germany, Greece, Italy, Portugal, Spain, Sweden, The Netherlands


24/01/2011

Mimpara Dr Fisher Farma BV


The Netherlands

20/04/2011

Mimpara Haemato Pharm AG


Denmark 11/04/2011



Denmark 11/04/2011



Denmark 11/04/2011

Mimpara Medartuum AB 07/10/2011 60 mg Film-coated tablet 28 EU/1/04/292/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 19/10/2011


Mimpara Medartuum AB 14/11/2011 30 mg Film-coated tablet 28 EU/1/04/292/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands

Sweden 14/11/2011

Mimpara Paranova Danmark AS


Denmark 18/07/2011



Denmark 18/07/2011



Denmark 18/07/2011

Mimpara Paranova Läkemedel AB


Sweden 07/11/2011

Mimpara Paranova Läkemedel AB


Sweden 07/11/2011

Mimpara Pharmachim AB

10/06/2011 30 mg Film-coated tablet 28 EU/1/04/292/002 Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 21/06/2011




Sweden 21/06/2011



Sweden 21/06/2011

Mirapexin 2 Care 4 17/12/2010 0.52 mg Prolonged-release tablet

100 EU/1/97/051/018 Austria, Belgium, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 11/02/2011



Denmark 11/02/2011



Denmark 11/02/2011

Mirapexin 2 Care 4 08/02/2011 0.18 mg Tablet 30 EU/1/97/051/003 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 04/03/2011

Mirapexin 2 Care 4 08/02/2011 0.18 mg Tablet 100 EU/1/97/051/004 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 04/03/2011

Mirapexin 2 Care 4 08/02/2011 0.7 mg Tablet 100 EU/1/97/051/006 Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 29/03/2011




Denmark 28/03/2011

Mirapexin Axicorp Pharma GmbH


30 EU/1/97/051/020 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/05/2011




Germany 03/05/2011




Germany 03/05/2011




Germany 03/05/2011

Mirapexin B2B Medical GmbH



Germany 15/03/2011




Germany 11/03/2011




Germany 15/03/2011




Germany 11/03/2011




Germany 15/03/2011




100 EU/1/97/051/018 Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/03/2011




Germany 15/03/2011




Germany 15/03/2011

Mirapexin BR Pharma International Ltd


30 EU/1/97/051/020 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands


10/05/2011





10/05/2011





06/05/2011

Mirapexin Chemilines Ltd 06/01/2011 0.26 mg Prolonged-release tablet

10 EU/1/97/051/013 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands

United Kingdom

08/04/2011



United Kingdom

08/04/2011



United Kingdom

11/04/2011



United Kingdom

11/04/2011



United Kingdom

15/04/2011



United Kingdom

15/04/2011





04/07/2011




10/10/2011

Mirapexin Cross Healthcare Ltd




15/02/2011





15/02/2011





15/02/2011





15/02/2011





16/02/2011





15/02/2011





16/02/2011

Mirapexin Doncaster Pharmaceuticals Group Ltd


30 EU/1/97/051/023 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


03/01/2011


Mirapexin Doncaster Pharmaceuticals Group Ltd


30 EU/1/97/051/014 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


07/07/2011

Mirapexin Ebb Medical AB

04/10/2011 0.18 mg Tablet 30 EU/1/97/051/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 08/11/2011



Sweden 08/11/2011



Sweden 08/11/2011

Mirapexin Emra-Med 10/02/2011 2.1 mg Prolonged-release tablet

100 EU/1/97/051/024 Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/03/2011

Mirapexin Emra-Med 10/02/2011 3.15 mg Prolonged-release tablet

100 EU/1/97/051/027 Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/03/2011

Mirapexin G-Pharma Ltd 25/02/2011 0.26 mg Prolonged-release tablet


United Kingdom

14/03/2011


Mirapexin Interport Ltd 08/08/2011 0.52 mg Prolonged-release tablet

10 EU/1/97/051/016 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands

United Kingdom

24/10/2011



United Kingdom

24/10/2011



United Kingdom

24/10/2011



United Kingdom

24/10/2011

Mirapexin Kohlpharma GmbH


10 EU/1/97/051/013 Italy Germany 26/04/2011

Mirapexin Kosei Pharma UK Limited


10 EU/1/97/051/013 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


25/07/2011





25/07/2011






25/07/2011





25/07/2011





25/07/2011





25/07/2011





25/07/2011

Mirapexin Lexon (UK) Ltd




19/12/2011






19/12/2011





19/12/2011





19/12/2011





19/12/2011

Mirapexin Medartuum AB 17/02/2011 0.7 mg Tablet 100 EU/1/97/051/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 21/02/2011

Mirapexin Medartuum AB 18/02/2011 0.26 mg Prolonged-release tablet


Sweden 22/02/2011




Sweden 02/03/2011



Sweden 02/03/2011

Mirapexin Medartuum AB 01/04/2011 0.18 mg Tablet 100 EU/1/97/051/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 06/04/2011

Mirapexin Medcor Pharmaceuticals BV



The Netherlands

03/05/2011




The Netherlands

03/05/2011




The Netherlands

03/05/2011




The Netherlands

10/11/2011

Mirapexin Mediwin Ltd 08/06/2011 0.52 mg Prolonged-release tablet

10 EU/1/97/051/016 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

20/06/2011




United Kingdom

14/07/2011



United Kingdom

14/07/2011



United Kingdom

05/09/2011

Mirapexin MPT Pharma 24/01/2011 0.088 mg Tablet 30 EU/1/97/051/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


10/02/2011

Mirapexin Orifarm AB 14/10/2011 0.52 mg Prolonged-release tablet

100 EU/1/97/051/018 Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 28/10/2011



Sweden 28/10/2011



Sweden 28/10/2011

Mirapexin Swingward Ltd TA Medihealth


30 EU/1/97/051/017 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

02/03/2011




30 EU/1/97/051/014 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

30/05/2011


12/12/2011 0.088 mg Tablet 30 EU/1/97/051/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands

United Kingdom

21/12/2011

Mircera CC Pharma 17/01/2011 50 µg/0.3 ml Solution for injection

3 x 1 pre-filled syringe

EU/1/07/400/023 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Latvia, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/01/2011

Mircera CC Pharma 21/03/2011 75 µg/0.3 ml Solution for injection


EU/1/07/400/024 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Latvia, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/04/2011

Mircera Dr Fisher Farma BV

28/10/2011 100 µg/0.3 ml Solution for injection


EU/1/07/400/010 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, United Kingdom

The Netherlands

15/11/2011





The Netherlands

15/11/2011





The Netherlands

15/11/2011

Mircera Emra-Med 06/07/2011 100 µg/0.3 ml Solution for injection



Germany 22/07/2011




Germany 22/07/2011





Germany 22/07/2011




Germany 22/07/2011




Germany 22/07/2011




Germany 22/07/2011




Germany 22/07/2011




Germany 22/07/2011

Mircera Kohlpharma GmbH



EU/1/07/400/023 Greece, Spain Germany 24/11/2011

Mircera Kohlpharma GmbH



EU/1/07/400/024 Greece, Spain Germany 23/11/2011

Mircera Medcor Pharmaceuticals BV



EU/1/07/400/010 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

04/08/2011





The Netherlands

04/08/2011






The Netherlands

04/08/2011

Mircera Orifarm AB 04/03/2011 100 µg/0.3 ml Solution for injection



Sweden 21/03/2011



EU/1/07/400/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 21/03/2011




Sweden 21/03/2011

Mircera Orifarm AS 04/03/2011 100 µg/0.3 ml Solution for injection



Denmark 23/03/2011




Denmark 31/03/2011




Denmark 23/08/2011

Mircera Pharma Westen GmbH




Germany 25/11/2011





Germany 25/11/2011






Germany 25/11/2011





Germany 24/11/2011





Germany 25/11/2011





Germany 24/11/2011





Germany 25/11/2011





Germany 25/11/2011

Mozobil Orifarm AB 10/05/2011 20 mg/ml Solution for injection


Sweden 12/05/2011

MULTAQ Doncaster Pharmaceuticals Group Ltd



03/03/2011

MULTAQ G-Pharma Ltd 09/03/2011 400 mg Film-coated tablet 60 EU/1/09/591/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


29/03/2011

MULTAQ Orifarm AB 17/10/2011 400 mg Film-coated tablet 20 EU/1/09/591/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 08/11/2011


MULTAQ Swingward Ltd TA Medihealth


United Kingdom

08/07/2011

MULTAQ Waymade PLC 11/01/2011 400 mg Film-coated tablet 60 EU/1/09/591/003 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


17/01/2011

Neoclarityn Autumn Healthcare Ltd

23/05/2011 5 mg Film-coated tablet 30 EU/1/00/161/011 Ireland, United Kingdom Ireland, United Kingdom

14/06/2011

Neoclarityn Dr Fisher Farma BV


The Netherlands

14/11/2011

Neoclarityn Imed Healthcare Ltd

06/07/2011 5 mg Film-coated tablet 30 EU/1/00/161/011 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


28/07/2011

Neoclarityn PCO Manufacturing

16/06/2011 0.5 mg/ml Oral solution 1 bottle EU/1/00/161/062 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


14/07/2011

NeoRecormon Abacus Medicine A/S

21/06/2011 10000 IU Solution for injection


EU/1/97/031/036 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 29/06/2011




EU/1/97/031/036 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands

Sweden 05/07/2011





Denmark 29/06/2011




EU/1/97/031/042 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 05/07/2011






Denmark 29/06/2011





Sweden 19/10/2011

NeoRecormon Haemato Pharm AG




Denmark 19/05/2011





Denmark 19/05/2011





Denmark 19/05/2011





Denmark 19/05/2011





Denmark 19/05/2011


Neulasta ABACUS MEDICINE A/S




Sweden 22/09/2011

Neulasta Beragena Arzneimittel GmbH




Germany 29/06/2011

Neulasta CC Pharma 07/06/2011 6 mg Solution for injection


EU/1/02/227/004 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/06/2011

Neulasta Dr Fisher Farma BV



EU/1/02/227/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, United Kingdom

The Netherlands

10/05/2011

Neulasta Emra-Med 22/03/2011 6 mg Solution for injection



Austria, Germany

18/04/2011

Neulasta Haemato Pharm AG




Austria, Germany

31/01/2011





Denmark 18/05/2011






Denmark 18/05/2011

Neulasta Inopha GmbH 03/02/2011 6 mg Solution for injection


EU/1/02/227/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

16/02/2011

Neulasta Inopha GmbH 26/09/2011 6 mg Solution for injection



Sweden 11/10/2011

Neulasta MedicoPharm AG



EU/1/02/227/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

20/04/2011

Neulasta mibe GmbH Arzneimittel



EU/1/02/227/001 Greece Germany 28/06/2011

Neulasta NewNeopharm BV


1 pre-filled syringe (non blister)

EU/1/02/227/002 Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 24/03/2011

Neulasta NewNeopharm BV



EU/1/02/227/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 05/07/2011


Neulasta Omnia Läkemedel AB



EU/1/02/227/004 Austria, Belgium, Bulgaria, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 20/12/2011

Neulasta Orifarm AB 04/10/2011 6 mg Solution for injection



Sweden 04/11/2011

Neulasta Oy Cross Pharma AB



EU/1/02/227/001 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Finland 15/03/2011

Neulasta Paranova Läkemedel AB




Sweden 20/06/2011

Neulasta Paranova OY 31/08/2011 6 mg Solution for injection



Finland 07/09/2011

Neulasta Paranova OY 26/10/2011 6 mg Solution for injection



Finland 14/11/2011

Neulasta Parx AB 11/07/2011 6 mg Solution for injection


EU/1/02/227/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, United Kingdom

Sweden 04/11/2011

Neulasta Pharmachim AB



EU/1/02/227/004 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 18/10/2011


Neulasta Propharmed GmbH



EU/1/02/227/001 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/04/2011

Neulasta Tabsn Caps Pack ApS



EU/1/02/227/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 06/07/2011

Neulasta Veron Pharma Vertriebs GmbH




Neulasta Veron Pharma Vertriebs GmbH



EU/1/02/227/001 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 17/05/2011

Neupro Amimed Direct Ltd

13/07/2010 2 mg/24h Transdermal patch 7 patches EU/1/05/331/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


12/05/2011




12/05/2011




12/05/2011




12/05/2011




12/05/2011




12/05/2011

Neupro Doncaster Pharmaceuticals Group Ltd

25/02/2011 2 mg/24h Transdermal patch 28 patches EU/1/05/331/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


04/04/2011





04/04/2011




04/04/2011




04/04/2011

Neupro EuroPharma DK

02/02/2011 4 mg/24h Transdermal patch 7 patches EU/1/05/331/004 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/02/2011



Denmark 16/02/2011


15/02/2011 8 mg/24h Transdermal patch 7 patches EU/1/05/331/010 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 16/02/2011


15/02/2011 8 mg/24h Transdermal patch 28 patches EU/1/05/331/011 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 16/02/2011



Denmark 11/11/2011



Denmark 11/11/2011




Denmark 11/11/2011



Denmark 11/11/2011

Neupro Medcor Pharmaceuticals BV

20/06/2011 6 mg/24h Transdermal patch 28 patches EU/1/05/331/008 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/06/2011

Neupro Medcor Pharmaceuticals BV

20/06/2011 8 mg/24h Transdermal patch 28 patches EU/1/05/331/011 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/06/2011

Neupro MTK Pharma GmbH

10/03/2011 4 mg/24h Transdermal patch 84 patches EU/1/05/331/024 Austria, Czech Republic, Italy, Spain, The Netherlands, United Kingdom

Germany 12/04/2011



Germany 12/04/2011



Germany 12/04/2011


07/11/2011 2 mg/24h Transdermal patch 84 patches EU/1/05/331/018 Austria, Czech Republic, France, Italy, Spain, The Netherlands, United Kingdom

Germany 14/11/2011

Neupro PCO Manufacturing

20/06/2011 8 mg/24h Transdermal patch 28 patches EU/1/05/331/011 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands


22/06/2011

Neupro Pharma Westen GmbH

04/10/2011 2 mg/24h Transdermal patch 56 patches EU/1/05/331/016 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 20/12/2011



Germany 20/12/2011




Germany 20/12/2011

Neupro Waymade PLC 04/10/2011 6 mg/24h Transdermal patch 28 patches EU/1/05/331/008 Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


11/10/2011

NeuroBloc CC Pharma 24/02/2011 5000 U/ml Solution for injection


Germany 07/03/2011



Germany 22/07/2011



Germany 23/09/2011

Nevanac Euro Registratie Collectief BV


1 bottle EU/1/07/433/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

28/06/2011

Nexavar Axicorp Pharma GmbH

20/06/2011 200 mg Film-coated tablet 112 EU/1/06/342/001 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/07/2011

Nexavar Haemato Pharm AG

11/03/2011 200 mg Film-coated tablet 112 EU/1/06/342/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

Denmark 29/03/2011

Nexavar Omnia Läkemedel AB

07/06/2011 200 mg Film-coated tablet 112 EU/1/06/342/001 Bulgaria, France, Greece, Italy, Lithuania, Poland, Romania, Spain, United Kingdom

Sweden 17/06/2011

Nexavar Orifarm AB 12/05/2011 200 mg Film-coated tablet 112 EU/1/06/342/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 25/05/2011


Nexavar Pharma Westen GmbH

30/09/2010 200 mg Film-coated tablet 112 EU/1/06/342/001 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/06/2011

Norvir CC Pharma 03/01/2011 100 mg Film-coated tablet 30 EU/1/96/016/005 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/01/2011

Norvir CC Pharma 28/04/2011 100 mg Film-coated tablet 90 (3 x 30) EU/1/96/016/007 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 11/05/2011

Norvir Pharma Westen GmbH

27/04/2011 100 mg Film-coated tablet 90 (3 x 30) EU/1/96/016/007 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/05/2011

NovoMix 30 FlexPen

EU-Pharma BV 24/05/2011 100 U/ml Suspension for injection

5 pre-filled pens

EU/1/00/142/009 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

10/08/2011

NovoMix 50 FlexPen

Euro Registratie Collectief BV


5 pre-filled pens


The Netherlands

11/02/2011

NovoNorm BB Farma s.r.l.

17/11/2011 0.5 mg Tablet 120 EU/1/98/076/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/12/2011

NovoNorm CC Pharma 17/10/2011 0.5 mg Tablet 120 EU/1/98/076/006 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011

NovoNorm CC Pharma 17/10/2011 1 mg Tablet 120 EU/1/98/076/013 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011

NovoNorm CC Pharma 17/10/2011 2 mg Tablet 120 EU/1/98/076/020 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011

NovoNorm Euro Registratie Collectief BV

12/07/2011 0.5 mg Tablet 90 EU/1/98/076/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

13/07/2011


NovoNorm Euro Registratie Collectief BV

12/07/2011 1 mg Tablet 90 EU/1/98/076/012 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

13/07/2011

NovoRapid Axicorp Pharma GmbH


5 x (1 x 10 ml) vials

EU/1/99/119/015 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/10/2011

NovoRapid CC Pharma 19/04/2011 100 U/ml Solution for injection

10 cartridges


Germany 29/04/2011

NovoRapid Emra-Med 25/01/2010 100 U/ml Solution for injection

5 x (1 x 10 ml) vials


Germany 12/01/2011

NovoRapid EU-Pharma BV 30/05/2011 100 U/ml Solution for injection

5 pre-filled pens

EU/1/99/119/009 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

28/06/2011

NovoRapid PCO Manufacturing


1 vial EU/1/99/119/001 United Kingdom Ireland 08/12/2011

Noxafil Euro Registratie Collectief BV

13/12/2010 40 mg/ml Oral suspension 1 bottle EU/1/05/320/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

06/01/2011

Noxafil Orifarm AB 19/05/2011 40 mg/ml Oral suspension 1 bottle EU/1/05/320/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 23/05/2011

Noxafil Orifarm AS 11/05/2011 40 mg/ml Oral suspension 1 bottle EU/1/05/320/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 25/05/2011

Noxafil Propharmed GmbH

31/03/2011 40 mg/ml Oral suspension 1 bottle EU/1/05/320/001 Austria, Belgium, Bulgaria, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 20/04/2011

NutropinAq Dr Fisher Farma BV


1 cartridge EU/1/00/164/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

27/07/2011


Olanzapine Mylan Doncaster Pharmaceuticals Group Ltd

06/10/2011 2.5 mg Film-coated tablet 28 EU/1/08/475/001 Ireland, Malta, United Kingdom Ireland, Malta, United Kingdom

18/10/2011


07/10/2011 10 mg Film-coated tablet 28 EU/1/08/475/019 Ireland, Malta, United Kingdom Ireland, Malta, United Kingdom

18/10/2011


07/10/2011 5 mg Film-coated tablet 28 EU/1/08/475/007 Ireland, Malta, United Kingdom Ireland, Malta, United Kingdom

18/10/2011

Omnitrope Concept Pharma Vertriebs GmbH

07/06/2011 3.3 mg/ml Solution for injection in cartridge

1 cartridge EU/1/06/332/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/07/2011

Omnitrope Concept Pharma Vertriebs GmbH


1 cartridge EU/1/06/332/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/07/2011

Omnitrope Medartuum AB 13/01/2011 6.7 mg/ml Solution for injection in cartridge

1 cartridge EU/1/06/332/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 17/02/2011

Omnitrope MTK Pharma GmbH


10 cartridges

EU/1/06/332/006 France, Italy Germany 25/02/2011

Omnitrope MTK Pharma GmbH


10 cartridges

EU/1/06/332/009 Austria, France, Italy Germany 25/02/2011

Omnitrope Pharmachim AB


1 cartridge EU/1/06/332/004 Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 12/07/2011

Omnitrope Pharmachim AB


1 cartridge EU/1/06/332/007 Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 12/07/2011

Onbrez Breezhaler 2 Care 4 18/05/2011 150 µg Inhalation powder, hard capsule



Denmark 24/05/2011



30 (3 x 10) + 1 inhaler


Denmark 24/05/2011




Denmark 24/05/2011

Onbrez Breezhaler Amimed Direct Ltd


30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


29/06/2011

Onbrez Breezhaler Amimed Direct Ltd


30 (3 x 10) + 1 inhaler

EU/1/09/593/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


29/06/2011

Onbrez Breezhaler Axicorp Pharma GmbH




Germany 14/03/2011

Onbrez Breezhaler Axicorp Pharma GmbH




Germany 29/03/2011

Onbrez Breezhaler B&S Healthcare Ltd


30 (3 x 10) + 1 inhaler



12/09/2011

Onbrez Breezhaler B&S Healthcare Ltd


30 (3 x 10) + 1 inhaler



12/09/2011

Onbrez Breezhaler B2B Medical GmbH


30 (3 x 10) + 1 inhaler


Germany 23/08/2011


Onbrez Breezhaler B2B Medical GmbH




Germany 23/08/2011

Onbrez Breezhaler Beragena Arzneimittel GmbH


30 (3 x 10) + 1 inhaler


Germany 05/05/2011

Onbrez Breezhaler Beragena Arzneimittel GmbH




Germany 05/05/2011

Onbrez Breezhaler BR Pharma International Ltd


30 (3 x 10) + 1 inhaler


Germany 28/02/2011

Onbrez Breezhaler BR Pharma International Ltd




Germany 02/08/2011

Onbrez Breezhaler CC Pharma 14/12/2010 150 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Austria, Belgium, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/01/2011




Germany 12/01/2011


30 (3 x 10) + 1 inhaler


Germany 29/03/2011



EU/1/09/593/009 Austria, Belgium, Denmark, Finland, France, Greece, Hungary, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/04/2011

Onbrez Breezhaler Dr Fisher Farma BV


30 (3 x 10) + 1 inhaler


The Netherlands

30/05/2011




30 (3 x 10) + 1 inhaler


The Netherlands

20/07/2011



10 + 1 inhaler


The Netherlands

24/08/2011



10 + 1 inhaler


The Netherlands

24/08/2011

Onbrez Breezhaler Emra-Med 21/09/2011 300 µg Inhalation powder, hard capsule


EU/1/09/593/009 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, TheNetherlands, United Kingdom

Germany 20/10/2011

Onbrez Breezhaler Emra-Med 25/11/2011 150 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler


Germany 30/11/2011

Onbrez Breezhaler Euro Registratie Collectief BV


30 (3 x 10) + 1 inhaler


The Netherlands

04/01/2011

Onbrez Breezhaler EuroPharma DK



EU/1/09/593/004 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 30/08/2011



30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 30/08/2011



30 (3 x 10) + 1 inhaler


Denmark 30/08/2011






Denmark 30/08/2011

Onbrez Breezhaler Interport Ltd 04/11/2011 150 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands

United Kingdom

14/11/2011

Onbrez Breezhaler Interport Ltd 04/11/2011 300 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler

EU/1/09/593/007 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands

United Kingdom

09/11/2011

Onbrez Breezhaler Kohlpharma GmbH


30 (3 x 10) + 1 inhaler

EU/1/09/593/007 Italy, Spain Germany 25/01/2011




EU/1/09/593/009 Austria, France, Ireland, Italy, Spain Germany 23/03/2011




EU/1/09/593/004 Italy, Norway, United Kingdom Germany 04/05/2011



30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Italy Germany 04/05/2011

Onbrez Breezhaler Medcor Pharmaceuticals BV


30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

18/03/2011

Onbrez Breezhaler Medcor Pharmaceuticals BV


30 (3 x 10) + 1 inhaler


The Netherlands

18/03/2011

Onbrez Breezhaler MedicoPharm AG




Germany 08/03/2011




30 (3 x 10) + 1 inhaler


Germany 08/03/2011





Germany 08/03/2011



30 (3 x 10) + 1 inhaler


Germany 11/03/2011

Onbrez Breezhaler Mediwin Ltd 10/02/2011 150 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands

United Kingdom

23/02/2011

Onbrez Breezhaler Mediwin Ltd 24/03/2011 300 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler

EU/1/09/593/007 Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands

United Kingdom

01/04/2011

Onbrez Breezhaler MPT Pharma 04/01/2011 150 µg Inhalation powder, hard capsule




10/01/2011


30 (3 x 10) + 1 inhaler



07/01/2011


30 (3 x 10) + 1 inhaler



03/02/2011






03/02/2011

Onbrez Breezhaler Orifarm AS 28/01/2011 150 µg Inhalation powder, hard capsule

30 (3 x 10) + 1 inhaler


Denmark 15/03/2011

Onbrez Breezhaler Orifarm AS 28/01/2011 150 µg Inhalation powder, hard capsule



Denmark 15/03/2011

Onbrez Breezhaler Paranova Danmark AS


30 (3 x 10) + 1 inhaler

EU/1/09/593/002 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Romania, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 07/10/2011




EU/1/09/593/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 07/10/2011




EU/1/09/593/009 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 07/10/2011



30 (3 x 10) + 1 inhaler

EU/1/09/593/007 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Romania, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 07/10/2011

Onglyza Lexon (UK) Ltd



20/12/2011


Onglyza Orifarm AS 27/10/2011 5 mg Film-coated tablet 28 EU/1/09/545/006 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/11/2011

Onglyza Paranova Danmark AS


Denmark 12/10/2011

Onglyza Paranova Danmark AS


Denmark 12/10/2011

Onglyza PCO Manufacturing



06/06/2011

Onglyza PCO Manufacturing

24/03/2011 5 mg Film-coated tablet 28 EU/1/09/545/006 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


22/07/2011

Onglyza Swingward Ltd TA Medihealth

15/03/2011 5 mg Film-coated tablet 28 EU/1/09/545/006 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

28/04/2011

Onglyza Waymade PLC 14/07/2011 5 mg Film-coated tablet 28 EU/1/09/545/006 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


01/08/2011

Opatanol B&S Healthcare Ltd

16/11/2011 1 mg/ml Eye drops, solution 1 bottle EU/1/02/217/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


07/12/2011

Opatanol Clear Pharmacy

20/12/2010 1 mg/ml Eye drops, solution 1 bottle EU/1/02/217/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


11/01/2011


Opatanol Dr Fisher Farma BV

13/07/2011 1 mg/ml Eye drops, solution 1 bottle EU/1/02/217/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

03/08/2011

Opatanol Lexon (UK) Ltd

13/12/2011 1 mg/ml Eye drops, solution 1 bottle EU/1/02/217/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


20/12/2011

Opatanol Paranova Läkemedel AB

02/08/2011 1 mg/ml Eye drops, solution 1 bottle EU/1/02/217/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 23/08/2011

Opatanol Paranova Läkemedel AB

02/08/2011 1 mg/ml Eye drops, solution 3 bottles EU/1/02/217/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 23/08/2011

Opatanol Profind Wholesale Ltd.

12/10/2011 1 mg/ml Eye drops, solution 1 bottle EU/1/02/217/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


13/12/2011

Optruma Mediwin Ltd 28/11/2011 60 mg Film-coated tablet 28 EU/1/98/074/002 Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

France 07/12/2011

Optruma Mediwin Ltd 28/11/2011 60 mg Film-coated tablet 84 EU/1/98/074/003 Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Poland, Spain, Sweden, The Netherlands, United Kingdom

France 07/12/2011


Orencia Medartuum AB 24/05/2011 250 mg Powder for concentrate for solution for infusion

1 vial + 1 syringe

EU/1/07/389/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 31/05/2011

Orencia Orifarm AB 31/01/2011 250 mg Powder for concentrate for solution for infusion

1 vial + 1 syringe

EU/1/07/389/001 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 17/03/2011

Orencia Pharmachim AB


1 vial + 1 syringe


Sweden 22/11/2011

Orencia Pharmachim AB


3 vials + 3 syringes


Sweden 22/11/2011

Orfadin Abacus Medicine A/S

30/06/2011 10 mg Capsule, hard 60 EU/1/04/303/003 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 11/07/2011



Denmark 11/07/2011



Denmark 12/08/2011

Orgalutran Orifarm AB 30/06/2011 0.25 mg/ 0.5 ml



EU/1/00/130/002 Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/07/2011

Orgalutran Orifarm AS 30/06/2011 0.25 mg/ 0.5 ml



EU/1/00/130/001 Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 04/07/2011

Orgalutran Orifarm AS 30/06/2011 0.25 mg/ 0.5 ml



EU/1/00/130/002 Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 04/07/2011


Orgalutran Pharmachim AB

08/07/2011 0.25 mg/ 0.5 ml




Sweden 19/07/2011

Oslif Breezhaler BR Pharma International Ltd


30 (3 x 10) + 1 inhaler


Germany 14/04/2011

Oslif Breezhaler BR Pharma International Ltd




Germany 02/08/2011

Oslif Breezhaler Pharma Westen GmbH


30 (3 x 10) + 1 inhaler


Germany 04/03/2011





Germany 04/03/2011



30 (3 x 10) + 1 inhaler


Germany 07/03/2011





Germany 07/03/2011

Ovitrelle Orifarm AB 27/10/2011 250 micrograms/ 0.5 ml




Sweden 10/11/2011

Ovitrelle Orifarm AS 27/10/2011 250 micrograms/ 0.5 ml




Denmark 10/11/2011

Pegasys Axicorp Pharma GmbH


4 pre-filled syringes + 4 injection needles


Germany 22/08/2011


Pegasys Medartuum AB 07/04/2011 135 µg Solution for injection



Sweden 15/04/2011

Pegasys Omnia Läkemedel AB



EU/1/02/221/006 Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Latvia, Lithuania, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 20/10/2011

Pegasys Omnia Läkemedel AB



EU/1/02/221/008 Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Latvia, Lithuania, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 20/10/2011

Pegasys Orifarm AB 20/10/2011 180 µg Solution for injection



Sweden 07/12/2011

Pegasys Orifarm AS 04/01/2011 180 µg Solution for injection



Denmark 07/01/2011

Pegasys Veron Pharma Vertriebs GmbH


1 pre-filled syringe + 1 injection needle

EU/1/02/221/007 Austria, Greece Germany 28/11/2011

Pegasys Veron Pharma Vertriebs GmbH



EU/1/02/221/008 Austria, Greece Germany 28/11/2011

PegIntron Emra-Med 06/06/2007 100 micrograms

Powder and solvent for solution for injection in pre-filled pen

4 pens + 4 injection needles + 8 cleansing swabs


Germany 11/10/2011


PegIntron Orifarm AS 07/01/2011 120 micrograms




Denmark 12/01/2011

PegIntron Propharmed GmbH

19/04/2011 100 micrograms




Germany 29/04/2011






Germany 29/04/2011






Germany 29/04/2011






Germany 29/04/2011






Germany 29/04/2011

Plavix 2 Care 4 27/06/2011 300 mg Film-coated tablet 30 x 1 EU/1/98/069/009 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 12/08/2011

Plavix Acta Pharma 29/07/2011 75 mg Film-coated tablet 28 EU/1/98/069/001a Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Bulgaria 26/08/2011


Plavix AN Pharmacy Sp. z o.o.

17/12/2010 75 mg Film-coated tablet 28 EU/1/98/069/001a Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 17/03/2011

Plavix BB Farma s.r.l.

22/03/2011 75 mg Film-coated tablet 28 EU/1/98/069/001a Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

France 14/04/2011

Plavix Combiphar Europe BV

05/02/2009 75 mg Film-coated tablet 30 EU/1/98/069/005a Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

05/07/2011

Plavix Delfarma SpZoo

02/03/2011 75 mg Film-coated tablet 28 EU/1/98/069/001a Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 16/03/2011

Plavix Lexon (UK) Ltd

31/03/2011 75 mg Film-coated tablet 30 EU/1/98/069/005a Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


12/05/2011

Plavix Mediwin Ltd 07/01/2011 75 mg Film-coated tablet 30 EU/1/98/069/005a Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

France 15/02/2011

Plavix PHARMECO ApS

06/04/2011 75 mg Film-coated tablet 28 EU/1/98/069/001a Czech Republic, Italy, Lithuania, Romania, Spain

Denmark 18/04/2011

Plavix PI-Pharma N.V.

11/10/2010 75 mg Film-coated tablet 28 EU/1/98/069/001a Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Belgium 13/12/2011


Plavix PI-Pharma N.V.

11/08/2011 75 mg Film-coated tablet 84 EU/1/98/069/003a Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Belgium 13/12/2011

Plavix SAIMA Productos Y Servicios S.L.U.

07/06/2011 75 mg Film-coated tablet 28 EU/1/98/069/001a Germany Spain 23/08/2011

Pradaxa Axicorp Pharma GmbH

06/05/2011 110 mg Capsule, hard 30 x 1 EU/1/08/442/006 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 21/06/2011

Pradaxa Axicorp Pharma GmbH

06/05/2011 75 mg Capsule, hard 30 x 1 EU/1/08/442/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 21/06/2011

Pradaxa Emra-Med 26/09/2011 110 mg Capsule, hard 60 x 1 EU/1/08/442/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/10/2011

Pradaxa Euro Registratie Collectief BV

30/05/2011 75 mg Capsule, hard 30 x 1 EU/1/08/442/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

27/06/2011



The Netherlands

20/09/2011



The Netherlands

20/09/2011



The Netherlands

21/09/2011

Pradaxa Europharma Sverige AB

25/10/2011 110 mg Capsule, hard 60 x 1 EU/1/08/442/007 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/12/2011


Pradaxa Europharma Sverige AB

25/10/2011 75 mg Capsule, hard 60 x 1 EU/1/08/442/003 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 12/12/2011

Pradaxa Medartuum AB 26/10/2011 110 mg Capsule, hard 60 x 1 EU/1/08/442/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 28/10/2011

Pradaxa Orifarm AB 20/10/2011 110 mg Capsule, hard 60 x 1 EU/1/08/442/007 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Spain, The Netherlands, United Kingdom

Sweden 25/11/2011

Pradaxa Orifarm AB 20/10/2011 75 mg Capsule, hard 60 x 1 EU/1/08/442/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 25/11/2011

Pradaxa Orifarm AS 07/10/2011 110 mg Capsule, hard 60 x 1 EU/1/08/442/007 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 18/11/2011

Pradaxa Orifarm AS 07/10/2011 75 mg Capsule, hard 60 x 1 EU/1/08/442/003 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 18/11/2011

Pradaxa PCO Manufacturing

15/06/2011 110 mg Capsule, hard 60 x 1 EU/1/08/442/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands


09/08/2011

Pradaxa PCO Manufacturing

15/06/2011 75 mg Capsule, hard 60 x 1 EU/1/08/442/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands


09/08/2011

Pradaxa Pharma Westen GmbH

11/03/2011 110 mg Capsule, hard 30 x 1 EU/1/08/442/006 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/03/2011


Pradaxa Pharma Westen GmbH

25/08/2011 110 mg Capsule, hard 60 x 1 EU/1/08/442/007 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/09/2011

Pradaxa Veron Pharma Vertriebs GmbH

31/03/2011 110 mg Capsule, hard 10 x 1 EU/1/08/442/005 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 17/05/2011



Germany 17/05/2011



Germany 17/05/2011



Germany 17/05/2011



Germany 11/10/2011

Prandin Paranova Läkemedel AB

08/04/2011 1 mg Tablet 90 EU/1/00/162/010 Spain, United Kingdom Sweden 20/04/2011







Prevenar 13 Axicorp Pharma GmbH

07/12/2010 0.5ml Suspension for injection

1 pre-filled syringe with separate needle


Germany 11/01/2011

Prevenar 13 CC Pharma 20/12/2010 - - Suspension for injection



Germany 14/01/2011

Prezista Medcor Pharmaceuticals BV


The Netherlands

16/05/2011


Prezista Orifarm AS 16/12/2010 600 mg Film-coated tablet 60 EU/1/06/380/002 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/01/2011

Prezista Orifarm OY 07/03/2011 400 mg Film-coated tablet 60 EU/1/06/380/003 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Finland 28/03/2011

Pritor BCN Farma SL 01/02/2011 40 mg Tablet 28 EU/1/98/089/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, The Netherlands, United Kingdom

Spain 15/02/2011

Pritor BCN Farma SL 23/03/2011 80 mg Tablet 28 EU/1/98/089/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, The Netherlands, United Kingdom

Spain 01/04/2011

Pritor Emra-Med 28/07/2011 40 mg Tablet 98 EU/1/98/089/004 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/09/2011

Pritor Emra-Med 28/07/2011 80 mg Tablet 98 EU/1/98/089/009 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/09/2011

Pritor Euromedicines, S.L.

13/12/2010 80 mg Tablet 28 EU/1/98/089/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, The Netherlands, United Kingdom

Spain 28/02/2011


PritorPlus B&S Healthcare Ltd

12/05/2011 80 mg/ 12.5 mg

Tablet 28 EU/1/02/215/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


11/07/2011

PritorPlus B&S Healthcare Ltd

12/05/2011 80 mg/ 25mg

Tablet 28 EU/1/02/215/016 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


11/07/2011

PritorPlus Emra-Med 26/07/2011 80 mg/ 12.5 mg

Tablet 98 EU/1/02/215/010 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/09/2011

PritorPlus Emra-Med 28/07/2011 80 mg/ 25mg


Germany 09/09/2011

PritorPlus Emra-Med 30/09/2011 40 mg/ 12.5 mg


Germany 11/10/2011

PritorPlus Euromedicines, S.L.

13/12/2010 80 mg/ 12.5 mg

Tablet 28 EU/1/02/215/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, The Netherlands, United Kingdom

Spain 28/02/2011

PritorPlus G-Pharma Ltd 02/02/2011 80 mg/ 12.5 mg

Tablet 28 EU/1/02/215/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


17/02/2011


PritorPlus G-Pharma Ltd 02/02/2011 80 mg/ 25mg

Tablet 28 EU/1/02/215/016 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


17/02/2011

PritorPlus Orifarm AB 08/03/2011 80 mg/ 12.5 mg

Tablet 98 EU/1/02/215/010 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 17/03/2011

Privigen Axicorp Pharma B.V.



Germany 01/08/2011

Privigen Emra-Med 27/10/2011 100 mg/ml Solution for infusion


Germany 17/11/2011

Privigen Haemato Pharm AG


1 vial EU/1/08/446/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/08/2011




Germany 15/08/2011




Germany 15/08/2011

Procoralan Autumn Healthcare Ltd

05/07/2011 5 mg Film-coated tablet 56 EU/1/05/316/003 Ireland, United Kingdom Ireland, United Kingdom

11/07/2011

Procoralan Autumn Healthcare Ltd

05/07/2011 7.5 mg Film-coated tablet 56 EU/1/05/316/010 Ireland, United Kingdom Ireland, United Kingdom

11/07/2011


Procoralan Lexon (UK) Ltd



21/12/2011

Procoralan PCO Manufacturing

11/05/2010 5 mg Film-coated tablet 56 EU/1/05/316/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


10/02/2011

Procoralan Profind Wholesale Ltd.

17/08/2011 5 mg Film-coated tablet 56 EU/1/05/316/003 United Kingdom Ireland 25/08/2011

Procoralan Profind Wholesale Ltd.

17/08/2011 7.5 mg Film-coated tablet 56 EU/1/05/316/010 United Kingdom Ireland 25/08/2011

Prolia Axicorp Pharma GmbH


1 pre-filled syringe with automatic needle guard (blistered)

EU/1/10/618/003 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/02/2011

Prolia CC Pharma 02/12/2010 60 mg/ml Solution for injection


EU/1/10/618/003 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/01/2011

Prolia Eureco-Pharma B.V.



EU/1/10/618/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, United Kingdom

The Netherlands

30/08/2011

Prolia Euro Registratie Collectief BV




The Netherlands

22/11/2011


Prolia Medcor Pharmaceuticals BV 0



EU/1/10/618/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

21/06/2011

Prolia Pharma Westen GmbH




Germany 15/11/2011

Prometax B&S Healthcare Ltd

17/05/2011 1.5 mg Capsule, hard 28 EU/1/98/092/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


31/05/2011




31/05/2011


17/05/2011 4.5 mg Capsule, hard 56 EU/1/98/092/008 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


31/05/2011


17/05/2011 4.6 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/092/020 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


31/05/2011





31/05/2011


17/05/2011 9.5 mg / 24 hours

Transdermal patch 30 sachets EU/1/98/092/024 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


31/05/2011

Prometax Emra-Med 24/05/2011 3 mg Capsule, hard 56 EU/1/98/092/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/05/2011

Prometax Emra-Med 24/05/2011 4.5 mg Capsule, hard 56 EU/1/98/092/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/05/2011

Protelos 2 Care 4 17/05/2010 2 g Granules for oral suspension

28 sachets EU/1/04/288/003 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 07/01/2011

Protelos 2 Care 4 02/07/2010 2 g Granules for oral suspension

84 sachets EU/1/04/288/005 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 05/01/2011

Protelos Euro Registratie Collectief BV

23/06/2011 2 g Granules for oral suspension

28 sachets EU/1/04/288/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

04/07/2011

Protopic Abacus Medicine A/S

18/08/2011 0.03% Ointment 1 tube EU/1/02/201/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 12/09/2011



Denmark 12/09/2011




Denmark 12/09/2011



Denmark 12/09/2011

Protopic Autumn Healthcare Ltd

23/05/2011 0.03% Ointment 1 tube EU/1/02/201/001 Ireland, United Kingdom Ireland, United Kingdom

27/06/2011



27/06/2011



27/06/2011

Protopic Doncaster Pharmaceuticals Group Ltd

16/09/2011 0.1% Ointment 1 tube EU/1/02/201/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


23/09/2011

Protopic Doncaster Pharmaceuticals Group Ltd

19/09/2011 0.03% Ointment 1 tube EU/1/02/201/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Portugal, Spain, Sweden, The Netherlands, United Kingdom


23/09/2011

Protopic Medartuum AB 06/10/2010 0.1% Ointment 1 tube EU/1/02/201/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 11/02/2011

Protopic Medartuum AB 05/09/2011 0.1% Ointment 1 tube EU/1/02/201/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 04/10/2011

Protopic Paranova Läkemedel AB

12/10/2011 0.1% Ointment 1 tube EU/1/02/201/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 27/10/2011


Protopic Paranova Läkemedel AB

12/10/2011 0.1% Ointment 1 tube EU/1/02/201/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 27/10/2011

Puregon 2 Care 4 27/06/2011 300 IU/ 0.36 ml


1 cartridge + 2 packs with 3 pen needles

EU/1/96/008/038 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 05/07/2011

Puregon 2 Care 4 27/06/2011 600 IU/ 0.72 ml




Denmark 27/07/2011

Puregon Abacus Medicine A/S

30/09/2011 300 IU/ 0.36 ml




Sweden 18/10/2011

Puregon Axicorp Pharma GmbH

28/06/2011 900 IU/ 1.08 ml




Germany 11/07/2011


12/07/2011 300 IU/ 0.36 ml




Germany 27/07/2011


26/07/2011 600 IU/ 0.72 ml




Germany 01/08/2011

Puregon EuroPharma DK

19/05/2011 300 IU/ 0.36 ml



EU/1/96/008/038 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 31/05/2011

Puregon EuroPharma DK

19/05/2011 600 IU/ 0.72 ml



EU/1/96/008/039 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 31/05/2011


Puregon Haemato Pharm AG

08/12/2010 600 IU/ 0.72 ml



EU/1/96/008/039 Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

19/01/2011


09/12/2010 300 IU/ 0.36 ml




Austria, Germany

19/01/2011


10/12/2010 900 IU/ 1.08 ml




Austria, Germany

19/01/2011


08/03/2011 300 IU/ 0.36 ml




Denmark 17/03/2011


08/03/2011 600 IU/ 0.72 ml




Denmark 17/03/2011


08/03/2011 900 IU/ 1.08 ml




Denmark 17/03/2011


Puregon Pharmachim AB

11/03/2011 300 IU/ 0.36 ml



EU/1/96/008/038 Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 15/04/2011


11/03/2011 600 IU/ 0.72 ml




Sweden 15/04/2011


11/03/2011 900 IU/ 1.08 ml




Sweden 15/04/2011

Rapamune Kohlpharma GmbH

02/02/2011 0.5 mg Coated tablet 3 x 10 EU/1/01/171/013 Austria Germany 28/03/2011

Rapamune Kohlpharma GmbH

02/02/2011 0.5 mg Coated tablet 10 x 10 EU/1/01/171/014 Austria Germany 28/03/2011

Rapilysin Orifarm AS 28/07/2011 10 U Powder and solvent for solution for injection

2 vials + 2 pre-filled syringes + 2 reconstitution devices/needles


Denmark 05/08/2011

Rasilez Amimed Direct Ltd



15/06/2011

Rasilez Amimed Direct Ltd



15/06/2011

Rasilez Axicorp Pharma GmbH

22/02/2011 150 mg Film-coated tablet 98 EU/1/07/405/028 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/02/2011


Rasilez B&S Healthcare Ltd



17/08/2011

Rasilez B&S Healthcare Ltd



18/10/2011

Rasilez Beragena Arzneimittel GmbH

18/10/2011 150 mg Film-coated tablet 28 EU/1/07/405/022 Austria, Belgium, France, Greece, Iceland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 03/11/2011



Germany 08/11/2011



Germany 08/11/2011



Germany 08/11/2011

Rasilez CC Pharma 22/07/2011 300 mg Film-coated tablet 28 EU/1/07/405/032 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/09/2011

Rasilez cc Pharma 22/07/2011 300 mg Film-coated tablet 56 EU/1/07/405/035 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/09/2011

Rasilez CC Pharma 22/07/2011 300 mg Film-coated tablet 98 EU/1/07/405/038 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/09/2011

Rasilez Chemilines Ltd 07/01/2011 150 mg Film-coated tablet 28 EU/1/07/405/022 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands


12/04/2011

Rasilez Chemilines Ltd 07/01/2011 300 mg Film-coated tablet 28 EU/1/07/405/032 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands


12/04/2011


Rasilez Dr Fisher Farma BV


The Netherlands

05/07/2011



The Netherlands

02/08/2011



The Netherlands

02/08/2011



The Netherlands

31/08/2011

Rasilez Emra-Med 07/12/2010 300 mg Film-coated tablet 28 EU/1/07/405/032 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 20/01/2011

Rasilez Emra-Med 03/01/2011 150 mg Film-coated tablet 56 EU/1/07/405/025 Austria, Portugal Germany 24/01/2011

Rasilez Emra-Med 03/01/2011 150 mg Film-coated tablet 98 EU/1/07/405/028 Austria, Portugal Germany 24/01/2011

Rasilez Emra-Med 03/01/2011 300 mg Film-coated tablet 98 EU/1/07/405/038 Austria, Greece Germany 24/01/2011

Rasilez Eureco-Pharma B.V.


The Netherlands

25/02/2011

Rasilez Eureco-Pharma B.V.


The Netherlands

09/08/2011


Rasilez Euro Registratie Collectief BV


The Netherlands

03/08/2011

Rasilez EuroPharma DK


Denmark 11/01/2011

Rasilez EuroPharma DK

14/08/2009 150 mg Film-coated tablet 84 (3 x 28) EU/1/07/405/007 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 11/01/2011

Rasilez G-Pharma Ltd 11/01/2011 150 mg Film-coated tablet 28 EU/1/07/405/022 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


14/01/2011

Rasilez G-Pharma Ltd 11/01/2011 300 mg Film-coated tablet 28 EU/1/07/405/032 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


14/01/2011

Rasilez Kosei Pharma UK Limited



01/08/2011

Rasilez Kosei Pharma UK Limited



01/08/2011

Rasilez Lexon (UK) Ltd



15/03/2011


Rasilez Lexon (UK) Ltd



15/03/2011

Rasilez Mediwin Ltd 04/02/2011 300 mg Film-coated tablet 28 EU/1/07/405/032 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands

United Kingdom

23/03/2011

Rasilez Mediwin Ltd 11/04/2011 150 mg Film-coated tablet 28 EU/1/07/405/022 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands

United Kingdom

02/05/2011

Rasilez MPT Pharma 12/01/2011 150 mg Film-coated tablet 28 EU/1/07/405/022 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


18/01/2011



18/01/2011



25/05/2011

Rasilez PCO Manufacturing



17/02/2011

Rasilez PCO Manufacturing

17/02/2011 150 mg Film-coated tablet 28 EU/1/07/405/022 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands


08/03/2011

Rasilez Swingward Ltd TA Medihealth

16/09/2010 300 mg Film-coated tablet 28 EU/1/07/405/032 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands

United Kingdom

26/10/2011


Rasilez Swingward Ltd TA Medihealth


United Kingdom

21/11/2011

Rasilez HCT Axicorp Pharma GmbH

07/04/2011 150 mg / 12.5 mg


Germany 11/05/2011


12/05/2011 300 mg / 12.5 mg


Germany 20/05/2011


28/07/2011 300 mg / 25 mg


Germany 15/08/2011

Rasilez HCT Beragena Arzneimittel GmbH

10/10/2011 300 mg / 25 mg

Film-coated tablet 98 EU/1/08/491/078 Austria, Belgium, France, Greece, Iceland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 25/10/2011


18/10/2011 150 mg / 12.5 mg


Germany 03/11/2011


18/10/2011 300 mg / 12.5 mg


Germany 25/10/2011

Rasilez HCT Euro Registratie Collectief BV

07/07/2011 150 mg / 12.5 mg


The Netherlands

05/09/2011

Rebetol Haemato Pharm AG

09/03/2011 200 mg Capsule, hard 168 EU/1/99/107/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/04/2011

Rebetol Haemato Pharm AG


Germany 08/04/2011


Rebif CC Pharma 10/10/2011 22 µg Solution for injection

12 pre-filled pens


Germany 13/10/2011

Rebif CC Pharma 10/10/2011 44 µg Solution for injection

12 pre-filled pens


Germany 13/10/2011

Rebif CC Pharma 21/11/2011 22 µg/0.5 ml Solution for injection

12 cartridges


Germany 08/12/2011

Rebif CC Pharma 21/11/2011 44 µg/0.5 ml Solution for injection

12 cartridges


Germany 08/12/2011

Rebif Haemato Pharm AG


12 pre-filled pens

EU/1/98/063/013 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

20/07/2011

Rebif Haemato Pharm AG


12 pre-filled pens

EU/1/98/063/016 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

20/07/2011

Rebif Kohlpharma GmbH

20/12/2010 8.8 µg (2.4 m IU) + 22 µg (6 m IU)


Initiation pack: 6 pre-filled syringes of 8.8 µg + 6 pre-filled syringes of 22 µg


Rebif Orifarm OY 03/03/2011 22 µg Solution for injection


EU/1/98/063/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 09/03/2011

Rebif Pharma Westen GmbH


12 pre-filled pens


Germany 17/11/2011


Rebif Pharma Westen GmbH


12 pre-filled pens


Germany 17/11/2011

Relistor Emra-Med 26/08/2010 12 mg/0.6 ml Solution for injection

7 vials + 7 sterile syringes + 14 alcohol swabs

EU/1/08/463/003 Austria, Belgium, France, Luxembourg Germany 14/06/2011

Relistor Euro Registratie Collectief BV

23/12/2010 12 mg/0.6 ml Solution for injection

7 vials + 7 sterile syringes + 14 alcohol swabs


The Netherlands

25/01/2011

Remicade Axicorp Pharma GmbH


5 vials EU/1/99/116/005 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/06/2011

Remicade Eureco-Pharma B.V.


1 vial EU/1/99/116/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

08/02/2011

Remicade Haemato Pharm AG


1 vial EU/1/99/116/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

08/07/2011

Remicade MedicoPharm AG


5 vials EU/1/99/116/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 24/03/2011

Remicade Paranova Läkemedel AB



Sweden 29/09/2011


Remicade Paranova Läkemedel AB


3 vials EU/1/99/116/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 30/09/2011

Remicade Veron Pharma Vertriebs GmbH


2 vials EU/1/99/116/002 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 03/02/2011

Renagel Aaston Healthcare GmbH

01/03/2011 800 mg Film-coated tablet 1 bottle of 180 without outer carton


Germany 04/03/2011

Renagel Propharmed GmbH

29/03/2011 800 mg Film-coated tablet 1 bottle of 180 without outer carton


Germany 11/04/2011

Renvela Beragena Arzneimittel GmbH

05/05/2011 2.4 g Powder for oral suspension

60 sachets EU/1/09/521/006 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 25/05/2011

Renvela Beragena Arzneimittel GmbH

05/05/2011 800 mg Film-coated tablet 180 (without outer carton)


Germany 19/05/2011

Renvela CC Pharma 14/12/2010 800 mg Film-coated tablet 180 (without outer carton)

EU/1/09/521/003 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/01/2011

Renvela CC Pharma 07/01/2011 2.4 g Powder for oral suspension

60 sachets EU/1/09/521/006 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/01/2011

Renvela Cross Pharma AB



Sweden 05/04/2011

Renvela Emra-Med 18/02/2011 800 mg Film-coated tablet 180 (without outer carton)


Germany 14/03/2011


Renvela Medcor Pharmaceuticals BV

14/11/2011 2.4 g Powder for oral suspension

60 sachets EU/1/09/521/006 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

30/11/2011

Renvela Medcor Pharmaceuticals BV


EU/1/09/521/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

30/11/2011

Renvela MedicoPharm AG


EU/1/09/521/003 Austria, Belgium, Cyprus, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/02/2011

Renvela Oy Cross Pharma AB


EU/1/09/521/003 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Finland 20/04/2011

Renvela PCO Manufacturing




14/07/2011

Renvela Pharmachim AB


EU/1/09/521/003 Austria, Belgium, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 26/10/2011

Replagal Abacus Medicine A/S



Denmark 11/07/2011

Replagal NewNeopharm BV


1 vial EU/1/01/189/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 20/09/2011

Revatio Abacus Medicine A/S

06/12/2011 20 mg Film-coated tablet 90 EU/1/05/318/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/12/2011


Revatio Medartuum AB 25/08/2011 20 mg Film-coated tablet 90 EU/1/05/318/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 30/08/2011

Revatio Pharmachim AB

08/07/2011 20 mg Film-coated tablet 90 EU/1/05/318/001 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 19/07/2011

Revlimid CC Pharma 08/11/2011 10 mg Capsule, hard 21 EU/1/07/391/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011

Revlimid CC Pharma 08/11/2011 15 mg Capsule, hard 21 EU/1/07/391/003 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/11/2011

revlimid CC Pharma 08/11/2011 25 mg Capsule, hard 21 EU/1/07/391/004 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/11/2011

Revlimid Dr Fisher Farma BV

07/06/2011 25 mg Capsule, hard 21 EU/1/07/391/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

15/06/2011



The Netherlands

16/11/2011



The Netherlands

07/12/2011

Revlimid Medartuum AB 07/11/2011 25 mg Capsule, hard 21 EU/1/07/391/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 28/11/2011


Revlimid Pharma Westen GmbH

11/01/2011 25 mg Capsule, hard 21 EU/1/07/391/004 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/02/2011



Germany 09/12/2011



Germany 09/12/2011

REVOLADE CC Pharma 17/01/2011 25 mg Film-coated tablet 14 EU/1/10/612/001 Austria, Norway Germany 11/03/2011

REVOLADE CC Pharma 17/01/2011 50 mg Film-coated tablet 14 EU/1/10/612/004 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 19/01/2011

REVOLADE CC Pharma 27/01/2011 25 mg Film-coated tablet 28 EU/1/10/612/002 Austria Germany 03/03/2011

REVOLADE CC Pharma 27/01/2011 50 mg Film-coated tablet 28 EU/1/10/612/005 Austria Germany 03/03/2011

REVOLADE Haemato Pharm AG

16/02/2011 25 mg Film-coated tablet 28 EU/1/10/612/002 Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

24/03/2011

REVOLADE Haemato Pharm AG

16/02/2011 50 mg Film-coated tablet 28 EU/1/10/612/005 Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

24/03/2011

Reyataz Aaston Healthcare GmbH

21/03/2011 300 mg Capsule, hard 3 x 30 EU/1/03/267/010 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/04/2011


Reyataz Axicorp Pharma B.V.

09/02/2011 300 mg Capsule, hard 3 x 30 EU/1/03/267/010 Austria, Belgium, Bulgaria, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/02/2011

Reyataz BB Farma s.r.l.


Germany 12/12/2011

Reyataz BB Farma s.r.l.


Germany 12/12/2011

Reyataz Dr Fisher Farma BV


The Netherlands

26/04/2011

Reyataz EU-Pharma BV 29/11/2011 300 mg Capsule, hard 30 EU/1/03/267/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

06/12/2011

Reyataz Medartuum AB 08/08/2011 300 mg Capsule, hard 30 EU/1/03/267/008 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/08/2011

Reyataz MedicoPharm AG

25/02/2009 300 mg Capsule, hard 30 EU/1/03/267/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/07/2011

Reyataz Pharmachim AB

04/08/2011 300 mg Capsule, hard 30 EU/1/03/267/008 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 08/08/2011


Rilutek MedicoPharm AG


Germany 21/02/2011

Rilutek Paranova Läkemedel AB


Sweden 29/03/2011

RoActemra CC Pharma 20/01/2011 20 mg/ml Concentrate for solution for infusion

4 vials EU/1/08/492/006 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/01/2011

RoActemra CC Pharma 20/01/2011 20 mg/ml Concentrate for solution for infusion

4 vials EU/1/08/492/004 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Latvia, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/01/2011

RoActemra Emra-Med 27/10/2011 20 mg/ml Concentrate for solution for infusion


Germany 23/11/2011


4 vials EU/1/08/492/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 23/11/2011



Germany 23/11/2011



Germany 23/11/2011

RoActemra Pharma Westen GmbH



Germany 20/10/2011

RoActemra Pharma Westen GmbH



Germany 25/10/2011


Sifrol Axicorp Pharma GmbH



Germany 28/10/2011




Germany 28/10/2011




Germany 28/10/2011

Sifrol BR Pharma International Ltd



Germany 17/01/2011




Germany 02/03/2011




Germany 21/06/2011

Sifrol MTK Pharma GmbH


30 EU/1/97/050/029 Norway, The Netherlands Germany 25/01/2011

Sifrol MTK Pharma GmbH


100 EU/1/97/050/030 Norway, The Netherlands Germany 18/02/2011

Sifrol Pharma Westen GmbH



Germany 08/03/2011




Germany 08/03/2011




Germany 29/03/2011





Germany 14/04/2011

Simponi Haemato Pharm AG


3 (3 x 1) pre-filled pens


Germany 07/09/2011

Simponi Orifarm AB 05/10/2011 50 mg Solution for injection in pre-filled pen

1 pre-filled pen


Sweden 04/11/2011

Simponi Orifarm AS 05/05/2011 50 mg Solution for injection in pre-filled pen

1 pre-filled pen


Denmark 11/05/2011

Somavert CC Pharma 16/12/2010 15 mg Powder and solvent for solution for injection

30 vials + 30 vials


Germany 04/02/2011

Somavert Orifarm AS 22/07/2011 10 mg Powder and solvent for solution for injection

30 vials + 30 vials


Denmark 02/08/2011


30 vials + 30 vials


Denmark 02/08/2011


30 vials + 30 vials


Denmark 02/08/2011


SonoVue Orifarm AB 27/07/2011 8 µl/ml Powder and solvent for dispersion for injection

1 vial + 1 pre-filled syringe + 1 'MiniSpike' rec. device


Sweden 17/08/2011

Sprycel CC Pharma 24/05/2011 50 mg Film-coated tablet 60 x 1 (unit dose)


Germany 01/06/2011



Germany 30/05/2011



Germany 16/08/2011

Sprycel Haemato Pharm AG


Denmark 30/06/2011

Sprycel Omnia Läkemedel AB

09/06/2011 50 mg Film-coated tablet 60 EU/1/06/363/002 Bulgaria, Germany, Greece, The Netherlands, United Kingdom

Sweden 14/06/2011

Sprycel Omnia Läkemedel AB

11/11/2011 100 mg Film-coated tablet 30 EU/1/06/363/010 Portugal, Spain, The Netherlands, United Kingdom

Sweden 16/11/2011

Stalevo BR Pharma International Ltd

10/11/2011 150 mg / 37.5 mg / 200 mg


Germany 07/12/2011

Stalevo Euro Registratie Collectief BV

19/07/2011 50 mg / 12.5 mg / 200 mg


The Netherlands

26/07/2011


25/07/2011 100 mg / 25 mg / 200 mg


The Netherlands

26/07/2011


13/09/2011 125 mg / 31.25 mg / 200 mg


The Netherlands

15/09/2011



13/09/2011 150 mg / 37.5 mg / 200 mg


The Netherlands

15/09/2011


20/09/2011 200 mg / 50 mg / 200 mg


The Netherlands

22/09/2011

Stalevo EuroPharma DK

14/02/2011 125 mg / 31.25 mg / 200 mg

Film-coated tablet 100 EU/1/03/260/031 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 01/03/2011

Stalevo EuroPharma DK

14/02/2011 75 mg / 18.75 mg / 200 mg

Film-coated tablet 100 EU/1/03/260/026 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 01/03/2011

Stalevo Haemato Pharm AG

26/04/2011 100 mg / 25 mg / 200 mg

Film-coated tablet 100 EU/1/03/260/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/05/2011


26/04/2011 150 mg / 37.5 mg / 200 mg


Denmark 19/05/2011


26/04/2011 50 mg / 12.5 mg / 200 mg


Denmark 19/05/2011


26/04/2011 50 mg / 12.5 mg / 200 mg


Denmark 19/05/2011


27/04/2011 100 mg / 25 mg / 200 mg


Denmark 19/05/2011



27/04/2011 150 mg / 37.5 mg / 200 mg

Film-coated tablet 100 EU/1/03/260/011 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/05/2011

Stalevo Imed Healthcare Ltd

14/07/2011 100 mg / 25 mg / 200 mg

Film-coated tablet 100 EU/1/03/260/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


20/07/2011

Stalevo Kohlpharma GmbH

22/09/2011 125 mg / 31.25 mg / 200 mg

Film-coated tablet 30 EU/1/03/260/030 France, Italy, The Netherlands, United Kingdom

Germany 27/10/2011

Stalevo Lexon (UK) Ltd

12/12/2011 100 mg / 25 mg / 200 mg



20/12/2011


12/12/2011 150 mg / 37.5 mg / 200 mg



20/12/2011


12/12/2011 50 mg / 12.5 mg / 200 mg



20/12/2011

Stalevo Orifarm AS 23/09/2011 125 mg / 31.25 mg / 200 mg


Denmark 17/10/2011

Stelara Orifarm AB 21/07/2011 45 mg Solution for injection in pre-filled syringe



Sweden 09/08/2011


Stocrin 2 Care 4 11/01/2011 600 mg Film-coated tablet 30 EU/1/99/111/008 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 14/01/2011

Stocrin Medcor Pharmaceuticals BV


The Netherlands

23/03/2011

Stocrin Medcor Pharmaceuticals BV


The Netherlands

03/05/2011

Stocrin Propharmed GmbH


Germany 20/04/2011

Suboxone EuroPharma DK

08/07/2011 2 mg/0.5 mg Sublingual tablet 7 EU/1/06/359/001 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 12/07/2011

Suboxone EuroPharma DK

08/07/2011 2 mg/0.5 mg Sublingual tablet 28 EU/1/06/359/002 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 12/07/2011

Suboxone Omnia Läkemedel AB

18/10/2011 8 mg/2 mg Sublingual tablet 7 EU/1/06/359/003 The Netherlands, United Kingdom Sweden 14/11/2011

Suboxone Omnia Läkemedel AB

18/10/2011 8 mg/2 mg Sublingual tablet 28 EU/1/06/359/004 The Netherlands, United Kingdom Sweden 14/11/2011

Sustiva Orifarm AS 23/03/2011 600 mg Film-coated tablet 30 EU/1/99/110/009 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 05/04/2011

Sustiva Propharmed GmbH


Germany 11/08/2011

Sutent Omnia Läkemedel AB

23/08/2011 50 mg Capsule, hard 30 EU/1/06/347/003 Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/09/2011



14/11/2011 25 mg Capsule, hard 28 EU/1/06/347/005 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 08/12/2011


14/11/2011 50 mg Capsule, hard 28 EU/1/06/347/006 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 08/12/2011

Sutent Orifarm AB 21/03/2011 25 mg Capsule, hard 28 EU/1/06/347/005 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 11/05/2011

Sutent Orifarm AB 21/03/2011 50 mg Capsule, hard 28 EU/1/06/347/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 11/05/2011

Sutent Orifarm AB 04/11/2011 12.5 mg Capsule, hard 28 EU/1/06/347/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 15/11/2011

Sutent UAB East Europe Pharmacy Group

12/04/2011 50 mg Capsule, hard 30 EU/1/06/347/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


Sutent UAB East Europe Pharmacy Group

05/07/2011 50 mg Capsule, hard 28 EU/1/06/347/006 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom



Synagis Lex ano UAB 08/03/2011 100 mg Powder and solvent for solution for injection

1 vial + 1 ampoule

EU/1/99/117/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


Synagis Orifarm OY 14/03/2011 100 mg Powder and solvent for solution for injection

1 vial + 1 ampoule


Finland 14/04/2011

TachoSil Orifarm AB 14/02/2011 - - Medicated sponge 1 sponge of 9.5 x 4.8 cm


Sweden 08/03/2011

TachoSil Orifarm AB 14/02/2011 - - Medicated sponge 2 sponges of 4.8 x 4.8 cm


Sweden 24/03/2011

TachoSil Orifarm AB 14/02/2011 - - Medicated sponge 1 sponge of 3.0 x 2.5 cm


Sweden 08/03/2011

TachoSil Orifarm AB 14/02/2011 - - Medicated sponge 5 sponges of 3.0 x 2.5 cm


Sweden 08/03/2011

Tarceva CC Pharma 24/05/2011 25 mg Film-coated tablet 30 EU/1/05/311/001 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/06/2011


Tarceva Medcor Pharmaceuticals BV

03/11/2011 150 mg Film-coated tablet 30 EU/1/05/311/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany,Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

The Netherlands

10/11/2011

Tarceva Orifarm AB 09/03/2011 100 mg Film-coated tablet 30 EU/1/05/311/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 18/03/2011

Tarceva Paranova Läkemedel AB


Sweden 05/10/2011

Tarceva Paranova Läkemedel AB


Sweden 05/10/2011

Targretin Axicorp Pharma GmbH

15/11/2011 75 mg Capsule, soft 100 EU/1/01/178/001 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 21/11/2011

Targretin MedicoPharm AG

10/02/2011 75 mg Capsule, soft 100 EU/1/01/178/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/03/2011

Targretin Propharmed GmbH

21/02/2011 75 mg Capsule, soft 100 EU/1/01/178/001 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/04/2011

Tasigna CC Pharma 24/05/2011 150 mg Capsule, hard 112 EU/1/07/422/006 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/05/2011


Tasigna Emra-Med 07/09/2011 150 mg Capsule, hard 112 (4x28); (multipack)


Germany 04/10/2011

Tasigna Haemato Pharm AG


Germany 31/08/2011

Tasigna Omnia Läkemedel AB

21/11/2011 200 mg Capsule, hard 112 (4x28); (multipack)

EU/1/07/422/003 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 08/12/2011

Tasigna Orifarm AS 18/11/2011 200 mg Capsule, hard 112 (4x28); (multipack)


Sweden 29/11/2011

Tasmar Emra-Med 09/09/2011 100 mg Film-coated tablet 30 EU/1/97/044/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 20/09/2011

Taxotere Axicorp Pharma GmbH


1 vial EU/1/95/002/004 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/07/2011

Taxotere Pharma Westen GmbH



Germany 26/07/2011

Telzir Paranova OY 09/03/2011 700 mg Film-coated tablet 60 EU/1/04/282/001 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 04/04/2011

Telzir Propharmed GmbH


Germany 02/03/2011


Temodal BB Farma s.r.l.


Germany 19/07/2011

Temodal BB Farma s.r.l.


Germany 19/07/2011

Temodal BR Pharma International Ltd

26/03/2009 100 mg Capsule, hard 5 EU/1/98/096/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 10/02/2011

Temodal Medartuum AB 17/05/2011 100 mg Capsule, hard 20 EU/1/98/096/016 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 30/05/2011

Temodal Orifarm AB 21/06/2011 140 mg Capsule, hard 5 EU/1/98/096/017 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/08/2011

Temodal Orifarm AB 21/06/2011 180 mg Capsule, hard 5 EU/1/98/096/019 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/08/2011

Thyrogen Orifarm OY 11/03/2011 0.9 mg Powder for solution for injection

2 vials EU/1/99/122/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 11/05/2011

Toviaz 2 Care 4 10/12/2010 4 mg Prolonged-release tablet

84 EU/1/07/386/011 Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 07/03/2011




Sweden 04/03/2011



Sweden 04/03/2011



Sweden 07/03/2011


98 EU/1/07/386/005 Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 01/12/2011


98 EU/1/07/386/010 Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 01/12/2011

Toviaz Amimed Direct Ltd


28 EU/1/07/386/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom


01/07/2011

Toviaz Cross Pharma AB



Sweden 02/02/2011




Sweden 02/02/2011





Sweden 02/02/2011

Toviaz Doncaster Pharmaceuticals Group Ltd


28 EU/1/07/386/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


11/04/2011

Toviaz Doncaster Pharmaceuticals Group Ltd


28 EU/1/07/386/008 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


11/04/2011

Toviaz Emra-Med 09/09/2011 4 mg Prolonged-release tablet

100 (10 x 10)


Germany 24/10/2011

Toviaz Medartuum AB 21/02/2011 8 mg Prolonged-release tablet

84 EU/1/07/386/012 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 02/03/2011

Toviaz Medartuum AB 08/11/2011 4 mg Prolonged-release tablet


Sweden 16/11/2011

Toviaz Omnia Läkemedel AB


84 EU/1/07/386/011 Czech Republic, France, Greece, Italy, Spain, United Kingdom

Sweden 17/06/2011


Toviaz Omnia Läkemedel AB


84 EU/1/07/386/012 Czech Republic, France, Greece, Italy, Poland, Spain, United Kingdom

Sweden 14/06/2011

Toviaz Paranova Danmark AS


28 EU/1/07/386/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 07/06/2011




Denmark 08/06/2011




Denmark 07/06/2011




Denmark 08/06/2011

Toviaz Paranova Läkemedel AB



Sweden 27/10/2011




Sweden 27/10/2011





Sweden 27/10/2011




Sweden 27/10/2011

Toviaz PCO Manufacturing


28 EU/1/07/386/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


02/08/2011

Toviaz PCO Manufacturing


28 EU/1/07/386/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


02/08/2011

Toviaz Pharma Westen GmbH


100 (10 x 10)

EU/1/07/386/017 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/03/2011

Toviaz Pharmachim AB


28 EU/1/07/386/003 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 13/10/2011

Toviaz Pharmachim AB


84 EU/1/07/386/011 Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 12/10/2011

Toviaz Profind Wholesale Ltd.


28 EU/1/07/386/003 United Kingdom Ireland 05/09/2011

Toviaz Profind Wholesale Ltd.


28 EU/1/07/386/008 United Kingdom Ireland 05/09/2011


Toviaz Waymade PLC 07/04/2011 4 mg Prolonged-release tablet

28 EU/1/07/386/003 Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom


17/05/2011

Tracleer Haemato Pharm AG

09/03/2011 125 mg Film-coated tablet 56 EU/1/02/220/004 Austria, Belgium, Cyprus, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/04/2011


09/03/2011 125 mg Film-coated tablet 56 EU/1/02/220/004 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

30/03/2011


09/03/2011 62.5 mg Film-coated tablet 56 EU/1/02/220/002 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 26/04/2011


09/03/2011 62.5 mg Film-coated tablet 56 EU/1/02/220/002 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Austria, Germany

30/03/2011

Tracleer NewNeopharm BV

06/09/2011 125 mg Film-coated tablet 56 EU/1/02/220/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 15/09/2011

Tracleer NewNeopharm BV

06/09/2011 62.5 mg Film-coated tablet 56 EU/1/02/220/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 15/09/2011

Tracleer Orifarm AB 12/10/2011 125 mg Film-coated tablet 56 EU/1/02/220/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 17/10/2011


Tracleer Orifarm AB 12/10/2011 62.5 mg Film-coated tablet 56 EU/1/02/220/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 20/10/2011

Tractocile NewNeopharm BV


1 vial EU/1/99/124/002 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 20/09/2011

Tredaptive Emra-Med 07/01/2011 1000 mg / 20 mg

Modified-release tablet


Germany 11/01/2011

Trizivir Aaston Healthcare GmbH

29/04/2011 - - Film-coated tablet 60 EU/1/00/156/004 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/05/2011

Trizivir Docpharm GmbH&CoKGaA

26/01/2011 - - Film-coated tablet 60 EU/1/00/156/002 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 02/02/2011

Trizivir Docpharm GmbH&CoKGaA

05/09/2011 - - Film-coated tablet 60 EU/1/00/156/004 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 20/09/2011

Trizivir Emra-Med 07/12/2010 - - Film-coated tablet 60 EU/1/00/156/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/03/2011

Trizivir Haemato Pharm AG

27/10/2011 - - Film-coated tablet 60 EU/1/00/156/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/11/2011

Trizivir Kohlpharma GmbH

20/12/2010 - - Film-coated tablet 60 EU/1/00/156/004 Austria, Belgium, France, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/02/2011

Trizivir Medcor Pharmaceuticals BV

30/05/2011 - - Film-coated tablet 60 EU/1/00/156/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden, United Kingdom

The Netherlands

27/06/2011


Trizivir Mevita HandelsGmbH

10/12/2010 - - Film-coated tablet 60 EU/1/00/156/004 Austria, France, Italy, The Netherlands, United Kingdom

Germany 28/10/2011

Trizivir Propharmed GmbH

07/04/2011 - - Film-coated tablet 60 EU/1/00/156/002 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/04/2011

Trobalt BR Pharma International Ltd

16/08/2011 100 mg Film-coated tablet 84 EU/1/11/681/005 Ireland, United Kingdom Germany 22/08/2011






18/08/2011 200 mg Film-coated tablet 168 (2 x 84) (multipack)

EU/1/11/681/008 Ireland, United Kingdom Germany 22/08/2011


18/08/2011 300 mg Film-coated tablet 168 (2 x 84) (multipack)

EU/1/11/681/010 Ireland, United Kingdom Germany 22/08/2011

Trobalt Orifarm AS 04/10/2011 100 mg Film-coated tablet 84 EU/1/11/681/005 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 24/11/2011


Denmark 06/12/2011


Denmark 24/11/2011

Truvada eurorx Arzneimittel GmbH

17/11/2010 200 mg/ 245 mg

Film-coated tablet 30 EU/1/04/305/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 05/01/2011

Truvada Haemato Pharm AG

01/06/2011 200 mg/ 245 mg


Denmark 16/06/2011


Truvada Lex ano UAB 09/03/2011 200 mg/ 245 mg

Film-coated tablet 30 EU/1/04/305/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


Truvada MedicoPharm AG

28/01/2011 200 mg/ 245 mg

Film-coated tablet 3 x 30 EU/1/04/305/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/02/2011

Truvada Orifarm OY 16/02/2011 200 mg/ 245 mg


Finland 23/03/2011

Truvada Paranova OY 09/03/2011 200 mg/ 245 mg

Film-coated tablet 30 EU/1/04/305/001 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 04/04/2011

Truvada Pharmachim AB

18/11/2011 200 mg/ 245 mg

Film-coated tablet 30 EU/1/04/305/001 Austria, Belgium, France, Germany, Greece, Ireland, Italy, Malta, Norway, Spain, The Netherlands, United Kingdom

Sweden 07/12/2011

Twinrix Adult BB Farma s.r.l.


1 syringe with separate needle


Germany 30/11/2011

Twinrix Adult BB Farma s.r.l.


10 syringes with separate needle


Germany 30/11/2011


TWYNSTA Emra-Med 20/06/2011 40 mg/5 mg Tablet 28 EU/1/10/648/002 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 30/06/2011


Germany 30/06/2011


Germany 29/06/2011


Germany 30/06/2011

TWYNSTA Emra-Med 15/09/2011 80 mg/5 mg Tablet 56 EU/1/10/648/018 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/10/2011

Twynsta Kohlpharma GmbH

23/11/2011 80 mg/10 mg Tablet 98 EU/1/10/648/027 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/12/2011

Twynsta Kohlpharma GmbH

23/11/2011 80 mg/5 mg Tablet 98 EU/1/10/648/020 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 01/12/2011

Tygacil Abacus Medicine A/S

15/07/2011 50 mg Powder for solution for infusion

10 vials EU/1/06/336/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 01/08/2011


Tygacil Orifarm AB 10/05/2011 50 mg Powder for solution for infusion


Sweden 13/05/2011

Tysabri Axicorp Pharma B.V.



Germany 21/06/2011

Tysabri Haemato Pharm AG



Denmark 22/12/2011

Tysabri Orifarm AB 18/03/2011 300 mg Concentrate for solution for infusion


Sweden 31/03/2011

Tysabri Orifarm OY 11/03/2011 300 mg Concentrate for solution for infusion


Finland 24/03/2011

Tyverb Abacus Medicine A/S

05/07/2011 250 mg Film-coated tablet 70 EU/1/07/440/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 11/07/2011

Tyverb Abacus Medicine A/S

07/07/2011 250 mg Film-coated tablet 70 EU/1/07/440/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 10/08/2011

Tyverb CC Pharma 30/08/2011 250 mg Film-coated tablet 70 EU/1/07/440/004 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 23/09/2011


Tyverb Emra-Med 07/10/2011 250 mg Film-coated tablet 70 EU/1/07/440/004 Ireland, The Netherlands, United Kingdom Germany 20/10/2011

Tyverb Haemato Pharm AG


Denmark 05/05/2011

Tyverb Orifarm AB 13/05/2011 250 mg Film-coated tablet 70 EU/1/07/440/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 23/05/2011

Tyverb Orifarm AB 21/09/2011 250 mg Film-coated tablet 70 (Bottle) EU/1/07/440/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/09/2011

Tyverb Orifarm AS 27/07/2011 250 mg Film-coated tablet 70 EU/1/07/440/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 05/08/2011

Tyverb Pharma Westen GmbH


Germany 08/11/2011

Urorec Beragena Arzneimittel GmbH

01/09/2011 4 mg Capsule, hard 100 EU/1/09/608/007 Austria, Belgium, France, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 16/09/2011



Germany 16/09/2011



Germany 16/09/2011



Germany 16/09/2011

Urorec BERAGENA Arzneimittel GmbH


Germany 13/12/2011


Urorec BERAGENA Arzneimittel GmbH


Germany 13/12/2011

Urorec CC Pharma 12/09/2011 8 mg Capsule, hard 50 EU/1/09/608/012 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/09/2011

Urorec CC Pharma 12/09/2011 8 mg Capsule, hard 100 EU/1/09/608/014 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/09/2011

Urorec Emra-Med 11/07/2011 8 mg Capsule, hard 100 EU/1/09/608/014 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/07/2011


Germany 18/07/2011


Germany 26/09/2011

Urorec Kohlpharma GmbH

12/09/2011 8 mg Capsule, hard 20 EU/1/09/608/010 France, Italy Germany 19/09/2011






06/10/2011 4 mg Capsule, hard 100 EU/1/09/608/007 Italy Germany 13/10/2011


10/11/2011 4 mg Capsule, hard 30 EU/1/09/608/004 Italy, Portugal Germany 15/11/2011

Urorec Pharma Westen Ges.m.b.H.


Germany 12/12/2011


Valdoxan Amimed Direct Ltd



12/07/2011

Valdoxan axicorp Pharma GmbH


Germany 07/12/2011

Valdoxan Emra-Med 05/05/2011 25 mg Film-coated tablet 28 EU/1/08/499/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/05/2011

Valdoxan Emra-Med 05/05/2011 25 mg Film-coated tablet 98 EU/1/08/499/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/05/2011

Valdoxan Medcor Pharmaceuticals BV


The Netherlands

02/05/2011

Valdoxan STRATHCLYDE PHARMACEUTICALS LTD



08/12/2011

Vectibix Orifarm AB 19/05/2011 20 mg/ml Concentrate for solution for infusion


Sweden 25/05/2011

Vectibix Orifarm AB 19/05/2011 20 mg/ml Concentrate for solution for infusion


Sweden 25/05/2011


Vectibix Orifarm AS 11/05/2011 20 mg/ml Concentrate for solution for infusion


Denmark 24/06/2011

Vectibix Orifarm AS 11/05/2011 20 mg/ml Concentrate for solution for infusion


Denmark 24/06/2011

VELCADE Abacus Medicine A/S

07/07/2011 3.5 mg Powder for solution for injection

1 vial EU/1/04/274/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/07/2011

VELCADE Inopha GmbH 26/05/2011 3.5 mg Powder for solution for injection


Sweden 16/06/2011

VELCADE Orifarm OY 24/02/2011 3.5 mg Powder for solution for injection


Finland 25/05/2011

VELCADE Propharmed GmbH

24/03/2011 3.5 mg Powder for solution for injection

1 vial EU/1/04/274/001 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/04/2011

Ventavis CC Pharma 26/04/2011 10 µg/ml Nebuliser solution 30 ampoules


Germany 06/05/2011

Ventavis CC Pharma 26/04/2011 10 µg/ml Nebuliser solution 168 ampoules


Germany 06/05/2011


Vfend 2 Care 4 06/12/2010 200 mg Tablet 56 EU/1/02/212/020 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Romania, Spain, The Netherlands, United Kingdom

Sweden 08/03/2011


Sweden 08/03/2011


Sweden 08/03/2011


Denmark 03/03/2011

Vfend Abacus Medicine A/S


1 vial EU/1/02/212/025 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 13/07/2011

Vfend Beragena Arzneimittel GmbH


Germany 22/12/2011

Vfend BR Pharma International Ltd



16/02/2011

Vfend EuroPharma DK

11/02/2011 40 mg/ml Powder for oral suspension

1 bottle EU/1/02/212/026 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 02/03/2011

Vfend Haemato Pharm AG


1 vial EU/1/02/212/025 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 13/07/2011

Vfend Medartuum AB 05/07/2011 200 mg Tablet 28 EU/1/02/212/017 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 12/08/2011


Vfend Medartuum AB 05/07/2011 200 mg Tablet 56 EU/1/02/212/020 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, The Netherlands, United Kingdom

Sweden 22/07/2011

Vfend MedicoPharm AG

24/11/2009 200 mg Tablet 30 EU/1/02/212/018 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/02/2011

Vfend Orifarm AS 30/09/2010 200 mg Tablet 28 EU/1/02/212/017 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 10/01/2011

Vfend Orifarm AS 06/12/2011 200 mg Tablet 56 EU/1/02/212/020 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/12/2011

Vfend Paranova Läkemedel AB

27/09/2011 200 mg Tablet 28 EU/1/02/212/017 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 04/10/2011

Vfend PCO Manufacturing

11/07/2011 200 mg Tablet 28 EU/1/02/212/017 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


08/08/2011

Vfend Pharma Westen GmbH

14/03/2011 200 mg Tablet 100 EU/1/02/212/021 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/03/2011

Viagra BCN Farma SL 24/01/2011 100 mg Film-coated tablet 4 EU/1/98/077/010 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, The Netherlands, United Kingdom

Spain 01/02/2011



Spain 01/02/2011


Spain 01/02/2011


Spain 01/02/2011

Viagra CC Pharma 16/11/2011 25 mg Film-coated tablet 4 EU/1/98/077/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/12/2011

Viagra Emra-Med 11/03/2011 50 mg Film-coated tablet 4 EU/1/98/077/006 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/03/2011

Viagra Medartuum AB 31/03/2010 50 mg Film-coated tablet 12 EU/1/98/077/008 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 30/05/2011

Viagra Omnia Läkemedel AB

13/05/2011 50 mg Film-coated tablet 12 EU/1/98/077/008 France, Germany, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Sweden 02/08/2011

Viagra Orifarm AS 29/11/2011 100 mg Film-coated tablet 8 EU/1/98/077/011 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/12/2011


Viagra PCO Manufacturing

19/01/2009 100 mg Film-coated tablet 4 EU/1/98/077/010 Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Iceland, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom


07/02/2011

Victoza Abacus Medicine A/S

08/04/2011 6 mg/ml Solution for injection in pre-filled pen

3 pre-filled pens


Denmark 19/04/2011



1 pre-filled pen


Denmark 07/06/2011



2 pre-filled pens


Denmark 07/06/2011

Victoza CC Pharma 31/01/2011 6 mg/ml Solution for injection in pre-filled pen

5 pre-filled pens


Germany 04/02/2011

Victoza Cross Pharma AB


3 pre-filled pens


Sweden 30/05/2011

Victoza Dr Fisher Farma BV


2 pre-filled pens


The Netherlands

10/05/2011

Victoza Medartuum AB 05/12/2011 6 mg/ml Solution for injection in pre-filled pen

3 pre-filled pens


Sweden 08/12/2011


Victoza Medcor Pharmaceuticals BV


2 pre-filled pens


The Netherlands

15/06/2011

Victoza Orifarm AS 07/09/2011 6 mg/ml Solution for injection in pre-filled pen

3 pre-filled pens


Denmark 15/09/2011

Victoza Paranova Danmark AS


2 pre-filled pens


Denmark 30/06/2011

Victoza Paranova Danmark AS


3 pre-filled pens


Denmark 30/06/2011

Victoza Paranova Läkemedel AB


3 pre-filled pens


Sweden 07/02/2011

Victoza Paranova OY 25/05/2011 6 mg/ml Solution for injection in pre-filled pen

3 pre-filled pens

EU/1/09/529/003 Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Finland 04/07/2011

Victoza PCO Manufacturing


2 pre-filled pens



07/06/2011

Victoza Pharmachim AB


3 pre-filled pens

EU/1/09/529/003 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 11/11/2011


Victoza Pharmachim AB


2 pre-filled pens

EU/1/09/529/002 Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands

Sweden 14/11/2011

Victrelis HAEMATO PHARM AG

15/12/2011 200 mg Capsule, hard 336 (4 packs of 84) hard


Germany 22/12/2011

Vidaza Abacus Medicine A/S

07/07/2011 25 mg/ml Powder for suspension for injection

1 vial EU/1/08/488/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 22/07/2011

Vidaza Orifarm AB 10/12/2010 25 mg/ml Powder for suspension for injection


Sweden 03/01/2011

Vimpat Axicorp Pharma GmbH


Germany 25/02/2011



Germany 29/03/2011



Germany 30/09/2011

Vimpat B2B Medical GmbH

10/06/2011 100 mg Film-coated tablet 56 EU/1/08/470/005 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 13/07/2011



Germany 13/07/2011




Germany 13/07/2011



Germany 10/10/2011

Vimpat Beragena Arzneimittel GmbH


Germany 19/12/2011

Vimpat BR Pharma International Ltd


Germany 07/06/2011

Vimpat BR Pharma International Ltd


Germany 08/06/2011

Vimpat Doncaster Pharmaceuticals Group Ltd



02/02/2011




21/02/2011




21/02/2011

Vimpat Dr Fisher Farma BV


The Netherlands

19/04/2011

Vimpat Dr Fisher Farma BV


The Netherlands

28/11/2011


Vimpat Emra-Med 14/10/2011 50 mg Film-coated tablet 168 EU/1/08/470/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 21/12/2011


Germany 21/12/2011


Germany 21/12/2011


Germany 21/12/2011


Germany 21/12/2011

Vimpat G-Pharma Ltd 14/02/2011 100 mg Film-coated tablet 14 EU/1/08/470/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


02/03/2011



02/03/2011



02/03/2011



02/03/2011




02/03/2011



02/03/2011

Vimpat Kohlpharma GmbH

10/11/2011 50 mg Film-coated tablet 168 EU/1/08/470/003 Belgium, France, Greece, Italy, The Netherlands

Germany 15/11/2011

Vimpat Mevita HandelsGmbH


Germany 15/08/2011



Germany 15/08/2011



Germany 15/08/2011

Vimpat O.P.D. Laboratories Ltd

24/06/2011 100 mg Film-coated tablet 14 EU/1/08/470/004 Belgium, Denmark, France, Germany, Greece, Italy, Portugal, Spain, Sweden, The Netherlands

United Kingdom

18/08/2011



United Kingdom

18/08/2011


24/06/2011 50 mg Film-coated tablet 14 EU/1/08/470/001 Belgium, Denmark, France, Germany, Greece, Italy, Portugal, Spain, Sweden

United Kingdom

18/08/2011

Vimpat Swingward Ltd TA Medihealth


United Kingdom

03/05/2011

Vimpat Veron Pharma Vertriebs GmbH

23/11/2011 100 mg Film-coated tablet 56 EU/1/08/470/005 Austria, Greece Germany 22/12/2011


23/11/2011 100 mg Film-coated tablet 168 EU/1/08/470/006 Austria Germany 22/12/2011





23/11/2011 200 mg Film-coated tablet 56 EU/1/08/470/011 Austria, Greece Germany 22/12/2011


23/11/2011 50 mg Film-coated tablet 56 EU/1/08/470/002 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 22/12/2011



Vimpat Vital Supplies UK Limited


United Kingdom

22/08/2011



United Kingdom

22/08/2011



United Kingdom

28/11/2011

Vimpat Waymade PLC 13/07/2011 100 mg Film-coated tablet 56 EU/1/08/470/005 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom


15/07/2011



15/07/2011



16/09/2011

Viramune Axicorp Pharma GmbH

17/02/2011 200 mg Tablet 120 EU/1/97/055/003 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/03/2011

Viramune EU-Pharma BV 10/11/2011 200 mg Tablet 60 EU/1/97/055/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

29/11/2011


Viramune Orifarm OY 24/02/2011 200 mg Tablet 60 EU/1/97/055/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 16/03/2011

Viramune Paranova OY 16/03/2011 200 mg Tablet 60 EU/1/97/055/001 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 01/04/2011

Viread EuroPharma DK


Denmark 14/07/2011

Visudyne Orifarm AB 21/07/2011 15 mg Powder for solution for infusion


Sweden 26/07/2011

Volibris Haemato Pharm AG


Austria, Germany

16/03/2011

Volibris Haemato Pharm AG


Austria, Germany

16/03/2011

Votrient Emra-Med 30/08/2011 200 mg Film-coated tablet 30 EU/1/10/628/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/09/2011


Votrient Emra-Med 30/08/2011 400 mg Film-coated tablet 30 EU/1/10/628/003 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 14/09/2011

Votrient Orifarm AB 18/11/2011 400 mg Film-coated tablet 60 EU/1/10/628/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 29/11/2011

Votrient Pharma Westen GmbH


Germany 06/09/2011

Votrient Pharma Westen GmbH

07/09/2011 400 mg Film-coated tablet 60 EU/1/10/628/004 Austria, Belgium, Bulgaria, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/10/2011

VPRIV CC Pharma GmbH

06/12/2011 400 U Powder for solution for infusion

1 vial EU/1/10/646/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 08/12/2011

Xagrid 2 Care 4 08/02/2011 0.5 mg Capsule, hard 100 EU/1/04/295/001 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 23/03/2011

Xarelto Abacus Medicine A/S

29/06/2011 10 mg Film-coated tablet 30 EU/1/08/472/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 25/07/2011

Xarelto Abacus Medicine A/S

08/07/2011 10 mg Film-coated tablet 100 x 1 EU/1/08/472/008 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 25/07/2011


Xarelto Clear Pharmacy



21/11/2011

Xarelto Clear Pharmacy



22/11/2011

Xarelto Doncaster Pharmaceuticals Group Ltd



12/10/2011

Xarelto Doncaster Pharmaceuticals Group Ltd



12/10/2011

Xarelto Dr Fisher Farma BV


The Netherlands

30/08/2011

Xarelto Emra-Med 01/02/2011 10 mg Film-coated tablet 10 EU/1/08/472/006 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 02/02/2011

Xarelto Emra-Med 01/02/2011 10 mg Film-coated tablet 30 EU/1/08/472/007 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 03/02/2011

Xarelto EU-Pharma BV 12/07/2011 10 mg Film-coated tablet 30 EU/1/08/472/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

12/07/2011

Xarelto EU-Pharma BV 27/09/2011 10 mg Film-coated tablet 30 EU/1/08/472/007 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

05/10/2011


Xarelto Eureco-Pharma B.V.


The Netherlands

21/02/2011

Xarelto Eureco-Pharma B.V.


The Netherlands

03/11/2011

Xarelto EuroPharma DK

14/04/2011 10 mg Film-coated tablet 10 EU/1/08/472/006 Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 18/04/2011


14/04/2011 10 mg Film-coated tablet 100 x 1 EU/1/08/472/008 Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 18/04/2011


14/04/2011 10 mg Film-coated tablet 30 EU/1/08/472/007 Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 18/04/2011

Xarelto Medcor Pharmaceuticals BV

24/02/2011 10 mg Film-coated tablet 30 EU/1/08/472/007 Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

15/03/2011

Xarelto Medcor Pharmaceuticals BV

26/04/2011 10 mg Film-coated tablet 10 EU/1/08/472/006 Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

03/05/2011

Xeloda Axicorp Pharma GmbH

09/06/2011 500 mg Film-coated tablet 120 EU/1/00/163/002 Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom

Germany 27/06/2011


Xeloda Dr Fisher Farma BV

09/12/2010 150 mg Film-coated tablet 60 EU/1/00/163/001 Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, United Kingdom

The Netherlands

04/01/2011

Xeloda Inopha GmbH 22/03/2011 500 mg Film-coated tablet 120 EU/1/00/163/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

The Netherlands

23/03/2011

Xeloda Orifarm AB 01/02/2011 500 mg Film-coated tablet 120 EU/1/00/163/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Sweden 03/03/2011

Xeloda Orifarm AS 27/07/2011 500 mg Film-coated tablet 120 EU/1/00/163/002 Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 05/08/2011

Xeloda Orifarm AS 01/09/2011 150 mg Film-coated tablet 60 EU/1/00/163/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 12/09/2011

Xeloda Pharmachim AB

26/09/2011 500 mg Film-coated tablet 120 EU/1/00/163/002 Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, United Kingdom

Sweden 24/10/2011

Xenical 2 Care 4 05/01/2011 120 mg Capsule, hard 42 EU/1/98/071/002 Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 13/01/2011

Xenical 2 Care 4 05/01/2011 120 mg Capsule, hard 84 EU/1/98/071/003 Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Denmark 09/02/2011


Xenical Axicorp Pharma GmbH

23/09/2011 120 mg Capsule, hard 84 EU/1/98/071/003 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Luxembourg, Norway, Portugal, Sweden, The Netherlands, United Kingdom

Germany 28/09/2011

Xenical Elpis Ltd. 03/02/2011 120 mg Capsule, hard 84 EU/1/98/071/003 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Latvia 08/09/2011

Xenical Mediwin Ltd 12/07/2011 120 mg Capsule, hard 84 EU/1/98/071/003 Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Italy 01/08/2011

Xenical Parallell Pharma AB

07/02/2011 120 mg Capsule, hard 84 EU/1/98/071/003 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, The Netherlands, United Kingdom

Sweden 31/03/2011

Xenical Pretium Farm Sp. z o.o.


Poland 23/11/2011

Xenical Pretium Farm Sp. z o.o.


Poland 23/11/2011

Xenical SAIMA Productos Y Servicios S.L.U.

24/04/2011 120 mg Capsule, hard 84 EU/1/98/071/003 United Kingdom Spain 17/05/2011

Xenical STRATHCLYDE PHARMACEUTICALS LTD



01/12/2011


Xeplion CC Pharma 09/11/2011 100 mg Suspension for injection in pre-filled syringe



Germany 16/12/2011

Xeplion CC Pharma 09/11/2011 150 mg Suspension for injection in pre-filled syringe


EU/1/11/672/005 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 16/12/2011

Xeristar BR Pharma International Ltd



Germany 12/05/2011

Xeristar CC Pharma 12/04/2011 30 mg Gastro-resistant capsule, hard


Germany 28/04/2011

Xeristar CC Pharma 12/04/2011 60 mg Gastro-resistant capsule, hard

28 EU/1/04/297/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/04/2011

Xeristar Euro Registratie Collectief BV



The Netherlands

01/06/2011

Xeristar Euro Registratie Collectief BV



The Netherlands

01/06/2011

Xeristar EuroPharma DK



Denmark 26/04/2011

Xeristar EuroPharma DK



Denmark 26/04/2011

Xeristar MedicoPharm AG


98 EU/1/04/297/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 28/03/2011

Xeristar MedicoPharm AG


28 EU/1/04/297/001 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Spain, Sweden, The Netherlands, United Kingdom

Germany 24/03/2011


Xeristar NewNeopharm BV



Denmark 15/06/2011

XGEVA Haemato Pharm AG



Germany 29/09/2011

Xolair Abacus Medicine A/S




Sweden 27/05/2011

Xolair CC Pharma 23/05/2011 150 mg Solution for injection



Germany 27/05/2011

Xolair CC Pharma 23/05/2011 75 mg Solution for injection



Germany 27/05/2011

Xolair Dr Fisher Farma BV


1 vial + 1 ampoule


The Netherlands

14/03/2011

Xolair Medartuum AB 18/02/2011 150 mg Powder and solvent for solution for injection

1 vial + 1 ampoule


Sweden 14/03/2011

Xolair Orifarm AB 03/01/2011 150 mg Powder and solvent for solution for injection

1 vial + 1 ampoule


Sweden 03/03/2011

Xolair Pharma Westen GmbH


10 intermediate packs (1 vial + 1 ampoule)

EU/1/05/319/004 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Sweden, The Netherlands, United Kingdom

Germany 17/03/2011


Yentreve ADL Pharma GmbH


98 EU/1/04/280/004 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, The Netherlands, United Kingdom

Germany 28/06/2011




Germany 28/06/2011




Germany 07/07/2011




Germany 07/07/2011

Yentreve Axicorp Pharma GmbH



Germany 08/09/2011

Yentreve Axicorp Pharma GmbH



Germany 12/10/2011

Yentreve Veron Pharma Vertriebs GmbH


98 EU/1/04/280/008 Austria, Belgium Germany 21/06/2011










Zarzio Medartuum AB 01/07/2011 30 MU (60 MU/ml)

Solution for injection or infusion



Sweden 06/07/2011


Zarzio Medartuum AB 01/07/2011 48 MU (96 MU/ml)

Solution for injection or infusion



Sweden 06/07/2011

Zebinix Emra-Med 14/09/2011 800 mg Tablet 30 EU/1/09/514/017 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/10/2011

Zeffix Delfarma SpZoo

12/08/2011 100 mg Film-coated tablet 28 EU/1/99/114/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Poland 24/08/2011

Zeffix Euro Registratie Collectief BV


The Netherlands

17/11/2011

Zeffix MPT Pharma 16/12/2010 100 mg Film-coated tablet 28 EU/1/99/114/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


31/01/2011

Zeffix MPT Pharma 16/12/2010 100 mg Film-coated tablet 84 EU/1/99/114/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


31/01/2011

Ziagen Orifarm OY 15/03/2011 300 mg Film-coated tablet 60 EU/1/99/112/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Finland 10/05/2011


Zometa Inopha GmbH 08/03/2011 4 mg Concentrate for solution for infusion


The Netherlands

28/03/2011

Zometa Paranova Danmark AS

13/07/2011 4 mg Powder and solvent for solution for infusion

1 vial + 1 ampoule

EU/1/01/176/001 Austria, Belgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 04/08/2011

Zometa Paranova Läkemedel AB

05/07/2011 4 mg Powder and solvent for solution for infusion

1 vial + 1 ampoule


Sweden 02/08/2011

Zonegran Abacus Medicine A/S

12/04/2011 100 mg Capsule, hard 56 EU/1/04/307/004 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/04/2011



Denmark 19/04/2011



Denmark 22/06/2011

Zonegran B&S Healthcare Ltd



30/05/2011

Zonegran Chemilines Ltd 27/04/2010 50 mg Capsule, hard 14 EU/1/04/307/010 Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands


04/10/2011


Zonegran Mediwin Ltd 04/04/2011 50 mg Capsule, hard 14 EU/1/04/307/010 Austria, Belgium, France, Germany, Greece, Italy, Malta, Portugal, Spain, The Netherlands

United Kingdom

11/05/2011

Zonegran Paranova Danmark AS

20/05/2009 100 mg Capsule, hard 98 EU/1/04/307/007 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 20/07/2011

Zonegran STRATHCLYDE PHARMACEUTICALS LTD



24/10/2011




24/10/2011




16/11/2011

Zutectra CC Pharma 22/08/2011 500 IU Solution for injection



Germany 23/08/2011

Zypadhera 2 Care 4 30/09/2010 210 mg Powder and solvent for prolonged release suspension for injection

1 vial + 1 vial + 1 syringe with pre-attached safety needle + 2 safety needles


Denmark 10/03/2011





Denmark 10/03/2011




Denmark 10/03/2011

Zypadhera CC Pharma 15/12/2011 300 mg Powder and solvent for prolonged release suspension for injection


EU/1/08/479/002 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 19/12/2011

Zypadhera CC Pharma 15/12/2011 405 mg Powder and solvent for prolonged release suspension for injection


EU/1/08/479/003 Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 20/12/2011

Zypadhera Haemato Pharm AG

26/08/2011 210 mg Powder and solvent for prolonged release suspension for injection



Germany 13/09/2011






Germany 13/09/2011





Germany 13/09/2011

Zypadhera Kohlpharma GmbH



EU/1/08/479/002 Lithuania Germany 05/10/2011

Zypadhera Kohlpharma GmbH



EU/1/08/479/003 Lithuania Germany 05/10/2011

Zypadhera Medcor Pharmaceuticals BV



EU/1/08/479/002 Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden, United Kingdom

The Netherlands

07/06/2011


Zypadhera Orifarm AS 19/09/2011 300 mg Powder and solvent for prolonged release suspension for injection



Denmark 04/10/2011




Denmark 04/10/2011




Denmark 04/11/2011

Zyprexa Abacus Medicine A/S

14/01/2011 7.5 mg Coated tablet 28 EU/1/96/022/011 Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Malta, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Denmark 19/01/2011

Zyprexa ADL Pharma GmbH

30/05/2011 5 mg Coated tablet 28 EU/1/96/022/004 Austria, Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Malta, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 18/07/2011



Germany 18/07/2011



Germany 18/07/2011




Germany 18/07/2011

Zyprexa BB Farma s.r.l.

14/02/2011 10 mg Coated tablet 28 EU/1/96/022/009 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 09/03/2011



Germany 09/03/2011



Germany 09/03/2011



Germany 09/03/2011



Germany 10/03/2011



Germany 10/03/2011




Germany 10/03/2011


14/02/2011 5 mg Coated tablet 70 EU/1/96/022/030 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 10/03/2011


21/02/2011 2.5 mg Coated tablet 28 EU/1/96/022/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/03/2011



Germany 11/03/2011



Germany 11/03/2011



Germany 11/03/2011



10/03/2011 7.5 mg Coated tablet 70 EU/1/96/022/031 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway,Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 25/03/2011



Germany 25/03/2011



Germany 25/03/2011



Germany 25/03/2011



Germany 29/03/2011



Germany 29/03/2011



15/03/2011 20 mg Coated tablet 28 EU/1/96/022/014 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/03/2011



Germany 29/03/2011

Zyprexa CC Pharma 15/08/2011 2.5 mg Coated tablet 98 EU/1/96/022/035 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 22/08/2011

Zyprexa CC Pharma 16/08/2011 10 mg Coated tablet 98 EU/1/96/022/038 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 22/08/2011


Germany 22/08/2011


Germany 22/08/2011

Zyprexa CC Pharma 16/08/2011 7.5 mg Coated tablet 98 EU/1/96/022/037 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 22/08/2011

Zyprexa ChemVet Pharma ApS

08/04/2011 7.5 mg Coated tablet 56 EU/1/96/022/006 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 16/06/2011


27/07/2011 20 mg Coated tablet 28 EU/1/96/022/014 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 04/08/2011



Denmark 16/08/2011



Denmark 05/08/2011



Denmark 16/08/2011


Zyprexa Clear Pharmacy

20/12/2010 2.5 mg Coated tablet 28 EU/1/96/022/002 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Malta, Norway, Poland, Portugal, Romania, Spain, Sweden, The Netherlands, United Kingdom


11/01/2011

Zyprexa Docpharm GmbH&CoKGaA

03/05/2011 10 mg Coated tablet 98 EU/1/96/022/038 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/05/2011



Germany 06/07/2011


03/05/2011 2.5 mg Coated tablet 98 EU/1/96/022/035 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 17/05/2011



Germany 17/05/2011


03/05/2011 7.5 mg Coated tablet 98 EU/1/96/022/037 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 06/07/2011

Zyprexa Kohlpharma GmbH

19/05/2011 10 mg Coated tablet 98 EU/1/96/022/038 Finland, France, Greece, Italy, Norway, Spain, The Netherlands, United Kingdom

Germany 22/06/2011


19/05/2011 5 mg Coated tablet 98 EU/1/96/022/036 Finland, France, Greece, Italy, Norway, Spain, The Netherlands, United Kingdom

Germany 22/06/2011


01/09/2011 2.5 mg Coated tablet 56 EU/1/96/022/019 Austria, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 29/09/2011


01/09/2011 2.5 mg Coated tablet 98 EU/1/96/022/035 Austria, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 29/09/2011


01/09/2011 7.5 mg Coated tablet 98 EU/1/96/022/037 Finland, France, Greece, Spain, United Kingdom

Germany 29/09/2011


22/09/2011 15 mg Coated tablet 98 EU/1/96/022/039 Austria, Greece, The Netherlands, United Kingdom

Germany 29/09/2011


Zyprexa MPT Pharma 09/06/2011 10 mg Coated tablet 28 EU/1/96/022/009 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


29/06/2011



29/06/2011



27/06/2011

Zyprexa MPT Pharma 09/06/2011 2.5 mg Coated tablet 28 EU/1/96/022/002 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom


27/06/2011



27/06/2011



27/06/2011




29/06/2011



29/06/2011

Zyprexa Omnia Läkemedel AB

14/06/2011 5 mg Coated tablet 28 EU/1/96/022/004 Belgium, France, Greece, Italy, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 26/08/2011

Zyprexa Omnia Läkemedel AB

15/06/2011 10 mg Coated tablet 56 EU/1/96/022/010 Belgium, France, Greece, Italy, Poland, Portugal, Spain, The Netherlands, United Kingdom

Sweden 17/08/2011

Zyprexa Pharma Westen GmbH

14/03/2011 15 mg Coated tablet 98 EU/1/96/022/039 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/04/2011


14/03/2011 2.5 mg Coated tablet 98 EU/1/96/022/035 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/04/2011


14/03/2011 5 mg Coated tablet 98 EU/1/96/022/036 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 07/04/2011

Zyprexa PI-Pharma N.V.

06/01/2011 10 mg Coated tablet 28 EU/1/96/022/009 Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Belgium 08/03/2011

Zyprexa PI-Pharma N.V.

06/01/2011 5 mg Coated tablet 28 EU/1/96/022/004 Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Belgium 08/03/2011


Zyprexa Propharmed GmbH

27/04/2011 15 mg Coated tablet 35 EU/1/96/022/027 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/05/2011



Germany 12/05/2011


27/04/2011 2.5 mg Coated tablet 35 EU/1/96/022/023 Austria, Belgium, Denmark, Finland, France, Greece, Italy, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 12/05/2011



Germany 12/05/2011



Germany 12/05/2011



Germany 12/05/2011



Germany 12/05/2011



Germany 12/05/2011



Germany 25/08/2011



Germany 25/08/2011

Zyprexa Velotab ADL Pharma GmbH


28 EU/1/99/125/002 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 04/07/2011




Germany 04/07/2011




Germany 04/07/2011





Germany 04/07/2011




Germany 12/07/2011




Germany 12/07/2011




Germany 12/07/2011




Germany 12/07/2011

Zyprexa Velotab BB Farma s.r.l.


28 EU/1/99/125/001 Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 15/04/2011




Germany 15/04/2011




Germany 15/04/2011





Germany 15/04/2011




Germany 13/05/2011




Germany 13/05/2011




Germany 13/05/2011




Germany 13/05/2011




Germany 13/05/2011





Germany 13/05/2011




Germany 13/05/2011




Germany 13/05/2011

Zyprexa Velotab CC Pharma 16/08/2011 10 mg Orodispersible tablet


Germany 26/08/2011



Germany 26/08/2011



Germany 26/08/2011



Germany 26/08/2011

Zyprexa Velotab ChemVet Pharma ApS


28 EU/1/99/125/002 Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Denmark 17/08/2011




Denmark 17/08/2011




Denmark 18/08/2011




Denmark 16/08/2011


Zyprexa Velotab Docpharm GmbH&CoKGaA


98 EU/1/99/125/018 Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Spain, Sweden, The Netherlands, United Kingdom

Germany 25/05/2011




Germany 17/05/2011




Germany 17/05/2011




Germany 25/05/2011

Zyprexa Velotab Emra-Med 07/06/2011 10 mg Orodispersible tablet


Germany 20/06/2011

Zyprexa Velotab Emra-Med 25/11/2011 5 mg Orodispersible tablet


Germany 30/11/2011

Zyprexa Velotab Interport Ltd 07/03/2011 20 mg Orodispersible tablet

28 EU/1/99/125/004 Austria, Belgium, France, Germany, Greece, Italy, Portugal, Spain, The Netherlands

United Kingdom

10/03/2011

Zyprexa Velotab Kohlpharma GmbH


98 EU/1/99/125/018 Austria, Belgium, France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 27/04/2011



98 EU/1/99/125/019 Greece, Spain, The Netherlands, United Kingdom

Germany 22/06/2011



98 EU/1/99/125/020 Greece, The Netherlands, United Kingdom Germany 22/06/2011



98 EU/1/99/125/017 France, Greece, Italy, Portugal, Spain, The Netherlands, United Kingdom

Germany 22/06/2011


Zyprexa Velotab MPT Pharma 20/06/2011 10 mg Orodispersible tablet



30/06/2011




30/06/2011




30/06/2011




30/06/2011




30/06/2011

Zyprexa Velotab Pharma Westen GmbH



Germany 08/04/2011

Zyprexa Velotab Pharma Westen GmbH



Germany 08/04/2011



zyprexa velotab Pharma Westen GmbH


98 EU/1/99/125/017 Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Slovak Republic, Spain, Sweden, The Netherlands, United Kingdom

Germany 24/05/2011

Zyprexa Velotab Propharmed GmbH



Germany 08/07/2011




Germany 22/07/2011




Germany 26/07/2011




Germany 26/07/2011




Germany 26/07/2011

Zytiga Haemato Pharm AG

25/11/2011 250 mg Tablet 120 EU/1/11/714/001 Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, The Netherlands, United Kingdom

Germany 29/11/2011

04 october 2012 ema/643088/2012 initial notices for ... · 04 october 2012 . ema/643088/2012 ......

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