buprenorphine: list of nationally authorised medicinal products - … · de/h/2804/001...
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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
12 April 2018 EMA/227734/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): buprenorphine
Procedure No.: PSUSA/00000459/201707
List of nationally authorised medicinal products EMA/227734/2018 Page 2/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Acimaphin 35 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1739/001 73824.00.00 LUYE PHARMA AG DE
Acimaphin 52,5 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1739/002 73825.00.00 LUYE PHARMA AG DE
Acimaphin 70 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1739/003 73826.00.00 LUYE PHARMA AG DE
Acinorphin 35 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1044/001 68760.00.00 LUYE PHARMA AG DE
Acinorphin 52,5 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1044/002 68761.00.00 LUYE PHARMA AG DE
Acinorphin 70 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1044/003 68762.00.00 LUYE PHARMA AG DE
Addictex 0.4 mg sublingual tablets
PT/H/0433/003 MA628/07801 ACTAVIS GROUP PTC EHF. MT
Addictex 2 mg sublingual tablets
PT/H/0433/001 MA628/07802 ACTAVIS GROUP PTC EHF. MT
Addictex 8 mg sublingual tablets
PT/H/0433/002 MA628/07803 ACTAVIS GROUP PTC EHF. MT
Addnok 0.4mg sublingual tablets
SE/H/0929/001 PL 28444/0013 ACTIVASE PHARMACEUTICALS LIMITED
UK
Addnok 2 mg sublingual tablets
SE/H/0929/002 PL 28444/0014 ACTIVASE PHARMACEUTICALS LIMITED
UK
Addnok 8 mg sublingual tablets
SE/H/0929/003 PL 28444/0015 ACTIVASE PHARMACEUTICALS LIMITED
UK
Algesalona 35 microgrammi/h cerotto transdermico
DE/H/5081/001 043588019 MYLAN S.P.A. IT
Algesalona 35 microgrammi/h cerotto transdermico
DE/H/5081/001 043588021 MYLAN S.P.A. IT
Algesalona 35 microgrammi/h cerotto transdermico
DE/H/5081/001 043588033 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/227734/2018 Page 3/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Algesalona 35 microgrammi/h cerotto transdermico
DE/H/5081/001 043588045 MYLAN S.P.A. IT
Algesalona 35 microgrammi/h cerotto transdermico
DE/H/5081/001 043588058 MYLAN S.P.A. IT
Algesalona 35 microgrammi/h cerotto transdermico
DE/H/5081/001 043588060 MYLAN S.P.A. IT
Algesalona 35 microgrammi/h cerotto transdermico
DE/H/5081/001 043588072 MYLAN S.P.A. IT
Algesalona 52,5 microgrammi/h cerotto transdermico
DE/H/5081/002 043588084 MYLAN S.P.A. IT
Algesalona 52,5 microgrammi/h cerotto transdermico
DE/H/5081/002 043588096 MYLAN S.P.A. IT
Algesalona 52,5 microgrammi/h cerotto transdermico
DE/H/5081/002 043588108 MYLAN S.P.A. IT
Algesalona 52,5 microgrammi/h cerotto transdermico
DE/H/5081/002 043588110 MYLAN S.P.A. IT
Algesalona 52,5 microgrammi/h cerotto transdermico
DE/H/5081/002 043588122 MYLAN S.P.A. IT
Algesalona 52,5 microgrammi/h cerotto transdermico
DE/H/5081/002 043588134 MYLAN S.P.A. IT
Algesalona 52,5 microgrammi/h cerotto transdermico
DE/H/5081/002 043588146 MYLAN S.P.A. IT
Algesalona 70 microgrammi/h cerotto transdermico
DE/H/5081/003 043588159 MYLAN S.P.A. IT
List of nationally authorised medicinal products EMA/227734/2018 Page 4/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Algesalona 70 microgrammi/h cerotto transdermico
DE/H/5081/003 043588161 MYLAN S.P.A. IT
Algesalona 70 microgrammi/h cerotto transdermico
DE/H/5081/003 043588173 MYLAN S.P.A. IT
Algesalona 70 microgrammi/h cerotto transdermico
DE/H/5081/003 043588185 MYLAN S.P.A. IT
Algesalona 70 microgrammi/h cerotto transdermico
DE/H/5081/003 043588197 MYLAN S.P.A. IT
Algesalona 70 microgrammi/h cerotto transdermico
DE/H/5081/003 043588209 MYLAN S.P.A. IT
Algesalona 70 microgrammi/h cerotto transdermico
DE/H/5081/003 043588211 MYLAN S.P.A. IT
Astec 35 Mikrogramm/h Transdermales Pflaster
DE/H/1739/001 1-29773 GEBRO PHARMA GMBH AT
Astec 52,5 Mikrogramm/h Transdermales Pflaster
DE/H/1739/002 1-29772 GEBRO PHARMA GMBH AT
Astec 70 Mikrogramm/h Transdermales Pflaster
DE/H/1739/003 1-29771 GEBRO PHARMA GMBH AT
Bugnanto 10 mikrog/time depotplaster
DE/H/4045/002 13-9923 SANDOZ A/S NO
Bugnanto 20 mikrogram/time depotplaster
DE/H/4045/004 13-9924 SANDOZ A/S NO
Bugnanto 5 mikrog/time depotplaster
DE/H/4045/001 13-9922 SANDOZ A/S NO
BUNONDOL, 0,2 mg, tabletki podjęzykowe
not available R/3517 WARSZAWSKIE ZAKLADY FARMACEUTYCZNE POLFA S.A.
PL
BUNONDOL, 0,3 mg/ml, roztwór do wstrzykiwań
not available R/3516 WARSZAWSKIE ZAKLADY FARMACEUTYCZNE POLFA S.A.
PL
List of nationally authorised medicinal products EMA/227734/2018 Page 5/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUNONDOL, 0,4 mg, tabletki podjęzykowe
not available R/3518 WARSZAWSKIE ZAKLADY FARMACEUTYCZNE POLFA S.A.
PL
Bunorfin 2 mg tabletki podjęzykowe
SE/H/0928/002 17917 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
PL
Bunorfin 8 mg tabletki podjęzykowe
SE/H/0928/003 17918 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
PL
Bunov 10 microgram/h transdermal patch
DE/H/4394/002 PL 25258/0179 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Bunov 20 microgram/h transdermal patch
DE/H/4394/003 PL 25258/0180 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Bunov 5 microgram/h transdermal patch
DE/H/4394/001 PL 25258/0178 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Bupacal 10 Mikrogramm/h - transdermales Pflaster
DE/H/4045/002 136890 HEXAL PHARMA GMBH AT
Bupacal 15 Mikrogramm/h - transdermales Pflaster
DE/H/4045/003 136892 HEXAL PHARMA GMBH AT
Bupacal 20 Mikrogramm/h - transdermales Pflaster
DE/H/4045/004 136893 HEXAL PHARMA GMBH AT
Bupacal 5 Mikrogramm/h - transdermales Pflaster
DE/H/4045/001 136889 HEXAL PHARMA GMBH AT
Bupainx 10 mikrogramu/h transdermální náplast
DE/H/4045/002 65/097/16-C SANDOZ S.R.O. CZ
Bupainx 15 mikrogramů/h transdermální náplast
DE/H/4045/003 65/098/16-C SANDOZ S.R.O. CZ
Bupainx 20 mikrogramů/h transdermální náplast
DE/H/4045/004 65/099/16-C SANDOZ S.R.O. CZ
Bupainx 35 mikrogramů/h transdermální náplast
DE/H/4515/001 65/310/16-C SANDOZ S.R.O. CZ
Bupainx 5 mikrogramů/h transdermální náplast
DE/H/4045/001 65/096/16-C SANDOZ S.R.O. CZ
List of nationally authorised medicinal products EMA/227734/2018 Page 6/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupainx 52,5 mikrogramů/h transdermální náplast
DE/H/4515/002 65/311/16-C SANDOZ S.R.O. CZ
Bupainx 70 mikrogramů/h transdermální náplast
DE/H/4515/003 65/312/16-C SANDOZ S.R.O. CZ
Bupalster 10 Mikrogramm/Stunde Transdermales Pflaster
not available 98142.0000 AET, DE DE
Bupalster 20 Mikrogramm/Stunde Transdermales Pflaster
not available 98143.00.00 AET, DE DE
Bupalster 5 Mikrogramm/Stunde Transdermales Pflaster
not available 98141.00.00 AET, DE DE
Bupan 10 Mikrogramm/Stunde Transdermales Pflaster
not available 98139.00.00 AET, DE DE
Bupan 20 Mikrogramm/Stunde Transdermales Pflaster
not available 98140.00.00 AET, DE DE
Bupan 5 Mikrogramm/Stunde Transdermales Pflaster
not available 98138.00.00 AET, DE DE
Bupeaze 35 micrograms/h Transdermal Patches
DE/H/5077/001 PL 08553/0544 DR. REDDY'S LABORATORIES (UK) LTD.
UK
Bupeaze 52.5 micrograms/h Transdermal Patches
DE/H/5077/002 PL 08553/0545 DR. REDDY'S LABORATORIES (UK) LTD.
UK
Bupeaze 70 micrograms/h Transdermal Patches
DE/H/5077/003 PL 08553/0546 DR. REDDY'S LABORATORIES (UK) LTD.
UK
Bupensan 2 mg poliežuvines tabletes
DE/H/2804/001 LT/1/11/2694/003 G.L. PHARMA GMBH LT
Bupensan 2 mg poliežuvinės tabletės
DE/H/2804/001 LT/1/11/2694/001 G.L. PHARMA GMBH LT
Bupensan 2 mg poliežuvinės tabletės
DE/H/2804/001 LT/1/11/2694/002 G.L. PHARMA GMBH LT
Bupensan 2 mg poliežuvinės tabletės
DE/H/2804/001 LT/1/11/2694/004 G.L. PHARMA GMBH LT
List of nationally authorised medicinal products EMA/227734/2018 Page 7/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupensan 2 mg poliežuvinės tabletės
DE/H/2804/001 LT/1/11/2694/013 G.L. PHARMA GMBH LT
Bupensan 2 mg Sublingualtabletten
not available 87801.00.00 G.L. PHARMA GMBH DE
Bupensan 2 mg tabletes lietošanai zem mēles
DE/H/2804/001 11-0331 G.L. PHARMA GMBH LV
Bupensan 2 mg-Sublingualtabletten
not available 1-29844 G.L. PHARMA GMBH AT
Bupensan 4 mg poliežuvinės tabletės
DE/H/2804/002 LT/1/11/2694/005 G.L. PHARMA GMBH LT
Bupensan 4 mg poliežuvinės tabletės
DE/H/2804/002 LT/1/11/2694/006 G.L. PHARMA GMBH LT
Bupensan 4 mg poliežuvinės tabletės
DE/H/2804/002 LT/1/11/2694/007 G.L. PHARMA GMBH LT
Bupensan 4 mg poliežuvinės tabletės
DE/H/2804/002 LT/1/11/2694/008 G.L. PHARMA GMBH LT
Bupensan 4 mg poliežuvinės tabletės
DE/H/2804/002 LT/1/11/2694/014 G.L. PHARMA GMBH LT
Bupensan 4 mg Sublingualtabletten
not available 87802.00.00 G.L. PHARMA GMBH DE
Bupensan 4 mg tabletes lietošanai zem mēles
DE/H/2804/002 11-0332 G.L. PHARMA GMBH LV
Bupensan 4 mg-Sublingualtabletten
not available 1-29845 G.L. PHARMA GMBH AT
Bupensan 8 mg poliežuvinės tabletės
DE/H/2804/003 LT/1/11/2694/009 G.L. PHARMA GMBH LT
Bupensan 8 mg poliežuvinės tabletės
DE/H/2804/003 LT/1/11/2694/010 G.L. PHARMA GMBH LT
Bupensan 8 mg poliežuvinės tabletės
DE/H/2804/003 LT/1/11/2694/011 G.L. PHARMA GMBH LT
Bupensan 8 mg poliežuvinės tabletės
DE/H/2804/003 LT/1/11/2694/012 G.L. PHARMA GMBH LT
Bupensan 8 mg poliežuvinės tabletės
DE/H/2804/003 LT/1/11/2694/015 G.L. PHARMA GMBH LT
Bupensan 8 mg Sublingualtabletten
not available 87803.00.00 G.L. PHARMA GMBH DE
List of nationally authorised medicinal products EMA/227734/2018 Page 8/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupensan 8 mg tabletes lietošanai zem mēles
DE/H/2804/003 11-0333 G.L. PHARMA GMBH LV
Bupensan 8 mg-Sublingualtabletten
not available 1-29846 G.L. PHARMA GMBH AT
Bupensan, 2 mg keelealused tabletid
DE/H/2804/001 752711 G.L. PHARMA GMBH EE
Bupensan, 4 mg keelealused tabletid
DE/H/2804/002 752811 G.L. PHARMA GMBH EE
Bupensan, 8 mg keelealused tabletid
DE/H/2804/003 752611 G.L. PHARMA GMBH EE
Buphin, depotplastre DE/H/4491/002 56292 TEVA DENMARK A/S DK Buphin, depotplastre DE/H/4491/003 56293 TEVA DENMARK A/S DK Buphin, depotplastre DE/H/4491/001 56291 TEVA DENMARK A/S DK Buplab 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4809/001 98390.00.00 AET, DE DE
Buplab 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4809/002 98391.00.00 AET, DE DE
Buplab 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4809/003 98392.00.00 AET, DE DE
Buplast 35 micrograms/h transdermal patch
DE/H/5081/001 PL 04569/1570 GENERICS [UK] LIMITED UK
Buplast 52.5 micrograms/h transdermal patch
DE/H/5081/002 PL 04569/1571 GENERICS [UK] LIMITED UK
Buplast 70 micrograms/h transdermal patch
DE/H/5081/003 PL 04569/1572 GENERICS [UK] LIMITED UK
Bupramyl 10 micrograms/hour transdermal patch
DE/H/4492/002 PL 04569/1635 GENERICS [UK] LIMITED UK
Bupramyl 20 micrograms/hour transdermal patch
DE/H/4492/003 PL 04569/1636 GENERICS [UK] LIMITED UK
Bupramyl 5 micrograms/hour transdermal patch
DE/H/4492/001 PL 04569/1634 GENERICS [UK] LIMITED UK
List of nationally authorised medicinal products EMA/227734/2018 Page 9/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupre - 1 A Pharma 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4451/001 95181.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4515/001 95761.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4451/002 95182.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4515/002 95762.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster
DE/H/4046/002 91345.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 7 Tage 15 Mikrogramm/Stunde transdermales Pflaster
DE/H/4046/003 91346.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster
DE/H/4046/004 91347.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4046/001 91344.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4451/003 95183.00.00 1 A PHARMA GMBH DE
Bupre - 1 A Pharma 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4515/003 95763.00.00 1 A PHARMA GMBH DE
Buprefarm 10 mikrog/tunti depotlaastari
DE/H/4424/002 33330 ORIFARM GENERICS A/S FI
Buprefarm 10 mikrogram/time depotplaster
SE/H/1630/002 15-10646 ORIFARM GENERICS A/S NO
Buprefarm 10 mikrogram/timme depotplåster
DE/H/4424/002 52813 ORIFARM GENERICS A/S SE
List of nationally authorised medicinal products EMA/227734/2018 Page 10/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprefarm 20 mikrog/tunti depotlaastari
DE/H/4424/003 33331 ORIFARM GENERICS A/S FI
Buprefarm 20 mikrogram/time depotplaster
SE/H/1630/003 15-10647 ORIFARM GENERICS A/S NO
Buprefarm 20 mikrogram/timme depotplåster
DE/H/4424/003 52814 ORIFARM GENERICS A/S SE
Buprefarm 5 mikrog/tunti depotlaastari
DE/H/4424/001 33329 ORIFARM GENERICS A/S FI
Buprefarm 5 mikrogram/time depotplaster
SE/H/1630/001 15-10645 ORIFARM GENERICS A/S NO
Buprefarm 5 mikrogram/timme depotplåster
DE/H/4424/001 52812 ORIFARM GENERICS A/S SE
Buprefarm, depotplastre DE/H/4424/001 55790 ORIFARM GENERICS A/S DK Buprefarm, depotplastre DE/H/4424/002 55791 ORIFARM GENERICS A/S DK Buprefarm, depotplastre DE/H/4424/003 55792 ORIFARM GENERICS A/S DK Bupre-HEXAL 1 x wöchentlich 10 Mikrogramm/Stunde transdermales Pflaster
DE/H/4684/002 97149.00.00 HEXAL AG DE
Bupre-HEXAL 1 x wöchentlich 20 Mikrogramm/Stunde transdermales Pflaster
DE/H/4684/003 97150.00.00 HEXAL AG DE
Bupre-HEXAL 1 x wöchentlich 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4684/001 97148.00.00 HEXAL AG DE
Bupre-HEXAL 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/5083/001 93496.00.00 HEXAL AG DE
Bupre-HEXAL 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4514/001 95758.00.00 HEXAL AG DE
List of nationally authorised medicinal products EMA/227734/2018 Page 11/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupre-HEXAL 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/5083/002 93497.00.00 HEXAL AG DE
Bupre-HEXAL 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4514/002 95759.00.00 HEXAL AG DE
Bupre-HEXAL 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster
DE/H/4045/002 91341.00.00 HEXAL AG DE
Bupre-HEXAL 7 Tage 15 Mikrogramm/Stunde transdermales Pflaster
DE/H/4045/003 91342.00.00 HEXAL AG DE
Bupre-HEXAL 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster
DE/H/4045/004 91343.00.00 HEXAL AG DE
Bupre-HEXAL 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4045/001 91340.00.00 HEXAL AG DE
Bupre-HEXAL 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/5083/003 93498.00.00 HEXAL AG DE
Bupre-HEXAL 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4514/003 95760.00.00 HEXAL AG DE
Bupremyl 10 mikrogram/time depotplaster
DE/H/4492/002 15-10774 MYLAN AB NO
Bupremyl 10 mikrogram/timme depotplåster
DE/H/4492/002 53183 MYLAN AB SE
Bupremyl 10 mikrogrammaa/tunti depotlaastari
DE/H/4492/002 33552 MYLAN AB FI
Bupremyl 10 míkrógrömm/klst. forðaplástur
DE/H/4492/002 IS/1/16/092/02 MYLAN AB IS
List of nationally authorised medicinal products EMA/227734/2018 Page 12/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupremyl 20 mikrogram/time depotplaster
DE/H/4492/003 15-10775 MYLAN AB NO
Bupremyl 20 mikrogram/timme depotplåster
DE/H/4492/003 53184 MYLAN AB SE
Bupremyl 20 mikrogrammaa/tunti depotlaastari
DE/H/4492/003 33553 MYLAN AB FI
Bupremyl 20 míkrógrömm/klst. forðaplástur
DE/H/4492/003 IS/1/16/092/03 MYLAN AB IS
Bupremyl 5 mikrogram/time depotplaster
DE/H/4492/001 15-10773 MYLAN AB NO
Bupremyl 5 mikrogram/timme depotplåster
DE/H/4492/001 53182 MYLAN AB SE
Bupremyl 5 mikrogrammaa/tunti depotlaastari
DE/H/4492/001 33551 MYLAN AB FI
Bupremyl 5 míkrógrömm/klst. forðaplástur
DE/H/4492/001 IS/1/16/092/01 MYLAN AB IS
Bupremyl, depotplastre DE/H/4492/001 56298 MYLAN AB DK Bupremyl, depotplastre DE/H/4492/002 56299 MYLAN AB DK Bupremyl, depotplastre DE/H/4492/003 56300 MYLAN AB DK Buprenaddict 0,4 mg Sublingualtabletten
UK/H/1941/003 79920.00.00 HEXAL AG DE
Buprenaddict 2 mg Sublingualtabletten
UK/H/1941/001 79921.00.00 HEXAL AG DE
Buprenaddict 8 mg Sublingualtabletten
UK/H/1941/002 79922.00.00 HEXAL AG DE
BUPRENAL VIOGEN 0,4 mg, υπογλώσσια δισκία
UK/H/1918/001 61440/10-9-2010 VIOGEN PHARMACEUTICALS GR
BUPRENAL VIOGEN 2 mg, υπογλώσσια δισκία
UK/H/1918/002 61441/10-9-2010 VIOGEN PHARMACEUTICALS GR
List of nationally authorised medicinal products EMA/227734/2018 Page 13/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENAL VIOGEN 8 mg, υπογλώσσια δισκία
UK/H/1918/003 61442/10-9-2010 VIOGEN PHARMACEUTICALS GR
Buprenocan 35 Mikrogramm/h – transdermales Pflaster
DE/H/4514/001 137017 HEXAL PHARMA GMBH AT
Buprenocan 52,5 Mikrogramm/h – transdermales Pflaster
DE/H/4514/002 137018 HEXAL PHARMA GMBH AT
Buprenocan 70 Mikrogramm/h – transdermales Pflaster
DE/H/4514/003 137019 HEXAL PHARMA GMBH AT
Buprenoratiopharm 52,5 Mikrogramm /Stunde Transdermales Pflaster
DE/H/5078/002 93482.00.00 RATIOPHARM GMBH DE
Buprenoratiopharm 7 Tage 10 Mikrogramm/Stunde Transdermales Pflaster
DE/H/4491/002 95463.00.00 RATIOPHARM GMBH DE
Buprenoratiopharm 7 Tage 20 Mikrogramm/Stunde Transdermales Pflaster
DE/H/4491/003 95464.00.00 RATIOPHARM GMBH DE
Buprenoratiopharm 7 Tage 5 Mikrogramm/Stunde Transdermales Pflaster
DE/H/4491/001 95462.00.00 RATIOPHARM GMBH DE
Buprenoratiopharm 70 Mikrogramm /Stunde Transdermales Pflaster
DE/H/5078/003 93483.00.00 RATIOPHARM GMBH DE
Buprenorfin Actavis 2 mg, sublinguala resoribletter
PT/H/0433/001 44728 ACTAVIS GROUP PTC EHF. SE
Buprenorfin Actavis 8 mg, sublinguala resoribletter
PT/H/0433/003 44729 ACTAVIS GROUP PTC EHF. SE
Buprenorfin Alkaloid 0,4 mg sublingvalne tablete
not available HR-H-997185485 ALKALOID D.O.O. HR
Buprenorfin Alkaloid 2 mg sublingvalne tablete
not available HR-H-005987004 ALKALOID D.O.O. HR
Buprenorfin Alkaloid 8 mg sublingvalne tablete
not available HR-H-790349338 ALKALOID D.O.O. HR
List of nationally authorised medicinal products EMA/227734/2018 Page 14/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORFIN ALKALOID-INT 0,4 mg podjezične tablete
UK/H/1918/001 H/09/00318/001 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 0,4 mg podjezične tablete
UK/H/1918/001 H/09/00318/002 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 0,4 mg podjezične tablete
UK/H/1918/001 H/09/00318/003 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 2 mg podjezične tablete
UK/H/1918/002 H/09/00318/004 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 2 mg podjezične tablete
UK/H/1918/002 H/09/00318/005 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 2 mg podjezične tablete
UK/H/1918/002 H/09/00318/006 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 8 mg podjezične tablete
UK/H/1918/003 H/09/00318/007 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 8 mg podjezične tablete
UK/H/1918/003 H/09/00318/008 ALKALOID-INT D.O.O. SI
BUPRENORFIN ALKALOID-INT 8 mg podjezične tablete
UK/H/1918/003 H/09/00318/009 ALKALOID-INT D.O.O. SI
Buprenorfin Mylan 35 mikrogramů/h transdermální náplast
DE/H/5081/001 65/062/16-C GENERICS [UK] LIMITED CZ
Buprenorfin Mylan 52,5 mikrogramů/h transdermální náplast
DE/H/5081/002 65/063/16-C GENERICS [UK] LIMITED CZ
Buprenorfin Mylan 70 mikrogramů/h transdermální náplast
DE/H/5081/003 65/064/16-C GENERICS [UK] LIMITED CZ
Buprenorfin Pliva 35 mikrograma/h transdermalni flaster
DE/H/5078/001 93481.00.00 RATIOPHARM GMBH DE
Buprenorfin Pliva 52,5 mikrograma/h transdermalni flaster
DE/H/5078/002 HR-H-025680475 PLIVA HRVATSKA D.O.O. HR
List of nationally authorised medicinal products EMA/227734/2018 Page 15/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfin Pliva 70 mikrograma/h transdermalni flaster
DE/H/5078/003 HR-H-809849704 PLIVA HRVATSKA D.O.O. HR
Buprenorfin Sandoz 2 mg sublingvalne tablete
/ UP/I-530-09/12-01/160 SANDOZ D.O.O. HR
Buprenorfin Sandoz 8 mg sublingvalne tablete
/ UP/I-530-09/12-01/161 SANDOZ D.O.O. HR
Buprenorfina Actavis PT/H/0433/003 5436050, 6068 ACTAVIS GROUP PTC EHF. PT Buprenorfina Actavis PT/H/0433/001 5436076, 6100 ACTAVIS GROUP PTC EHF. PT Buprenorfina Actavis PT/H/0433/002 5436118, 6126 ACTAVIS GROUP PTC EHF. PT Buprenorfină Alkaloid 0,4 mg, comprimate sublinguale
UK/H/1918/001 2084/2009/03 ALKALOID-INT D.O.O. RO
Buprenorfină Alkaloid 2 mg, comprimate sublinguale
UK/H/1918/002 2085/2009/03 ALKALOID-INT D.O.O. RO
Buprenorfină Alkaloid 2 mg, comprimate sublinguale
UK/H/1918/002 2085/2009/01 ALKALOID-INT D.O.O. RO
Buprenorfină Alkaloid 8 mg, comprimate sublinguale
UK/H/1918/003 2086/2009/02 ALKALOID-INT D.O.O. RO
Buprenorfină Alkaloid 8 mg, comprimate sublinguale
UK/H/1918/003 2086/2009/03 ALKALOID-INT D.O.O. RO
Buprenorfina Andrómaco 35 microgramos/hora parche transdérmico EFG
not available 80068 ANDRÓMACO PHARMA S.L. ES
Buprenorfina Andrómaco 35 microgramos/hora parche transdérmico EFG
not available 80068 ANDRÓMACO PHARMA S.L. ES
Buprenorfina Andrómaco 52,5 microgramos/hora parche transdérmico EFG
not available 80067 ANDRÓMACO PHARMA S.L. ES
Buprenorfina Andrómaco 52,5 microgramos/hora parche transdérmico EFG
not available 80067 ANDRÓMACO PHARMA S.L. ES
Buprenorfina Andrómaco 70 microgramos/hora parche transdérmico EFG
not available 80069 ANDRÓMACO PHARMA S.L. ES
List of nationally authorised medicinal products EMA/227734/2018 Page 16/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Andrómaco 70 microgramos/hora parche transdérmico EFG
not available 80069 ANDRÓMACO PHARMA S.L. ES
Buprenorfina Aristo 35 microgramas/hora adesivo transdérmico
PT/H/1382/001 5674916 ARISTO PHARMA IBERIA, S.L.
PT
Buprenorfina Aristo 35 microgramas/hora adesivo transdérmico
PT/H/1382/001 5674924 ARISTO PHARMA IBERIA, S.L.
PT
Buprenorfina Aristo 35 microgramos/hora parche transdérmico EFG
PT/H/1382/001 80669 ARISTO PHARMA IBERIA, S.L.
ES
Buprenorfina Aristo 52,5 microgramas/hora adesivo transdérmico
PT/H/1382/002 5674940 ARISTO PHARMA IBERIA, S.L.
PT
Buprenorfina Aristo 52,5 microgramas/hora adesivo transdérmico
PT/H/1382/002 5674957 ARISTO PHARMA IBERIA, S.L.
PT
Buprenorfina Aristo 52,5 microgramos/hora parche transdérmico EFG
PT/H/1382/002 80670 ARISTO PHARMA IBERIA, S.L.
ES
Buprenorfina Aristo 70 microgramas/hora adesivo transdérmico
PT/H/1382/003 5675145 ARISTO PHARMA IBERIA, S.L.
PT
Buprenorfina Aristo 70 microgramas/hora adesivo transdérmico
PT/H/1382/003 5675137 ARISTO PHARMA IBERIA, S.L.
PT
Buprenorfina Aristo 70 microgramos/hora parche transdérmico EFG
PT/H/1382/003 80671 ARISTO PHARMA IBERIA, S.L.
ES
Buprenorfina Aurovitas 35 microgramas/h, sistema transdérmico
DE/H/1738/001 5442546 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 35 microgramas/h, sistema transdérmico
DE/H/1738/001 5450424 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 17/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Aurovitas 35 microgramas/h, sistema transdérmico
DE/H/1738/001 5353610 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 35 microgramas/h, sistema transdérmico
DE/H/1738/001 5353628 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 35 microgramas/h, sistema transdérmico
DE/H/1738/001 5353636 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 35 microgramas/h, sistema transdérmico
DE/H/1738/001 5353644 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 52,5 microgramas/h, sistema transdérmico
DE/H/1738/002 5442553 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 52,5 microgramas/h, sistema transdérmico
DE/H/1738/002 5450432 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 52,5 microgramas/h, sistema transdérmico
DE/H/1738/002 5353651 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 52,5 microgramas/h, sistema transdérmico
DE/H/1738/002 5353669 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 52,5 microgramas/h, sistema transdérmico
DE/H/1738/002 5353677 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 52,5 microgramas/h, sistema transdérmico
DE/H/1738/002 5353701 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 70 microgramas/h, sistema transdérmico
DE/H/1738/003 5442561 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 70 microgramas/h, sistema transdérmico
DE/H/1738/003 5450440 AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 18/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Aurovitas 70 microgramas/h, sistema transdérmico
DE/H/1738/003 5353719 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 70 microgramas/h, sistema transdérmico
DE/H/1738/003 5353727 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 70 microgramas/h, sistema transdérmico
DE/H/1738/003 5353735 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Aurovitas 70 microgramas/h, sistema transdérmico
DE/H/1738/003 5353743 AUROVITAS UNIPESSOAL, LDA.
PT
Buprenorfina Azevedos 2 mg comprimidos sublinguais
not available 5138268 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Buprenorfina Azevedos 2 mg comprimidos sublinguais
not available 5138250 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Buprenorfina Azevedos 8 mg comprimidos sublinguais
not available 5138300 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Buprenorfina Azevedos 8 mg comprimidos sublinguais
not available 5138276 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 19/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 5680605 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 5680913 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 35 microgramas/h adesivo transdérmico
DE/H/5082/001 DE/H/5082/001 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 5681135 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 20/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 5681127 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 52,5 microgramas/h adesivo transdérmico
DE/H/5082/002 DE/H/5082/002 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 5680939 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 21/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 5680921 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
Buprenorfina Ciclum 70 microgramas/h adesivo transdérmico
DE/H/5082/003 DE/H/5082/003 CICLUM FARMA UNIPESSOAL LDA.
PT
BUPRENORFINA EURO-LABOR 35 microgramas/h, adesivo transdérmico
DE/H/0308/001 5662671 GRÜNENTHAL S.A. PT
BUPRENORFINA EURO-LABOR 35 microgramas/h, adesivo transdérmico
DE/H/0308/001 5662705 GRÜNENTHAL S.A. PT
BUPRENORFINA EURO-LABOR 52,5 microgramas/h, adesivo transdérmico
DE/H/0308/002 5662713 GRÜNENTHAL S.A. PT
BUPRENORFINA EURO-LABOR 52,5 microgramas/h, adesivo transdérmico
DE/H/0308/002 5662721 GRÜNENTHAL S.A. PT
BUPRENORFINA EURO-LABOR 70 microgramas/h, adesivo transdérmico
DE/H/0308/003 5662739 GRÜNENTHAL S.A. PT
BUPRENORFINA EURO-LABOR 70 microgramas/h, adesivo transdérmico
DE/H/0308/003 5662747 GRÜNENTHAL S.A. PT
Buprenorfina Generis 0,4 mg comprimidos sublinguais
not available 5592134 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 0,4 mg comprimidos sublinguais
not available 5592142 GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 22/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Generis 0,4 mg comprimidos sublinguais
not available 5592134 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 0,4 mg comprimidos sublinguais
not available 5592142 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 2 mg comprimidos sublinguais
not available 5588777 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 2 mg comprimidos sublinguais
not available 5588777 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 4 mg comprimidos sublinguais
not available 11/H/0253/003 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 4 mg comprimidos sublinguais
not available 11/H/0253/003 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 6 mg comprimidos sublinguais
not available 11/H/0253/004 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 6 mg comprimidos sublinguais
not available 11/H/0253/004 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 8 mg comprimidos sublinguais
not available 5588801 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Generis 8 mg comprimidos sublinguais
not available 5588801 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 0,4 mg comprimido sublingual
not available 5553201 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 0,4 mg comprimido sublingual
not available 5553219 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 0,4 mg comprimido sublingual
not available 5553201 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 0,4 mg comprimido sublingual
not available 5553219 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 2 mg comprimido sublingual
not available 5553227 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 2 mg comprimido sublingual
not available 5553235 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 2 mg comprimido sublingual
not available 5553227 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 2 mg comprimido sublingual
not available 5553235 GENERIS FARMACÊUTICA, S.A.
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 23/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Labesfal 8 mg comprimido sublingual
not available 5553243 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 8 mg comprimido sublingual
not available 5553250 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 8 mg comprimido sublingual
not available 5553243 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Labesfal 8 mg comprimido sublingual
not available 5553250 GENERIS FARMACÊUTICA, S.A.
PT
Buprenorfina Liovite 8 mg comprimidos sublinguais
not available 5296363 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Buprenorfina Liovite 8 mg comprimidos sublinguais
not available 5296355 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Buprenorfina Molteni 2 mg compresse sublinguali
SE/H/0928/002 040325060 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Buprenorfina Molteni 2 mg compresse sublinguali
SE/H/0928/002 040325058 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Buprenorfina Molteni 2 mg compresse sublinguali
SE/H/0928/002 040325045 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Buprenorfina Molteni 8 mg compresse sublinguali
SE/H/0928/003 040325072 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Buprenorfina Molteni 8 mg compresse sublinguali
SE/H/0928/003 040325096 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Buprenorfina Molteni 8 mg compresse sublinguali
SE/H/0928/003 040325084 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
IT
Buprenorfina Mylan 35 microgramos/hora parche transdérmico EFG
DE/H/5081/001 80534 MYLAN PHARMACEUTICALS S.L.
ES
List of nationally authorised medicinal products EMA/227734/2018 Page 24/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Mylan 52,5 microgramos/hora parche transdérmico EFG
DE/H/5081/002 80535 MYLAN PHARMACEUTICALS S.L.
ES
Buprenorfina Mylan 70 microgramos/hora parche transdérmico EFG
DE/H/5081/003 80536 MYLAN PHARMACEUTICALS S.L.
ES
Buprenorfina Mylan Generics 0,4 mg compresse sublinguali
UK/H/1949/001 039747023 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 0,4 mg compresse sublinguali
UK/H/1949/001 039747035 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 0,4 mg compresse sublinguali
UK/H/1949/001 039747011 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 0,4 mg compresse sublinguali
UK/H/1949/001 039747047 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 2 mg compresse sublinguali
UK/H/1949/002 039747062 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 2 mg compresse sublinguali
UK/H/1949/002 039747074 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 2 mg compresse sublinguali
UK/H/1949/002 039747050 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 2 mg compresse sublinguali
UK/H/1949/002 039747086 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 8 mg compresse sublinguali
UK/H/1949/003 039747100 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 8 mg compresse sublinguali
UK/H/1949/003 039747112 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 8 mg compresse sublinguali
UK/H/1949/003 039747098 MYLAN S.P.A. IT
Buprenorfina Mylan Generics 8 mg compresse sublinguali
UK/H/1949/003 039747124 MYLAN S.P.A. IT
Buprenorfina ratiopharm 0,4 mg comprimidos sublinguais
PT/H/0448/001 5436225 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 25/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina ratiopharm 0,4 mg comprimidos sublinguais
PT/H/0448/001 5436217 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 2 mg comprimidos sublinguais
PT/H/0448/001 5436233 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 2 mg comprimidos sublinguais
PT/H/0448/001 5436241 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 35 microgramas/h adesivo transdérmico
DE/H/5078/001 5671110 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 35 microgramas/h adesivo transdérmico
DE/H/5078/001 5671128 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 35 microgramos/hora parche transdérmico EFG
DE/H/5079/001 80620 RATIOPHARM ESPANA SA ES
Buprenorfina ratiopharm 52,5 microgramas/h adesivo transdérmico
DE/H/5078/002 5673207 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 52,5 microgramas/h adesivo transdérmico
DE/H/5078/002 5673173 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 52,5 microgramos/hora parche transdérmico EFG
DE/H/5079/002 80621 RATIOPHARM ESPANA SA ES
Buprenorfina ratiopharm 70 microgramas/h adesivo transdérmico
DE/H/5078/003 5673215 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina ratiopharm 70 microgramos/hora parche transdérmico EFG
DE/H/5079/003 80622 RATIOPHARM ESPANA SA ES
Buprenorfina ratiopharm 8 mg comprimidos sublinguais
PT/H/0448/002 5436266 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 26/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina ratiopharm 8 mg comprimidos sublinguais
PT/H/0448/002 5436258 RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA
PT
Buprenorfina Sandoz 20 microgramos/hora parche transdérmico
DE/H/4045/004 80943 SANDOZ FARMACÉUTICA, S.A.
ES
Buprenorfina Sandoz 35 microgramos/hora parche transdérmico EFG
DE/H/5083/001 80596 SANDOZ FARMACÉUTICA, S.A.
ES
Buprenorfina Sandoz 5 microgramos/hora parche transdérmico
DE/H/4045/001 80942 SANDOZ FARMACÉUTICA, S.A.
ES
Buprenorfina Sandoz 52,5 microgramos/hora parche transdérmico EFG
DE/H/5083/002 80597 SANDOZ FARMACÉUTICA, S.A.
ES
Buprenorfina Sandoz 70 microgramos/hora parche transdérmico EFG
DE/H/5083/003 80598 SANDOZ FARMACÉUTICA, S.A.
ES
Buprenorfina Semanal STADA 10 microgramos/hora parche transdérmico
DE/H/4397/002 82.066 LABORATORIO STADA, S.L. ES
Buprenorfina Semanal STADA 20 microgramos/hora parche transdérmico
DE/H/4397/003 82.065 LABORATORIO STADA, S.L. ES
Buprenorfina Semanal STADA 5 microgramos/hora parche transdérmico
DE/H/4397/001 82.064 LABORATORIO STADA, S.L. ES
Buprenorfina Sigillata 0,4 mg comprimidos sublinguais
PT/H/0447/003 5436134 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Sigillata 0,4 mg comprimidos sublinguais
PT/H/0447/003 5436142 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Sigillata 2 mg comprimidos sublinguais
PT/H/0447/001 5436167 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Sigillata 2 mg comprimidos sublinguais
PT/H/0447/001 5436159 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 27/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Sigillata 8 mg comprimidos sublinguais
PT/H/0447/002 5436209 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Sigillata 8 mg comprimidos sublinguais
PT/H/0447/002 5436175 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina STADA 35 microgramos/hora parche transdérmico 96 horas EFG
DE/H/5082/001 80.460 LABORATORIO STADA, S.L. ES
Buprenorfina STADA 52,5 microgramos/hora parche transdérmico 96 horas EFG
DE/H/5082/002 80.461 LABORATORIO STADA, S.L. ES
Buprenorfina STADA 70 microgramos/hora parche transdérmico 96 horas EFG
DE/H/5082/003 80.462 LABORATORIO STADA, S.L. ES
Buprenorfina SUN 2 mg compresse sublinguali
NL/H/3356/001 040643013 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Buprenorfina SUN 2 mg compresse sublinguali
NL/H/3356/001 040643025 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Buprenorfina SUN 8 mg compresse sublinguali
NL/H/3356/002 040643037 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Buprenorfina SUN 8 mg compresse sublinguali
NL/H/3356/002 040643049 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Buprenorfina Teva 0,4 mg comprimidos sublinguais
PT/H/1288/001 5659248 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Teva 0,4 mg comprimidos sublinguais
PT/H/1288/001 5659255 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Teva 10 microgramos/hora parche transdérmico
DE-H-4491-001-003 81491 TEVA PHARMA S.L.U ES
Buprenorfina Teva 2 mg comprimidos sublinguais
PT/H/1288/002 5659271 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Teva 2 mg comprimidos sublinguais
PT/H/1288/002 5659263 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Teva 20 microgramos/hora parche transdérmico
DE-H-4491-001-003 81492 TEVA PHARMA S.L.U ES
List of nationally authorised medicinal products EMA/227734/2018 Page 28/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfina Teva 35 microgramos/hora parche transdérmico EFG
DE/H/5078/001 80609 TEVA PHARMA S.L.U ES
Buprenorfina Teva 35 mikrogramów/godzinę, system transdermalny
DE/H/5078/001 23165 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Buprenorfina Teva 5 microgramos/hora parche transdérmico
DE/H/4491/001 81490 TEVA PHARMA S.L.U ES
Buprenorfina Teva 52,5 microgramos/hora parche transdérmico EFG
DE/H/5078/002 80610 TEVA PHARMA S.L.U ES
Buprenorfina Teva 52,5 mikrogramów/godzinę, system transdermalny
DE/H/5078/002 23166 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Buprenorfina Teva 70 microgramos/hora parche transdérmico EFG
DE/H/5078/003 80611 TEVA PHARMA S.L.U ES
Buprenorfina Teva 70 mikrogramów/godzinę, system transdermalny
DE/H/5078/003 23167 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Buprenorfina Teva 8 mg comprimidos sublinguais
PT/H/1288/003 5659321 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Teva 8 mg comprimidos sublinguais
PT/H/1288/003 5659339 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Buprenorfina Teva, 10 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4491/002 23945 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Buprenorfina Teva, 20 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4491/003 23946 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Buprenorfina Teva, 5 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4491/001 23944 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
List of nationally authorised medicinal products EMA/227734/2018 Page 29/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfine CF 10 microgram/uur, pleister voor transdermaal gebruik
DE/H/4397/002 RVG 117219 CENTRAFARM B.V. NL
Buprenorfine CF 20 microgram/uur, pleister voor transdermaal gebruik
DE/H/4397/003 RVG 117220 CENTRAFARM B.V. NL
Buprenorfine CF 35 microgram/uur, pleister voor transdermaal gebruik
DE/H/5082/001 RVG 117392 CENTRAFARM B.V. NL
Buprenorfine CF 5 microgram/uur, pleister voor transdermaal gebruik
DE/H/4397/001 RVG 117218 CENTRAFARM B.V. NL
Buprenorfine CF 52,5 microgram/uur, pleister voor transdermaal gebruik
DE/H/5082/002 RVG 117393 CENTRAFARM B.V. NL
Buprenorfine CF 70 microgram/uur, pleister voor transdermaal gebruik
DE/H/5082/003 RVG 117394 CENTRAFARM B.V. NL
Buprenorfine Glenmark 10 microgram/uur 7 dagen pleister voor transdermaal gebruik
DE/H/4394/002 RVG 117216 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Buprenorfine Glenmark 20 microgram/uur 7 dagen pleister voor transdermaal gebruik
DE/H/4394/003 RVG 117217 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Buprenorfine Glenmark 5 microgram/uur 7 dagen pleister voor transdermaal gebruik
DE/H/4394/001 RVG 117215 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Buprenorfine Mylan 0,4 mg, tabletten voor sublinguaal gebruik
UK/H/1949/001 RVG 102351 MYLAN B.V. NL
Buprenorfine Mylan 2 mg, tabletten voor sublinguaal gebruik
UK/H/1949/002 RVG 102355 MYLAN B.V. NL
List of nationally authorised medicinal products EMA/227734/2018 Page 30/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfine Mylan 8 mg, tabletten voor sublinguaal gebruik
UK/H/1949/003 RVG 102356 MYLAN B.V. NL
Buprenorfine Pleister Mylan 10 microgram/uur, pleister voor transdermaal gebruik
DE/H/4492/002 RVG 117660 MYLAN B.V. NL
Buprenorfine Pleister Mylan 20 microgram/uur, pleister voor transdermaal gebruik
DE/H/4492/003 RVG 117661 MYLAN B.V. NL
Buprenorfine Pleister Mylan 5 microgram/uur, pleister voor transdermaal gebruik
DE/H/4492/001 RVG 117659 MYLAN B.V. NL
Buprenorfine Ranbaxy 35 microgram/uur, pleister voor transdermaal gebruik
DE/H/1739/001 RVG 103490 RANBAXY UK LTD NL
Buprenorfine Ranbaxy 52,5 microgram/uur, pleister voor transdermaal gebruik
DE/H/1739/002 RVG 103491 RANBAXY UK LTD NL
Buprenorfine Ranbaxy 70 microgram/uur, pleister voor transdermaal gebruik
DE/H/1739/003 RVG 103492 RANBAXY UK LTD NL
Buprenorfine Sandoz 10 microgram/uur, pleister voor transdermaal gebruik
DE/H/4045/002 RVG 114800 SANDOZ B.V. NL
Buprenorfine Sandoz 15 microgram/uur, pleister voor transdermaal gebruik
DE/H/4045/003 RVG 114801 SANDOZ B.V. NL
Buprenorfine Sandoz 20 microgram/uur, pleister voor transdermaal gebruik
DE/H/4045/004 RVG 114802 SANDOZ B.V. NL
Buprenorfine Sandoz 35 microgram/uur pleisters voor transdermaal gebruik
DE/H/4515/001 BE499502 SANDOZ N.V. BE
Buprenorfine Sandoz 35 microgram/uur pleisters voor transdermaal gebruik
DE/H/4515/001 BE499502 SANDOZ N.V. BE
List of nationally authorised medicinal products EMA/227734/2018 Page 31/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfine Sandoz 35 microgram/uur, pleister voor transdermaal gebruik
DE/H/5083/001 RVG 120051 SANDOZ B.V. NL
Buprenorfine Sandoz 5 microgram/uur, pleister voor transdermaal gebruik
DE/H/4045/001 RVG 114799 SANDOZ B.V. NL
Buprenorfine Sandoz 52,5 microgram/uur pleisters voor transdermaal gebruik
DE/H/4515/002 BE499511 SANDOZ N.V. BE
Buprenorfine Sandoz 52,5 microgram/uur pleisters voor transdermaal gebruik
DE/H/4515/002 BE499511 SANDOZ N.V. BE
Buprenorfine Sandoz 52,5 microgram/uur, pleister voor transdermaal gebruik
DE/H/5083/002 RVG 120052 SANDOZ B.V. NL
Buprenorfine Sandoz 70 microgram/uur pleisters voor transdermaal gebruik
DE/H/4515/003 BE499520 SANDOZ N.V. BE
Buprenorfine Sandoz 70 microgram/uur pleisters voor transdermaal gebruik
DE/H/4515/003 BE499520 SANDOZ N.V. BE
Buprenorfine Sandoz 70 microgram/uur, pleister voor transdermaal gebruik
DE/H/5083/003 RVG 120053 SANDOZ B.V. NL
Buprenorfine Sandoz pleister 10 microgram/uur, pleister voor transdermaal gebruik
DE/H/4684/002 RVG 118910 SANDOZ B.V. NL
Buprenorfine Sandoz pleister 20 microgram/uur, pleister voor transdermaal gebruik
DE/H/4684/003 RVG 118911 SANDOZ B.V. NL
Buprenorfine Sandoz pleister 5 microgram/uur, pleister voor transdermaal gebruik
DE/H/4684/001 RVG 118909 SANDOZ B.V. NL
Buprenorfine Sandoz Wekelijks 10 microgram/uur pleister voor transdermaal gebruik
DE/H/4045/002 BE496044 SANDOZ N.V. BE
List of nationally authorised medicinal products EMA/227734/2018 Page 32/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorfine Sandoz Wekelijks 15 microgram/uur pleister voor transdermaal gebruik
DE/H/4045/003 BE496071 SANDOZ N.V. BE
Buprenorfine Sandoz Wekelijks 20 microgram/uur pleister voor transdermaal gebruik
DE/H/4045/004 BE496080 SANDOZ N.V. BE
Buprenorfine Sandoz Wekelijks 5 microgram/uur pleister voor transdermaal gebruik
DE/H/4045/001 BE496026 SANDOZ N.V. BE
Buprenorfine SUN 2 mg tabletten voor sublinguaal gebruik
NL/H/3356/001 RVG 106350 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
NL
Buprenorfine SUN 8 mg tabletten voor sublinguaal gebruik
NL/H/3356/002 106355 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
NL
Buprenorfine Teva 10 microgram/uur, pleister voor transdermaal gebruik
DE/H/4491/002 RVG 117630 TEVA NEDERLAND B.V. NL
Buprenorfine Teva 20 microgram/uur, pleister voor transdermaal gebruik
DE/H/4491/003 RVG 117631 TEVA NEDERLAND B.V. NL
Buprenorfine Teva 35 microgram/uur, pleister voor transdermaal gebruik
DE/H/5078/001 RVG 116173 TEVA NEDERLAND B.V. NL
Buprenorfine Teva 5 microgram/uur, pleister voor transdermaal gebruik
DE/H/4491/001 RVG 117629 TEVA NEDERLAND B.V. NL
Buprenorfine Teva 52,5 microgram/uur, pleister voor transdermaal gebruik
DE/H/5078/002 RVG 116174 TEVA NEDERLAND B.V. NL
Buprenorfine Teva 70 microgram/uur, pleister voor transdermaal gebruik
DE/H/5078/003 RVG 116175 TEVA NEDERLAND B.V. NL
List of nationally authorised medicinal products EMA/227734/2018 Page 33/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin – 1 A Pharma 35 microgram/hour transdermal patch
DE/H/4515/001 MA939/06101 1 A PHARMA GMBH MT
Buprenorphin "Stada" 35 mikrogram/t depotplaster
DE/H/5082/001 54760 STADA ARZNEIMITTEL AG DK
Buprenorphin "Stada" 52,5 rnikrogram/t depotplaster
DE/H/5082/002 54761 STADA ARZNEIMITTEL AG DK
Buprenorphin "Stada" 70 mikrogram/t depotplaster
DE/H/5082/003 54762 STADA ARZNEIMITTEL AG DK
Buprenorphin ”Actavis”, resoribletter, sublinguale
PT/H/0433/002 47336 ACTAVIS GROUP PTC EHF. DK
Buprenorphin ”Actavis”, resoribletter, sublinguale
PT/H/0433/003 47337 ACTAVIS GROUP PTC EHF. DK
Buprenorphin 1A Pharma 10 Mikrogramm/h - transdermales Pflaster
DE/H/4046/002 136896 1A PHARMA GMBH AT
Buprenorphin 1A Pharma 15 Mikrogramm/h - transdermales Pflaster
DE/H/4046/003 136897 1A PHARMA GMBH AT
Buprenorphin 1A Pharma 20 Mikrogramm/h - transdermales Pflaster
DE/H/4046/004 136898 1A PHARMA GMBH AT
Buprenorphin 1A Pharma 35 Mikrogramm/h – transdermales Pflaster
DE/H/4515/001 137020 1A PHARMA GMBH AT
Buprenorphin 1A Pharma 5 Mikrogramm/h - transdermales Pflaster
DE/H/4046/001 136895 1A PHARMA GMBH AT
Buprenorphin 1A Pharma 52,5 Mikrogramm/h – transdermales Pflaster
DE/H/4515/002 137021 1A PHARMA GMBH AT
Buprenorphin 1A Pharma 70 Mikrogramm/h – transdermales Pflaster
DE/H/4515/003 137022 1A PHARMA GMBH AT
Buprenorphin AbZ 2 mg Sublingualtabletten
PT/H/0447/001 82795.00.00 ABZ-PHARMA GMBH DE
List of nationally authorised medicinal products EMA/227734/2018 Page 34/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin AbZ 35 Mikrogramm/Stunde Transdermales Pflaster
DE/H/5079/001 93484.00.00 RATIOPHARM GMBH DE
Buprenorphin AbZ 52,5 Mikrogramm/Stunde Transdermales Pflaster
DE/H/5079/002 93485.00.00 RATIOPHARM GMBH DE
Buprenorphin AbZ 70 Mikrogramm/Stunde Transdermales Pflaster
DE/H/5079/003 93486.00.00 RATIOPHARM GMBH DE
Buprenorphin Acino 35 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1737/001 73818.00.00 LUYE PHARMA AG DE
Buprenorphin Acino 52,5 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1737/002 73819.00.00 LUYE PHARMA AG DE
Buprenorphin Acino 70 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1737/003 73820.00.00 LUYE PHARMA AG DE
Buprenorphin AL 10 Mikrogramm/Stunde transdermales Pflaster
DE/H/4397/002 94861.00.00 ALIUD PHARMA GMBH DE
Buprenorphin AL 20 Mikrogramm/Stunde transdermales Pflaster
DE/H/4397/003 94862.00.00 ALIUD PHARMA GMBH DE
Buprenorphin AL 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/5082/001 93493.00.00 ALIUD PHARMA GMBH DE
Buprenorphin AL 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4397/001 94860.00.00 ALIUD PHARMA GMBH DE
Buprenorphin AL 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/5082/002 93494.00.00 ALIUD PHARMA GMBH DE
Buprenorphin AL 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/5082/003 93495.00.00 ALIUD PHARMA GMBH DE
List of nationally authorised medicinal products EMA/227734/2018 Page 35/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin Aristo® 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4267/001 93896.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Buprenorphin Aristo® 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4267/002 93897.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Buprenorphin Aristo® 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster
DE/H/4393/002 94849.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Buprenorphin Aristo® 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster
DE/H/4393/003 94850.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Buprenorphin Aristo® 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4393/001 94848.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Buprenorphin Aristo® 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4267/003 93898.00.00 ARISTO PHARMA GMBH (ART 57)
DE
Buprenorphin AWD® Matrix 35 Mikrogramm/h Transdermales Pflaster
not available 88453.00.00 TEVA GMBH DE
Buprenorphin AWD® Matrix 52,5 Mikrogramm/h Transdermales Pflaster
not available 88454.00.00 TEVA GMBH DE
Buprenorphin AWD® Matrix 70 Mikrogramm/h Transdermales Pflaster
not available 88455.00.00 TEVA GMBH DE
Buprenorphin beta 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/5077/001 93476.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin beta 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/5077/002 93477.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin beta 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/5077/003 93478.00.00 BETAPHARM ARZNEIMITTEL GMBH
DE
List of nationally authorised medicinal products EMA/227734/2018 Page 36/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin dura 0,4 mg Sublingualtabletten
UK/H/1949/001 73023.00.00 MYLAN DURA GMBH DE
Buprenorphin dura 2 mg Sublingualtabletten
UK/H/1949/002 73025.00.00 MYLAN DURA GMBH DE
Buprenorphin dura 8 mg Sublingualtabletten
UK/H/1949/003 73028.00.00 MYLAN DURA GMBH DE
Buprenorphin Ethypharm 0,4 mg Sublingualtabletten
not available 81909.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 0,4 mg Sublingualtabletten
not available 81909.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 0,4 mg Sublingualtabletten
not available 81909.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 0,4 mg Sublingualtabletten
not available 81909.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 2 mg Sublingualtabletten
not available 81910.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 2 mg Sublingualtabletten
not available 81910.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 2 mg Sublingualtabletten
not available 81910.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 2 mg Sublingualtabletten
not available 81910.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 8 mg Sublingualtabletten
not available 81911.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 8 mg Sublingualtabletten
not available 81911.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 8 mg Sublingualtabletten
not available 81911.00.00 ETHYPHARM GMBH DE
Buprenorphin Ethypharm 8 mg Sublingualtabletten
not available 81911.00.00 ETHYPHARM GMBH DE
Buprenorphin G.L. 2 mg Sublingualtabletten
DE/H/2804/001 81456.00.00 G.L. PHARMA GMBH DE
Buprenorphin G.L. 4 mg Sublingualtabletten
DE/H/2804/002 81457.00.00 G.L. PHARMA GMBH DE
Buprenorphin G.L. 8 mg Sublingualtabletten
DE/H/2804/003 81458.00.00 G.L. PHARMA GMBH DE
List of nationally authorised medicinal products EMA/227734/2018 Page 37/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin Generics 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/5081/001 93490.00.00 MYLAN DURA GMBH DE
Buprenorphin Generics 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/5081/002 93491.00.00 MYLAN DURA GMBH DE
Buprenorphin Generics 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/5081/003 93492.00.00 MYLAN DURA GMBH DE
Buprenorphin Glenmark 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/5080/001 93487.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Buprenorphin Glenmark 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/5080/002 93488.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Buprenorphin Glenmark 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster
DE/H/4394/002 94852.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Buprenorphin Glenmark 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster
DE/H/4394/003 94853.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Buprenorphin Glenmark 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4394/001 94851.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Buprenorphin Glenmark 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/5080/003 93489.00.00 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DE
Buprenorphin Hexal 2 mg – Sublingualtabletten
UK/H/1941/001 1-30986 HEXAL PHARMA GMBH AT
Buprenorphin Hexal 8 mg – Sublingualtabletten
UK/H/1941/002 1-30987 HEXAL PHARMA GMBH AT
Buprenorphin Libra-Pharm 3 Tage 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4510/001 95490.00.00 LIBRA-PHARM GMBH DE
List of nationally authorised medicinal products EMA/227734/2018 Page 38/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin Libra-Pharm 3 Tage 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4510/001 2017070185 LIBRA-PHARM GMBH LU
Buprenorphin Libra-Pharm 3 Tage 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4510/002 95491.00.00 LIBRA-PHARM GMBH DE
Buprenorphin Libra-Pharm 3 Tage 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4510/002 2017070186 LIBRA-PHARM GMBH LU
Buprenorphin Libra-Pharm 3 Tage 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4510/003 95492.00.00 LIBRA-PHARM GMBH DE
Buprenorphin Libra-Pharm 3 Tage 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4510/003 2017070187 LIBRA-PHARM GMBH LU
Buprenorphin Libra-Pharm 4 Tage 35 Mikrogramm/Stunde, transdermales Pflaster
DE/H/0308/001 47058.00.00 LIBRA-PHARM GMBH DE
Buprenorphin Libra-Pharm 4 Tage 52,5 Mikrogramm/Stunde, transdermales Pflaster
DE/H/0308/002 47058.01.00 LIBRA-PHARM GMBH DE
Buprenorphin Libra-Pharm 4 Tage 70 Mikrogramm/Stunde, transdermales Pflaster
DE/H/0308/003 47058.02.00 LIBRA-PHARM GMBH DE
Buprenorphin Mylan 7 Tage 10 Mikrogramm/Stunde transdermales Pflaster
DE/H/4492/002 95466.00.00 MYLAN DURA GMBH DE
Buprenorphin Mylan 7 Tage 20 Mikrogramm/Stunde transdermales Pflaster
DE/H/4492/003 95467.00.00 MYLAN DURA GMBH DE
List of nationally authorised medicinal products EMA/227734/2018 Page 39/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin Mylan 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4492/001 95465.00.00 MYLAN DURA GMBH DE
Buprenorphin PUREN 0,4 mg Sublingualtabletten
PT/H/0433/003 85618.00.00 PUREN PHARMA GMBH & CO. KG
DE
Buprenorphin PUREN 2 mg Sublingualtabletten
PT/H/433/001 82774.00.00 PUREN PHARMA GMBH & CO. KG
DE
Buprenorphin PUREN 8 mg Sublingualtabletten
PT/H/433/002 82775.00.00 PUREN PHARMA GMBH & CO. KG
DE
Buprenorphin ratiopharm 10 Mikrogramm/h Transdermales Pflaster
DE/H/4491/002 137262 RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH
AT
Buprenorphin ratiopharm 2 mg Sublingualtabletten
PT/H/1288/002 136436 TEVA B.V AT
Buprenorphin ratiopharm 20 Mikrogramm/h Transdermales Pflaster
DE/H/4491/003 137263 RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH
AT
Buprenorphin ratiopharm 35 Mikrogramm/h Transdermales Pflaster
DE/H/5078/001 136754 TEVA B.V AT
Buprenorphin ratiopharm 5 Mikrogramm/h Transdermales Pflaster
DE/H/4491/001 137261 RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH
AT
Buprenorphin ratiopharm 52,5 Mikrogramm/h Transdermales Pflaster
DE/H/5078/002 136755 TEVA B.V AT
Buprenorphin ratiopharm 70 Mikrogramm/h Transdermales Pflaster
DE/H/5078/003 136756 TEVA B.V AT
Buprenorphin ratiopharm 8 mg Sublingualtabletten
PT/H/1288/003 136437 TEVA B.V AT
Buprenorphin Sanofi 2 mg Sublingualtabletten
DE/H/2547/001 79243.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Buprenorphin Sanofi 2 mg Sublingualtabletten
DE/H/2547/001 79243.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Buprenorphin Sanofi 2 mg Sublingualtabletten
DE/H/2547/001 79243.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
List of nationally authorised medicinal products EMA/227734/2018 Page 40/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin Sanofi 2 mg Sublingualtabletten
DE/H/2547/001 79243.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Buprenorphin Sanofi 8 mg Sublingualtabletten
DE/H/2547/002 79244.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Buprenorphin Sanofi 8 mg Sublingualtabletten
DE/H/2547/002 79244.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Buprenorphin Sanofi 8 mg Sublingualtabletten
DE/H/2547/002 79244.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Buprenorphin Sanofi 8 mg Sublingualtabletten
DE/H/2547/002 79244.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
Buprenorphin STADA 35 Mikrogramm/h transdermales Pflaster
DE/H/5082/001 136736 STADA ARZNEIMITTEL GMBH
AT
Buprenorphin STADA 52,5 Mikrogramm/h transdermales Pflaster
DE/H/5082/002 136737 STADA ARZNEIMITTEL GMBH
AT
Buprenorphin STADA 70 Mikrogramm/h Transdermales Pflaster
DE/H/5082/003 136738 STADA ARZNEIMITTEL GMBH
AT
Buprenorphin Tiefenbacher 10 Mikrogramm/Stunde Transdermales Pflaster
not available 98136.0000 AET, DE DE
Buprenorphin Tiefenbacher 20 Mikrogramm/Stunde Transdermales Pflaster
not available 98137.00.00 AET, DE DE
Buprenorphin Tiefenbacher 5 Mikrogramm/Stunde Transdermales Pflaster
not available 98135.00.00 AET, DE DE
Buprenorphin-Actavis 35 Mikrogramm/Stunde Transdermales Pflaster
DE/H/3646/001 87904.00.00 ACTAVIS GROUP PTC EHF. DE
Buprenorphin-Actavis 52,5 Mikrogramm/Stunde Transdermales Pflaster
DE/H/3646/002 87905.00.00 ACTAVIS GROUP PTC EHF. DE
Buprenorphin-Actavis 70 Mikrogramm/Stunde Transdermales Pflaster
DE/H/3646/003 87906.00.00 ACTAVIS GROUP PTC EHF. DE
List of nationally authorised medicinal products EMA/227734/2018 Page 41/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine "Orion" 10 microg/h depotplastre
DK/H/2602/02/DC 15-10986 ORION CORPORATION NO
Buprenorphine "Orion", depotplastre
DK/H/2602/001 57048 ORION CORPORATION DK
Buprenorphine "Orion", depotplastre
DK/H/2602/002 57049 ORION CORPORATION DK
Buprenorphine "Orion", depotplastre
DK/H/2602/003 57050 ORION CORPORATION DK
Buprenorphine "Sandoz" UK/H/1940/002 46123 SANDOZ A/S DK Buprenorphine "Sandoz" UK/H/1940/001 46122 SANDOZ A/S DK Buprenorphine "Stada", depotplastre 10 mikrogram/time
DE/H/4397/002 55788 STADA ARZNEIMITTEL AG DK
Buprenorphine "Stada", depotplastre 20 mikrogram/time
DE/H/4397/003 55789 STADA ARZNEIMITTEL AG DK
Buprenorphine "Stada", depotplastre 5 mikrogram/time
DE/H/4397/001 55787 STADA ARZNEIMITTEL AG DK
Buprenorphine ”Bluefish”, sublinguale resoribletter
SE/H/0930/001 44857 BLUEFISH PHARMACEUTICALS AB
DK
Buprenorphine ”Bluefish”, sublinguale resoribletter
SE/H/0930/002 44858 BLUEFISH PHARMACEUTICALS AB
DK
Buprenorphine ”Bluefish”, sublinguale resoribletter
SE/H/0930/003 44859 BLUEFISH PHARMACEUTICALS AB
DK
Buprenorphine ”Bluefish”, sublinguale resoribletter
SE/H/0930/001 44857 BLUEFISH PHARMACEUTICALS AB
DK
Buprenorphine ”Bluefish”, sublinguale resoribletter
SE/H/0930/002 44858 BLUEFISH PHARMACEUTICALS AB
DK
Buprenorphine ”Bluefish”, sublinguale resoribletter
SE/H/0930/003 44859 BLUEFISH PHARMACEUTICALS AB
DK
Buprenorphine ”Orifarm”, resoibletter, sublinguale
NO/H/0175/001 45760 ORIFARM GENERICS A/S DK
Buprenorphine ”Orifarm”, resoibletter, sublinguale
NO/H/0175/002 45761 ORIFARM GENERICS A/S DK
Buprenorphine ”Teva” PT/H/0447/003 47333 TEVA DENMARK A/S DK Buprenorphine ”Teva” PT/H/0447/001 47332 TEVA DENMARK A/S DK
List of nationally authorised medicinal products EMA/227734/2018 Page 42/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine 0.4 mg sublingual tablets
not available PL 40378/0092 APTIL PHARMA LIMITED UK
Buprenorphine 0.4 mg sublingual tablets
UK/H/1918/001 PL 06934/0102 ETHYPHARM UK
Buprenorphine 0.4 mg sublingual tablets
UK/H/1918/001 PL 06934/0102 ETHYPHARM UK
Buprenorphine 0.4 mg sublingual tablets
UK/H/1918/001 PL 06934/0102 ETHYPHARM UK
Buprenorphine 0.4 mg sublingual tablets
UK/H/1941/003 PL 04416/0953 SANDOZ LTD UK
Buprenorphine 0.4mg Sublingual Tablets
PT/H/0433/001 PL 30306/0376 ACTAVIS GROUP PTC EHF. UK
Buprenorphine 2 mg Sublingual Tablets
UK/H/1827/002 PA1333/003/002 MORNINGSIDE HEALTHCARE LTD
IE
Buprenorphine 2 mg sublingual tablets
not available PL 40378/0093 APTIL PHARMA LIMITED UK
Buprenorphine 2 mg sublingual tablets
UK/H/1918/002 PL 06934/0103 ETHYPHARM UK
Buprenorphine 2 mg sublingual tablets
UK/H/1918/002 PL 06934/0103 ETHYPHARM UK
Buprenorphine 2 mg sublingual tablets
UK/H/1918/002 PL 06934/0103 ETHYPHARM UK
Buprenorphine 2 mg sublingual tablets
UK/H/1941/001 PL 04416/0951 SANDOZ LTD UK
Buprenorphine 2 mg sublingual tablets
UK/H/1949/002 PL 04569/1195 GENERICS [UK] LIMITED UK
Buprenorphine 2 mg Sublingual Tablets
UK/H/1827/002 PL 20117/0119 MORNINGSIDE HEALTHCARE LTD
UK
Buprenorphine 2 mg sublingual tablets
NL/H/3356/001 PL 31750/0043 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
UK
Buprenorphine 200 microgram Sublingual Tablets
UK/H/1944/001 PL 04416/0958 SANDOZ LTD UK
Buprenorphine 2mg Sublingual Tablets
not available PL 00240/0354 THORNTON & ROSS LTD UK
Buprenorphine 2mg Sublingual Tablets
PT/H/0433/002 PL 30306/0327 ACTAVIS GROUP PTC EHF. UK
List of nationally authorised medicinal products EMA/227734/2018 Page 43/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine 400 microgram Sublingual Tablets
UK/H/1944/002 PL 04416/0959 SANDOZ LTD UK
Buprenorphine 8 mg Sublingual Tablets
UK/H/1827/003 PA1333/003/003 MORNINGSIDE HEALTHCARE LTD
IE
Buprenorphine 8 mg sublingual tablets
not available PL 40378/0094 APTIL PHARMA LIMITED UK
Buprenorphine 8 mg sublingual tablets
UK/H/1918/003 PL 06934/0104 ETHYPHARM UK
Buprenorphine 8 mg sublingual tablets
UK/H/1918/003 PL 06934/0104 ETHYPHARM UK
Buprenorphine 8 mg sublingual tablets
UK/H/1918/003 PL 06934/0104 ETHYPHARM UK
Buprenorphine 8 mg sublingual tablets
UK/H/1941/002 PL 04416/0952 SANDOZ LTD UK
Buprenorphine 8 mg sublingual tablets
UK/H/1949/003 PL 04569/1196 GENERICS [UK] LIMITED UK
Buprenorphine 8 mg Sublingual Tablets
UK/H/1827/003 PL 20117/0120 MORNINGSIDE HEALTHCARE LTD
UK
Buprenorphine 8 mg sublingual tablets
NL/H/3356/002 PL 31750/0044 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
UK
Buprenorphine 8mg Sublingual Tablets
not available PL 00240/0355 THORNTON & ROSS LTD UK
Buprenorphine 8mg Sublingual Tablets
PT/H/0433/003 PL 30306/0328 ACTAVIS GROUP PTC EHF. UK
Buprenorphine Actavis 2 mg sublingvaltabletter
PT/H/0433/002 10-7748 ACTAVIS GROUP PTC EHF. NO
Buprenorphine Actavis 2 mg tungurótartöflur
PT/H/0433/001 IS/1/12/065/02 ACTAVIS GROUP PTC EHF. IS
BUPRENORPHINE ACTAVIS 35 MIKROGRAMŮ/H TRANSDERMÁLNÍ NÁPLAST
DE/H/1738/001 65/206/10-C ACTAVIS GROUP PTC EHF. CZ
BUPRENORPHINE ACTAVIS 52,5 MIKROGRAMŮ/H TRANSDERMÁLNÍ NÁPLAST
DE/H/1738/002 65/207/10-C ACTAVIS GROUP PTC EHF. CZ
List of nationally authorised medicinal products EMA/227734/2018 Page 44/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE ACTAVIS 70 MIKROGRAMŮ/H TRANSDERMÁLNÍ NÁPLAST
DE/H/1738/003 65/208/10-C ACTAVIS GROUP PTC EHF. CZ
Buprenorphine Actavis 8 mg sublingvaltabletter
PT/H/0433/003 10-7749 ACTAVIS GROUP PTC EHF. NO
Buprenorphine Actavis 8 mg tungurótartöflur
PT/H/0433/002 IS/1/12/065/03 ACTAVIS GROUP PTC EHF. IS
Buprenorphine Alkaloid 0,4 mg, tabletki podjęzykowe
UK/H/1918/001 16546 ALKALOID-INT D.O.O. PL
BUPRENORPHINE ALKALOID 2 mg sublingvální tablety
UK/H/1918/002 19/735/09-C ALKALOID-INT D.O.O. CZ
Buprenorphine Alkaloid 2 mg, tabletki podjęzykowe
UK/H/1918/002 16547 ALKALOID-INT D.O.O. PL
BUPRENORPHINE ALKALOID 8 mg sublingvální tablety
UK/H/1918/003 19/736/09-C ALKALOID-INT D.O.O. CZ
Buprenorphine Alkaloid 8 mg, tabletki podjęzykowe
UK/H/1918/003 16548 ALKALOID-INT D.O.O. PL
BUPRENORPHINE ARROW 0,4 mg, comprimé sublingual
not available 30 908 ARROW GENERIQUES FR
BUPRENORPHINE ARROW 1 mg, comprimé sublingual
not available 33 931 ARROW GENERIQUES FR
BUPRENORPHINE ARROW 2 mg, comprimé sublingual
not available 30 909 ARROW GENERIQUES FR
BUPRENORPHINE ARROW 4 mg, comprimé sublingual
not available 33 932 ARROW GENERIQUES FR
BUPRENORPHINE ARROW 6 mg, comprimé sublingual
not available 33 933 ARROW GENERIQUES FR
BUPRENORPHINE ARROW 8 mg, comprimé sublingual
not available 30 910 ARROW GENERIQUES FR
BUPRENORPHINE BIOGARAN 0,4 mg, comprimé sublingual
not available 3400938870152 BIOGARAN FR
BUPRENORPHINE BIOGARAN 2 mg, comprimé sublingual
not available 3400938871272 BIOGARAN FR
BUPRENORPHINE BIOGARAN 8 mg, comprimé sublingual
not available 3400938873573 BIOGARAN FR
List of nationally authorised medicinal products EMA/227734/2018 Page 45/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine Bluefish 0,4 mg, sublinguala resoribletter
SE/H/0930/001 42330 BLUEFISH PHARMACEUTICALS AB
SE
Buprenorphine Bluefish 0,4 mg, sublinguala resoribletter
SE/H/0930/001 42330 BLUEFISH PHARMACEUTICALS AB
SE
Buprenorphine Bluefish 2 mg, sublinguala resoribletter
SE/H/0930/002 42331 BLUEFISH PHARMACEUTICALS AB
SE
Buprenorphine Bluefish 2 mg, sublinguala resoribletter
SE/H/0930/002 42331 BLUEFISH PHARMACEUTICALS AB
SE
Buprenorphine Bluefish 8 mg, sublinguala resoribletter
SE/H/0930/003 42332 BLUEFISH PHARMACEUTICALS AB
SE
Buprenorphine Bluefish 8 mg, sublinguala resoribletter
SE/H/0930/003 42332 BLUEFISH PHARMACEUTICALS AB
SE
BUPRENORPHINE CRISTERS 0,4 mg, comprimé sublingual
not available 34009 300 618 3 1 CRISTERS FR
BUPRENORPHINE CRISTERS 0,4 mg, comprimé sublingual
not available 34009 300 618 4 8 CRISTERS FR
BUPRENORPHINE CRISTERS 0,4 mg, comprimé sublingual
not available 34009 300 617 9 4 CRISTERS FR
BUPRENORPHINE CRISTERS 0,4 mg, comprimé sublingual
not available 34009 300 618 0 0 CRISTERS FR
BUPRENORPHINE CRISTERS 0,4 mg, comprimé sublingual
not available 34009 300 618 1 7 CRISTERS FR
BUPRENORPHINE CRISTERS 0,4 mg, comprimé sublingual
not available 34009 300 618 2 4 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 7 4 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 8 1 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 9 8 CRISTERS FR
List of nationally authorised medicinal products EMA/227734/2018 Page 46/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 621 1 1 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 621 2 8 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 621 3 5 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 621 4 2 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 1 6 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 9 2 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 2 3 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 3 0 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 4 7 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 5 4 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 7 8 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 619 8 5 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 0 5 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 1 2 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 2 9 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 3 6 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 5 0 CRISTERS FR
BUPRENORPHINE CRISTERS 2 mg, comprimé sublingual
not available 34009 300 620 6 7 CRISTERS FR
List of nationally authorised medicinal products EMA/227734/2018 Page 47/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 621 7 3 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 621 8 0 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 621 9 7 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 0 3 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 1 0 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 2 7 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 3 4 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 2 6 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 4 1 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 4 0 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 5 8 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 5 7 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 6 4 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 7 1 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 8 8 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 9 5 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 6 5 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 8 9 CRISTERS FR
List of nationally authorised medicinal products EMA/227734/2018 Page 48/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 622 9 6 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 0 2 CRISTERS FR
BUPRENORPHINE CRISTERS 8 mg, comprimé sublingual
not available 34009 300 623 1 9 CRISTERS FR
BUPRENORPHINE EG 0,4 mg, comprimé sublingual
not available NL40990 EG LABO LABORATOIRES EUROGENERICS
FR
BUPRENORPHINE EG 2 mg, comprimé sublingual
not available NL50140 EG LABO LABORATOIRES EUROGENERICS
FR
BUPRENORPHINE EG 8 mg, comprimé sublingual
not available NL50141 EG LABO LABORATOIRES EUROGENERICS
FR
Buprenorphine Ethypharm 0,4 mg resoribletter, sublinguala
DK/H/1374/001 41528 ETHYPHARM SE
BUPRENORPHINE ETHYPHARM 0,4 mg, comprimé sublingual
not available 388 707-3 OU 34009 388 707 3 2
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 0,4 mg, comprimé sublingual
not available 388 709-6 OU 34009 388 709 6 1
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 0,4 mg, comprimé sublingual
not available 388 707-3 OU 34009 388 707 3 2
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 0,4 mg, comprimé sublingual
not available 388 709-6 OU 34009 388 709 6 1
ETHYPHARM FR
BUPRENORPHINE Ethypharm 1 mg, comprimé sublingual
not available 34009 389 604 3 3 ETHYPHARM FR
BUPRENORPHINE Ethypharm 1 mg, comprimé sublingual
not available 34009 389 607 2 3 ETHYPHARM FR
BUPRENORPHINE Ethypharm 1 mg, comprimé sublingual
not available 34009 389 604 3 3 ETHYPHARM FR
BUPRENORPHINE Ethypharm 1 mg, comprimé sublingual
not available 34009 389 607 2 3 ETHYPHARM FR
Buprenorphine Ethypharm 2 mg resoribletter, sublinguala
DK/H/1374/002 41529 ETHYPHARM SE
List of nationally authorised medicinal products EMA/227734/2018 Page 49/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE ETHYPHARM 2 mg, comprimé sublingual
not available 388 717-9 OU 34009 388 717 9 1
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 2 mg, comprimé sublingual
not available 388 718-5 OU 34009 388 718 5 2
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 2 mg, comprimé sublingual
not available 388 717-9 OU 34009 388 717 9 1
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 2 mg, comprimé sublingual
not available 388 718-5 OU 34009 388 718 5 2
ETHYPHARM FR
BUPRENORPHINE Ethypharm 4 mg, comprimé sublingual
not available 34009 389 705 4 8 ETHYPHARM FR
BUPRENORPHINE Ethypharm 4 mg, comprimé sublingual
not available 34009 389 706 0 9 ETHYPHARM FR
BUPRENORPHINE Ethypharm 4 mg, comprimé sublingual
not available 34009 389 705 4 8 ETHYPHARM FR
BUPRENORPHINE Ethypharm 4 mg, comprimé sublingual
not available 34009 389 706 0 9 ETHYPHARM FR
BUPRENORPHINE Ethypharm 6 mg, comprimé sublingual
not available 34009 389 710 8 8 ETHYPHARM FR
BUPRENORPHINE Ethypharm 6 mg, comprimé sublingual
not available 34009 389 711 4 9 ETHYPHARM FR
BUPRENORPHINE Ethypharm 6 mg, comprimé sublingual
not available 34009 389 710 8 8 ETHYPHARM FR
BUPRENORPHINE Ethypharm 6 mg, comprimé sublingual
not available 34009 389 711 4 9 ETHYPHARM FR
Buprenorphine Ethypharm 8 mg resoribletter, sublinguala
DK/H/1374/003 41530 ETHYPHARM SE
BUPRENORPHINE ETHYPHARM 8 mg, comprimé sublingual
not available 388 740-0 OU 34009 388 740 0 6
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 8 mg, comprimé sublingual
not available 388 741-7 OU 34009 388 741 7 4
ETHYPHARM FR
List of nationally authorised medicinal products EMA/227734/2018 Page 50/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE ETHYPHARM 8 mg, comprimé sublingual
not available 388 740-0 OU 34009 388 740 0 6
ETHYPHARM FR
BUPRENORPHINE ETHYPHARM 8 mg, comprimé sublingual
not available 388 741-7 OU 34009 388 741 7 4
ETHYPHARM FR
Buprenorphine Ethypharm, sublinguale resoribletter
DK/H/1374/001 37592 ETHYPHARM DK
Buprenorphine Ethypharm, sublinguale resoribletter
DK/H/1374/002 37593 ETHYPHARM DK
Buprenorphine Ethypharm, sublinguale resoribletter
DK/H/1374/003 37594 ETHYPHARM DK
Buprenorphine G.L. Pharma 2 mg resoriblett, sublingual
DE/H/2804/001 44154 G.L. PHARMA GMBH SE
Buprenorphine G.L. Pharma 4 mg resoriblett, sublingual
DE/H/2804/002 44155 G.L. PHARMA GMBH SE
Buprenorphine G.L. Pharma 8 mg resoriblett, sublingual
DE/H/2804/003 44156 G.L. PHARMA GMBH SE
Buprenorphine Glenmark 10 mikrog/timme depotplåster
DE/H/4394/002 33334 GLENMARK PHARMACEUTICALS EUROPE LIMITED
FI
Buprenorphine Glenmark 10 mikrog/tunti depotlaastari
DE/H/4394/002 33334 GLENMARK PHARMACEUTICALS EUROPE LIMITED
FI
Buprenorphine Glenmark 10 mikrogram/timme depotplåster
DE/H/4394/002 52807 GLENMARK PHARMACEUTICALS EUROPE LIMITED
SE
Buprenorphine Glenmark 20 mikrog/timme depotplåster
DE/H/4394/003 33335 GLENMARK PHARMACEUTICALS EUROPE LIMITED
FI
Buprenorphine Glenmark 20 mikrog/tunti depotlaastari
DE/H/4394/003 33335 GLENMARK PHARMACEUTICALS EUROPE LIMITED
FI
Buprenorphine Glenmark 20 mikrogram/timme depotplåster
DE/H/4394/003 52808 GLENMARK PHARMACEUTICALS EUROPE LIMITED
SE
List of nationally authorised medicinal products EMA/227734/2018 Page 51/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine Glenmark 5 mikrog/timme depotplåster
DE/H/4394/001 33333 GLENMARK PHARMACEUTICALS EUROPE LIMITED
FI
Buprenorphine Glenmark 5 mikrog/tunti depotlaastari
DE/H/4394/001 33333 GLENMARK PHARMACEUTICALS EUROPE LIMITED
FI
Buprenorphine Glenmark 5 mikrogram/timme depotplåster
DE/H/4394/001 52806 GLENMARK PHARMACEUTICALS EUROPE LIMITED
SE
Buprenorphine ''Glenmark'', depotplastre
DE/H/4394/001 55813 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DK
Buprenorphine ''Glenmark'', depotplastre
DE/H/4394/003 55815 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DK
Buprenorphine ''Glenmark'', depotplastre
DE/H/4394/002 55814 GLENMARK PHARMACEUTICALS EUROPE LIMITED
DK
Buprenorphine Hexal 10 mikrog/tunti depotlaastari
DE/H/4684/002 34046 HEXAL A/S FI
Buprenorphine Hexal 20 mikrog/tunti depotlaastari
DE/H/4684/003 34048 HEXAL A/S FI
Buprenorphine Hexal 5 mikrog/tunti depotlaastari
DE/H/4684/001 34047 HEXAL A/S FI
Buprenorphine Hexal, 10 mikrogram/timme depotplåster
DE/H/4684/002 54449 HEXAL A/S SE
Buprenorphine Hexal, 20 mikrogram/timme depotplåster
DE/H/4684/003 54450 HEXAL A/S SE
Buprenorphine Hexal, 5 mikrogram/timme depotplåster
DE/H/4684/001 54448 HEXAL A/S SE
BUPRENORPHINE MYLAN 0,4 mg, comprimé sublingual
not available NL 30905 MYLAN S.A.S FR
Buprenorphine Mylan 0.4 mg sublingual tablets
UK/H/1949/001 PL 20438/0008 GENERICS [UK] LIMITED UK
List of nationally authorised medicinal products EMA/227734/2018 Page 52/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE MYLAN 1 mg, comprimé sublingual
not available NL 33657 MYLAN S.A.S FR
BUPRENORPHINE MYLAN 2 mg, comprimé sublingual
not available NL 30906 MYLAN S.A.S FR
Buprenorphine Mylan 35 Mikrogramm/S transdermales Pflaster
DE/H/5081/001 BE489582 MYLAN BVBA/SPRL BE
BUPRENORPHINE MYLAN 4 mg, comprimé sublingua
not available NL 33658 MYLAN S.A.S FR
BUPRENORPHINE MYLAN 6 mg, comprimé sublingual
not available NL 33659 MYLAN S.A.S FR
BUPRENORPHINE MYLAN 8 mg, comprimé sublingual
not available NL 30907 MYLAN S.A.S FR
Buprenorphine Orifarm 2 mg resoriblett, sublingual
NO/H/0175/001 43164 ORIFARM GENERICS A/S SE
Buprenorphine Orifarm 2 mg sublingvaltablett
NO/H/0175/001 09-7077 ORIFARM GENERICS A/S NO
Buprenorphine Orifarm 8 mg resoriblett, sublingual
NO/H/0175/002 43165 ORIFARM GENERICS A/S SE
Buprenorphine Orifarm 8 mg sublingvaltablett
NO/H/0175/002 09-7078 ORIFARM GENERICS A/S NO
Buprenorphine Orion 10 mikrog/t depotlaastari
DK/H/2602/002 33846 ORION CORPORATION FI
Buprenorphine Orion 10 mikrog/t depotplåster
DK/H/2602/002 33846 ORION CORPORATION FI
Buprenorphine Orion 10 mikrogram/timme depotplåster
DK/H/2602/002 53794 ORION CORPORATION SE
Buprenorphine Orion 20 mikrog/t depotlaastari
DK/H/2602/003 33847 ORION CORPORATION FI
Buprenorphine Orion 20 mikrog/t depotplåster
DK/H/2602/003 33847 ORION CORPORATION FI
Buprenorphine Orion 20 mikrog/time depotplaster
DK/H/2602/003 15-10987 ORION CORPORATION NO
Buprenorphine Orion 20 mikrogram/timme depotplåster
DK/H/2602/003 53795 ORION CORPORATION SE
List of nationally authorised medicinal products EMA/227734/2018 Page 53/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine Orion 5 mikrog/t depotlaastari
DK/H/2602/001 33845 ORION CORPORATION FI
Buprenorphine Orion 5 mikrog/t depotplåster
DK/H/2602/001 33845 ORION CORPORATION FI
Buprenorphine Orion 5 mikrog/time depotplaster
DK/H/2602/001 15-10985 ORION CORPORATION NO
Buprenorphine Orion 5 mikrogram/timme depotplåster
DK/H/2602/001 53793 ORION CORPORATION SE
Buprenorphine ratiopharm 10 mikrog/tunti depotlaastari
DE/H/4491/002 33549 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 10 mikrog/tunti depotlaastari
DE/H/4491/002 33549 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 10 míkrógrömm/klst. forðaplástur
DE/H/4491/002 IS/1/17/008/02 RATIOPHARM GMBH IS
Buprenorphine ratiopharm 20 mikrog/timme depotplåster
DE/H/4491/003 33550 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 20 mikrog/tunti depotlaastari
DE/H/4491/003 33550 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 20 mikrog/tunti depotlaastari
DE/H/4491/003 33550 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 20 mikrog/tunti depotlaastari
DE/H/4491/003 33550 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 20 mikrog/tunti depotlaastari
DE/H/4491/003 33550 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 20 míkrógrömm/klst. forðaplástur
DE/H/4491/003 IS/1/17/008/03 RATIOPHARM GMBH IS
List of nationally authorised medicinal products EMA/227734/2018 Page 54/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine ratiopharm 35 mikrog/t depotlaastari
DE/H/5078/001 32613 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 35 mikrog/t depotplåster
DE/H/5078/001 32613 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 35 míkrógrömm/klst. forðaplástur
DE/H/5078/001 IS/1/17/007/01 RATIOPHARM GMBH IS
Buprenorphine ratiopharm 5 mikrog/timme depotplåster
DE-H-4491-001-003 33548 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 5 mikrog/tunti depotlaastari
DE/H/4491/001 33548 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 5 míkrógrömm/klst. forðaplástur
DE/H/4491/001 IS/1/17/008/01 RATIOPHARM GMBH IS
Buprenorphine ratiopharm 52,5 mikrog/t depotlaastari
DE/H/5078/002 32614 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 52,5 mikrog/t depotplåster
DE/H/5078/002 32614 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 52,5 míkrógrömm/klst. forðaplástur
DE/H/5078/002 IS/1/17/007/02 RATIOPHARM GMBH IS
Buprenorphine ratiopharm 70 mikrog/t depotlaastari
DE/H/5078/003 32615 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 70 mikrog/t depotplåster
DE/H/5078/003 32615 RATIOPHARM GMBH FI
Buprenorphine ratiopharm 70 míkrógrömm/klst. forðaplástur
DE/H/5078/003 IS/1/17/007/03 RATIOPHARM GMBH IS
Buprenorphine Sandoz DE/H/4045/001 53630 SANDOZ A/S DK Buprenorphine Sandoz DE/H/4045/004 53633 SANDOZ A/S DK Buprenorphine Sandoz DE/H/4045/002 53631 SANDOZ A/S DK Buprenorphine Sandoz DE/H/4045/003 53632 SANDOZ A/S DK BUPRENORPHINE SANDOZ 0,4 mg, comprimé sublingual
not available 34009 388 705 0 3 SANDOZ FR
List of nationally authorised medicinal products EMA/227734/2018 Page 55/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE SANDOZ 0,4 mg, comprimé sublingual
not available 34009 388 706 7 1 SANDOZ FR
BUPRENORPHINE SANDOZ 1 mg, comprimé sublingual
not available 34009 389 703 1 9 SANDOZ FR
BUPRENORPHINE SANDOZ 1 mg, comprimé sublingual
not available 34009 389 704 8 7 SANDOZ FR
Buprenorphine Sandoz 10 mikrog/tunti depotlaastari
DE/H/4045/002 32086 SANDOZ A/S FI
Buprenorphine Sandoz 10 mikrogram/timme depotplåster
DE/H/4045/002 50658 SANDOZ A/S SE
Buprenorphine Sandoz 15 mikrog/tunti depotlaastari
DE/H/4045/003 32087 SANDOZ A/S FI
Buprenorphine Sandoz 15 mikrogram/timme depotplåster
DE/H/4045/003 50659 SANDOZ A/S SE
Buprenorphine Sandoz 2 mg resoriblett, sublingual
UK/H/1940/001 43499 SANDOZ A/S SE
Buprenorphine Sandoz 2 mg sublingvaltabletter
UK/H/1940/001 09-7231 SANDOZ A/S NO
BUPRENORPHINE SANDOZ 2 mg, comprimé sublingual
not available 34009 388 715 6 2 SANDOZ FR
BUPRENORPHINE SANDOZ 2 mg, comprimé sublingual
not available 34009 388 716 2 3 SANDOZ FR
Buprenorphine Sandoz 20 mikrog/tunti depotlaastari
DE/H/4045/004 32088 SANDOZ A/S FI
Buprenorphine Sandoz 20 mikrogram/timme depotplåster
DE/H/4045/004 50660 SANDOZ A/S SE
Buprenorphine Sandoz 35 mikrogramov/h transdermálna náplasť
DE/H/4515/001 65/0301/16-S SANDOZ PHARMACEUTICALS D.D.
SK
Buprenorphine Sandoz 35 mikrogramů/h transdermální náplast
DE/H/4451/001 65/077/16-C SANDOZ S.R.O. CZ
List of nationally authorised medicinal products EMA/227734/2018 Page 56/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BUPRENORPHINE SANDOZ 4 mg, comprimé sublingual
not available 34009 389 707 7 7 SANDOZ FR
BUPRENORPHINE SANDOZ 4 mg, comprimé sublingual
not available 34009 389 708 3 8 SANDOZ FR
Buprenorphine Sandoz 5 mikrog/tunti depotlaastari
DE/H/4045/001 32085 SANDOZ A/S FI
Buprenorphine Sandoz 5 mikrogram/timme depotplåster
DE/H/4045/001 50657 SANDOZ A/S SE
Buprenorphine Sandoz 52,5 mikrogramov/h transdermálna náplasť
DE/H/4515/002 65/0302/16-S SANDOZ PHARMACEUTICALS D.D.
SK
Buprenorphine Sandoz 52,5 mikrogramů/h transdermální náplast
DE/H/4451/002 65/078/16-C SANDOZ S.R.O. CZ
BUPRENORPHINE SANDOZ 6 mg, comprimé sublingual
not available 34009 389 712 0 0 SANDOZ FR
BUPRENORPHINE SANDOZ 6 mg, comprimé sublingual
not available 34009 389 713 7 8 SANDOZ FR
Buprenorphine Sandoz 70 mikrogramov/h transdermálna náplasť
DE/H/4515/003 65/0303/16-S SANDOZ PHARMACEUTICALS D.D.
SK
Buprenorphine Sandoz 70 mikrogramů/h transdermální náplast
DE/H/4451/003 65/079/16-C SANDOZ S.R.O. CZ
Buprenorphine Sandoz 8 mg resoriblett, sublingual
UK/H/1940/002 43500 SANDOZ A/S SE
Buprenorphine Sandoz 8 mg sublingvaltabletter
UK/H/1940/002 09-7232 SANDOZ A/S NO
BUPRENORPHINE SANDOZ 8 mg, comprimé sublingual
not available 34009 388 742 3 5 SANDOZ FR
BUPRENORPHINE SANDOZ 8 mg, comprimé sublingual
not available 34009 388 744 6 4 SANDOZ FR
Buprenorphine STADA 10 mikrog/tunti depotlaastari
DE/H/4397/002 33337 STADA ARZNEIMITTEL AG FI
List of nationally authorised medicinal products EMA/227734/2018 Page 57/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine STADA 10 mikrogram/timme depotplåster
DE/H/4397/002 52810 STADA ARZNEIMITTEL AG SE
Buprenorphine STADA 20 mikrog/tunti depotlaastari
DE/H/4397/003 33338 STADA ARZNEIMITTEL AG FI
Buprenorphine STADA 20 mikrogram/timme depotplåster
DE/H/4397/003 52811 STADA ARZNEIMITTEL AG SE
Buprenorphine STADA 5 mikrog/tunti depotlaastari
DE/H/4397/001 33336 STADA ARZNEIMITTEL AG FI
Buprenorphine STADA 5 mikrogram/timme depotplåster
DE/H/4397/001 52809 STADA ARZNEIMITTEL AG SE
BUPRENORPHINE TEVA 0,4 mg, comprimé sublingual
not available NL35073 TEVA SANTÉ FR
Buprenorphine Teva 0,4 mg, sublinguala resoribletter
PT/H/0447/003 46416 TEVA SWEDEN AB SE
Buprenorphine Teva 10 mikrogram/timme depotplåster
DE/H/4491/002 53186 TEVA SWEDEN AB SE
BUPRENORPHINE TEVA 2 mg, comprimé sublingual
not available NL35075 TEVA SANTÉ FR
Buprenorphine Teva 2 mg, sublinguala resoribletter
PT/H/0447/001 44730 TEVA SWEDEN AB SE
Buprenorphine Teva 20 mikrogram/timme depotplåster
DE/H/4491/003 53187 TEVA SWEDEN AB SE
Buprenorphine Teva 35 microgram/u, pleister voor transdermaal gebruik
DE/H/5078/001 BE485964 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva 35 microgrammes/h dispositif transdermique
DE/H/5078/001 BE485964 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva 35 Mikrogramm/s Transdermales Pflaster
DE/H/5078/001 BE485964 TEVA PHARMA BELGIUM N.V./S.A
BE
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine Teva 5 mikrogram/timme depotplåster
DE/H/4491/001 53185 TEVA SWEDEN AB SE
Buprenorphine Teva 52,5 microgram/u, pleister voor transdermaal gebruik
DE/H/5078/002 BE485973 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva 52,5 microgrammes/h dispositif transdermique
DE/H/5078/002 BE485973 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva 52,5 Mikrogramm/s Transdermales Pflaster
DE/H/5078/002 BE485973 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva 70 microgram/u, pleister voor transdermaal gebruik
DE/H/5078/003 BE485982 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva 70 microgrammes/h dispositif transdermique
DE/H/5078/003 BE485982 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva 70 Mikrogramm/s Transdermales Pflaster
DE/H/5078/003 BE485982 TEVA PHARMA BELGIUM N.V./S.A
BE
BUPRENORPHINE TEVA 8 mg, comprimé sublingual
not available NL35078 TEVA SANTÉ FR
Buprenorphine Teva 8 mg, sublinguala resoribletter
PT/H/0447/002 44731 TEVA SWEDEN AB SE
Buprenorphine Teva Hebdomadaire 20 microgrammes/h dispositif transdermique
DE/H/4491/003 BE503244 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva Wekelijks 20 microgram/u pleister voor transdermaal gebruik
DE/H/4491/003 BE503244 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva Wekelijks 5 microgram/u pleister voor transdermaal gebruik
DE-H-4491-001-003 BE503226 TEVA PHARMA BELGIUM N.V./S.A
BE
List of nationally authorised medicinal products EMA/227734/2018 Page 59/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphine Teva Wöchentlich 10 Mikrogramm/St Transdermales Pflaster
DE/H/4491/002 BE503235 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva Wöchentlich 10 Mikrogramm/St Transdermales Pflaster
DE/H/4491/002 BE503235 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva Wöchentlich 10 Mikrogramm/St Transdermales Pflaster
DE/H/4491/002 BE503235 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva Wöchentlich 20 Mikrogramm/St Transdermales Pflaster
DE/H/4491/003 BE503244 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva Wöchentlich 5 Mikrogramm/St Transdermales Pflaster
DE-H-4491-001-003 BE503226 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine Teva Wöchentlich 5 Mikrogramm/St Transdermales Pflaster
DE/H/4491/001 BE503226 TEVA PHARMA BELGIUM N.V./S.A
BE
Buprenorphine/Sandoz 35 μικρογραμμάρια/ώρα, διαδερμικό επίθεμα
DE/H/4515/001 96237/22-12-2016 SANDOZ PHARMACEUTICALS D.D.
GR
Buprenorphine/Sandoz 52,5 μικρογραμμάρια/ώρα, διαδερμικό επίθεμα
DE/H/4515/002 96238/22-12-2016 SANDOZ PHARMACEUTICALS D.D.
GR
Buprenorphine/Sandoz 70 μικρογραμμάρια/ώρα, διαδερμικό επίθεμα
DE/H/4515/003 96239/22-12-2016 SANDOZ PHARMACEUTICALS D.D.
GR
Buprenorphin-HEXAL sublingual 0,2 mg Sublingualtabletten
UK/H/1944/001 79878.00.00 HEXAL AG DE
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin-HEXAL sublingual 0,4 mg Sublingualtabletten
UK/H/1944/002 79879.00.00 HEXAL AG DE
Buprenorphin-neuraxphann 7 Tage 10 Mikrogramm/Stunde transdermales Pilaster
DE/H/4621/002 96325.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxphann 7 Tage 20 Mikrogramm/Stunde transdermales Pilaster
DE/H/4621/003 96326.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxpharm 0,4 mg Sublingualtabletten
DE/H/4029/001 84374.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxpharm 2 mg Sublingualtabletten
DE/H/4029/002 84376.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxpharm 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4266/001 93893.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxpharm 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4266/002 93894.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxpharm 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4621/001 96324.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxpharm 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4266/003 93895.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-neuraxpharm 8 mg Sublingualtabletten
DE/H/4029/005 84379.00.00 NEURAXPHARM ARZNEIMITTEL GMBH
DE
Buprenorphin-ratiopharm ® 70 Mikrogramm/h Transdermales Pflaster
DE/H/5078/003 5713433 RATIOPHARM LDA PT
Buprenorphin-ratiopharm® 35 Mikrogramm/h Transdermales Pflaster
not available 88450.00.00 RATIOPHARM GMBH DE
List of nationally authorised medicinal products EMA/227734/2018 Page 61/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buprenorphin-ratiopharm® 52,5 Mikrogramm/h Transdermales Pflaster
not available 88451.00.00 RATIOPHARM GMBH DE
Buprenorphin-ratiopharm® 70 Mikrogramm/h Transdermales Pflaster
not available 88452.00.00 RATIOPHARM GMBH DE
Bupretec 35 Mikrogramm/h-transdermales Pflaster
DE/H/4666/001 137464 G.L. PHARMA GMBH AT
Bupretec 35 Mikrogramm/h-transdermales Pflaster
DE/H/4666/001 137464 G.L. PHARMA GMBH AT
Bupretec 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4666/001 96911.00.00 G.L. PHARMA GMBH DE
Bupretec 35 Mikrogramm/Stunde transdermales Pflaster
DE/H/4666/001 96911.00.00 G.L. PHARMA GMBH DE
Bupretec 35 mikrogramov/h transdermálna náplasť
DE/H/4666/001 65/0133/17-S G.L. PHARMA GMBH SK
Bupretec 35 mikrogramov/h transdermálna náplasť
DE/H/4666/001 65/0133/17-S G.L. PHARMA GMBH SK
Bupretec 35 mikrogramů/h transdermální náplast
DE/H/4666/001 65/503/16-C G.L. PHARMA GMBH CZ
Bupretec 35 mikrogramů/h transdermální náplast
DE/H/4666/001 65/503/16-C G.L. PHARMA GMBH CZ
Bupretec 52,5 Mikrogramm/h-transdermales Pflaster
DE/H/4666/002 137465 G.L. PHARMA GMBH AT
Bupretec 52,5 Mikrogramm/h-transdermales Pflaster
DE/H/4666/002 137465 G.L. PHARMA GMBH AT
Bupretec 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4666/002 96912.00.00 G.L. PHARMA GMBH DE
Bupretec 52,5 Mikrogramm/Stunde transdermales Pflaster
DE/H/4666/002 96912.00.00 G.L. PHARMA GMBH DE
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupretec 52,5 mikrogramov/h transdermálna náplasť
DE/H/4666/002 65/0134/17-S G.L. PHARMA GMBH SK
Bupretec 52,5 mikrogramov/h transdermálna náplasť
DE/H/4666/002 65/0134/17-S G.L. PHARMA GMBH SK
Bupretec 52.5 mikrogramu/h transdermální náplast
DE/H/4666/002 65/504/16-C G.L. PHARMA GMBH CZ
Bupretec 52.5 mikrogramu/h transdermální náplast
DE/H/4666/002 65/504/16-C G.L. PHARMA GMBH CZ
Bupretec 70 Mikrogramm/h-transdermales Pflaster
DE/H/4666/003 137466 G.L. PHARMA GMBH AT
Bupretec 70 Mikrogramm/h-transdermales Pflaster
DE/H/4666/003 137466 G.L. PHARMA GMBH AT
Bupretec 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4666/003 96913.00.00 G.L. PHARMA GMBH DE
Bupretec 70 Mikrogramm/Stunde transdermales Pflaster
DE/H/4666/003 96913.00.00 G.L. PHARMA GMBH DE
Bupretec 70 mikrogramov/h transdermálna náplasť
DE/H/4666/003 65/0135/17-S G.L. PHARMA GMBH SK
Bupretec 70 mikrogramov/h transdermálna náplasť
DE/H/4666/003 65/0135/17-S G.L. PHARMA GMBH SK
Bupretec 70 mikrogramů/h transdermální náplast
DE/H/4666/003 65/505/16-C G.L. PHARMA GMBH CZ
Bupretec 70 mikrogramů/h transdermální náplast
DE/H/4666/003 65/505/16-C G.L. PHARMA GMBH CZ
Bupretec, 35 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4666/001 24134 G.L. PHARMA GMBH PL
List of nationally authorised medicinal products EMA/227734/2018 Page 63/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bupretec, 35 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4666/001 24134 G.L. PHARMA GMBH PL
Bupretec, 52,5 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4666/002 24135 G.L. PHARMA GMBH PL
Bupretec, 52,5 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4666/002 24135 G.L. PHARMA GMBH PL
Bupretec, 70 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4666/003 24136 G.L. PHARMA GMBH PL
Bupretec, 70 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4666/003 24136 G.L. PHARMA GMBH PL
Buprex 0,2 mg comprimidos sublinguales
not available 56.858 INDIVIOR UK LIMITED ES
Buprex 0,3 mg solución inyectable
not available 56.403 INDIVIOR UK LIMITED ES
Busette 10 microgrammi/ora cerotto transdermico
DE/H/4046/002 043426081 SANDOZ S.P.A. IT
Busette 10 microgrammi/ora cerotto transdermico
DE/H/4046/002 043426093 SANDOZ S.P.A. IT
Busette 10 microgrammi/ora cerotto transdermico
DE/H/4046/002 043426105 SANDOZ S.P.A. IT
Busette 10 microgrammi/ora cerotto transdermico
DE/H/4046/002 043426117 SANDOZ S.P.A. IT
Busette 10 microgrammi/ora cerotto transdermico
DE/H/4046/002 043426129 SANDOZ S.P.A. IT
Busette 10 microgrammi/ora cerotto transdermico
DE/H/4046/002 043426131 SANDOZ S.P.A. IT
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Busette 10 microgrammi/ora cerotto transdermico
DE/H/4046/002 043426143 SANDOZ S.P.A. IT
Busette 15 microgrammi/ora cerotto transdermico
DE/H/4046/003 043426156 SANDOZ S.P.A. IT
Busette 15 microgrammi/ora cerotto transdermico
DE/H/4046/003 043426168 SANDOZ S.P.A. IT
Busette 15 microgrammi/ora cerotto transdermico
DE/H/4046/003 043426170 SANDOZ S.P.A. IT
Busette 15 microgrammi/ora cerotto transdermico
DE/H/4046/003 043426182 SANDOZ S.P.A. IT
Busette 15 microgrammi/ora cerotto transdermico
DE/H/4046/003 043426194 SANDOZ S.P.A. IT
Busette 15 microgrammi/ora cerotto transdermico
DE/H/4046/003 043426206 SANDOZ S.P.A. IT
Busette 15 microgrammi/ora cerotto transdermico
DE/H/4046/003 043426218 SANDOZ S.P.A. IT
Busette 20 microgrammi/ora cerotto transdermico
DE/H/4046/004 043426220 SANDOZ S.P.A. IT
Busette 20 microgrammi/ora cerotto transdermico
DE/H/4046/004 043426232 SANDOZ S.P.A. IT
Busette 20 microgrammi/ora cerotto transdermico
DE/H/4046/004 043426244 SANDOZ S.P.A. IT
Busette 20 microgrammi/ora cerotto transdermico
DE/H/4046/004 043426257 SANDOZ S.P.A. IT
Busette 20 microgrammi/ora cerotto transdermico
DE/H/4046/004 043426269 SANDOZ S.P.A. IT
Busette 20 microgrammi/ora cerotto transdermico
DE/H/4046/004 043426271 SANDOZ S.P.A. IT
Busette 20 microgrammi/ora cerotto transdermico
DE/H/4046/004 043426283 SANDOZ S.P.A. IT
Busette 5 microgrammi/ora cerotto transdermico
DE/H/4046/001 043426016 SANDOZ S.P.A. IT
Busette 5 microgrammi/ora cerotto transdermico
DE/H/4046/001 043426028 SANDOZ S.P.A. IT
Busette 5 microgrammi/ora cerotto transdermico
DE/H/4046/001 043426030 SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/227734/2018 Page 65/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Busette 5 microgrammi/ora cerotto transdermico
DE/H/4046/001 043426042 SANDOZ S.P.A. IT
Busette 5 microgrammi/ora cerotto transdermico
DE/H/4046/001 043426055 SANDOZ S.P.A. IT
Busette 5 microgrammi/ora cerotto transdermico
DE/H/4046/001 043426067 SANDOZ S.P.A. IT
Busette 5 microgrammi/ora cerotto transdermico
DE/H/4046/001 043426079 SANDOZ S.P.A. IT
Busiete 10 micrograms/hour Transdermal Patch
DE/H/4491/002 PA1986/026/002 TEVA B.V IE
Busiete 10 micrograms/hour Transdermal Patch
DE/H/4491/002 MA1060/01902 TEVA B.V MT
Busiete 10 micrograms/hour Transdermal Patch
DE/H/4491/002 PL 00289/2023 TEVA UK LIMITED UK
Busiete 20 micrograms/hour Transdermal Patch
DE/H/4491/001 PA1986/026/003 TEVA B.V IE
Busiete 20 micrograms/hour Transdermal Patch
DE/H/4491/003 MA1060/01903 TEVA B.V MT
Busiete 20 micrograms/hour Transdermal Patch
DE/H/4491/003 PL 00289/2024 TEVA UK LIMITED UK
Busiete 5 micrograms/hour Transdermal Patch
DE/H/4491/001 PA1986/026/001 TEVA B.V IE
Busiete 5 micrograms/hour Transdermal Patch
DE/H/4491/001 MA1060/01901 TEVA B.V MT
Busiete 5 micrograms/hour Transdermal Patch
DE/H/4491/001 PL 00289/2022 TEVA UK LIMITED UK
Butec 10 microgram/hour transdermal patch
not available PL 40431/0025 QDEM PHARMACEUTICALS LIMITED
UK
Butec 15 microgram/hour transdermal patch
not available PL 40431/0027 QDEM PHARMACEUTICALS LIMITED
UK
Butec 20 microgram/hour transdermal patch
not available PL 40431/0026 QDEM PHARMACEUTICALS LIMITED
UK
Butec 5 microgram/hour transdermal patch
not available PL 40431/0024 QDEM PHARMACEUTICALS LIMITED
UK
BuTrans 10 microgram/uur, pleister voor transdermaal gebruik
DK/H/0718/002 RVG 100978 MUNDIPHARMA PHARMACEUTICALS BV
NL
List of nationally authorised medicinal products EMA/227734/2018 Page 66/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BuTrans 10 micrograms/hour, transdermal patch
DK/H/0718/002 PA 1688/002/002 MUNDIPHARMA PHARMACEUTICALS LIMITED
IE
BuTrans 10 μg/h transdermal patch
DK/H/0718/002 PL 16950/0137 NAPP PHARMACEUTICALS LTD
UK
BuTrans 15 microgram/hour transdermal patch
DK/H/0718/004 PA 1688/2/4 MUNDIPHARMA PHARMACEUTICALS LIMITED
IE
BuTrans 15 microgram/hour transdermal patch
DK/H/0718/004 PL 16950/0349 NAPP PHARMACEUTICALS LTD
UK
BuTrans 20 microgram/uur, pleister voor transdermaal gebruik
DK/H/0718/003 RVG 100979 MUNDIPHARMA PHARMACEUTICALS BV
NL
BuTrans 20 micrograms/hour, transdermal patch
DK/H/0718/003 PA 1688/002/003 MUNDIPHARMA PHARMACEUTICALS LIMITED
IE
BuTrans 20 μg/h transdermal patch
DK/H/0718/003 PL 16950/0138 NAPP PHARMACEUTICALS LTD
UK
BuTrans 5 microgram/uur, pleister voor transdermaal gebruik
DK/H/0718/001 RVG 100975 MUNDIPHARMA PHARMACEUTICALS BV
NL
BuTrans 5 micrograms/hour, transdermal patch
DK/H/0718/001 PA 1688/002/001 MUNDIPHARMA PHARMACEUTICALS LIMITED
IE
BuTrans 5 μg/h, transdermal patch
DK/H/0718/001 PL 16950/0136 NAPP PHARMACEUTICALS LTD
UK
BuTrans, depotplastre DK/H/1986/003 47513 NORPHARMA A/S DK BuTrans, depotplastre DK/H/1986/002 47512 NORPHARMA A/S DK BuTrans, depotplastre DK/H/1986/001 47511 NORPHARMA A/S DK Buvera 35 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1738/001 73821.00.00 LUYE PHARMA AG DE
BUVERA 35 μικρογραμμάρια/ώρα, διαδερμικά έμπλαστρα
DE/H/4229/003/DC 022607 RAFARM SA. CY
BUVERA 35 μικρογραμμάρια/ώρα, διαδερμικά έμπλαστρα
DE/H/4229/01-03 36480/27-04-2016 RAFARM SA. GR
List of nationally authorised medicinal products EMA/227734/2018 Page 67/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Buvera 52,5 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1738/002 73822.00.00 LUYE PHARMA AG DE
BUVERA 52,5 μικρογραμμάρια/ώρα, διαδερμικά έμπλαστρα
DE/H/4229/003/DC 022608 RAFARM SA. CY
BUVERA 52,5 μικρογραμμάρια/ώρα, διαδερμικά έμπλαστρα
DE/H/4229/01-03 36481/27-04-2016 RAFARM SA. GR
Buvera 70 Mikrogramm/Stunde Transdermales Pflaster
DE/H/1738/003 73823.00.00 LUYE PHARMA AG DE
BUVERA 70 μικρογραμμάρια/ώρα, διαδερμικά έμπλαστρα
DE/H/4229/003/DC 022609 RAFARM SA. CY
BUVERA 70 μικρογραμμάρια/ώρα, διαδερμικά έμπλαστρα
DE/H/4229/01-03 36482/27-04-2016 RAFARM SA. GR
Carlosafine 10 mikrogram/time depotplaster
DE/H/4394/002 15-10649 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NO
Carlosafine 20 mikrogram/time depotplaster
DE/H/4394/003 15-10650 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NO
Carlosafine 35 micrograms/h transdermal patch
DE/H/5080/001 PL 25258/0171 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Carlosafine 5 mikrogram/time depotplaster
DE/H/4394/001 15-10648 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NO
Carlosafine 52.5 micrograms/h transdermal patch
DE/H/5080/002 PL 25258/0172 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
Carlosafine 70 micrograms/h transdermal patch
DE/H/5080/003 PL 25258/0173 GLENMARK PHARMACEUTICALS EUROPE LIMITED
UK
List of nationally authorised medicinal products EMA/227734/2018 Page 68/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Dolotec 7-Tagepflaster 10 Mikrogramm/Stunde transdermales Pflaster
DK/H/1986/002 96144.00.00 MUNDIPHARMA GMBH DE
Dolotec 7-Tagepflaster 20 Mikrogramm/Stunde transdermales Pflaster
DK/H/1986/003 96145.00.00 MUNDIPHARMA GMBH DE
Dolotec 7-Tagepflaster 5 Mikrogramm/Stunde transdermales Pflaster
DK/H/1986/001 96143.00.00 MUNDIPHARMA GMBH DE
Durlevatec 35 microgrammi/ora, cerotto transdermico
DE/H/4514/001 044388039 SANDOZ S.P.A. IT
Durlevatec 35 microgrammi/ora, cerotto transdermico
DE/H/4514/001 044388041 SANDOZ S.P.A. IT
Durlevatec 35 microgrammi/ora, cerotto transdermico
DE/H/4514/001 044388054 SANDOZ S.P.A. IT
Durlevatec 35 microgrammi/ora, cerotto transdermico
DE/H/4514/001 044388066 SANDOZ S.P.A. IT
Durlevatec 35 microgrammi/ora, cerotto transdermico
DE/H/4514/001 044388078 SANDOZ S.P.A. IT
Durlevatec 35 microgrammi/ora, cerotto transdermico
DE/H/4514/001 044388027 SANDOZ S.P.A. IT
Durlevatec 35 microgrammi/ora, cerotto transdermico
DE/H/4514/001 044388015 SANDOZ S.P.A. IT
Durlevatec 52,5 microgrammi/ora, cerotto transdermico
DE/H/4514/002 044388080 SANDOZ S.P.A. IT
Durlevatec 52,5 microgrammi/ora, cerotto transdermico
DE/H/4514/002 044388092 SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/227734/2018 Page 69/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Durlevatec 52,5 microgrammi/ora, cerotto transdermico
DE/H/4514/002 044388116 SANDOZ S.P.A. IT
Durlevatec 52,5 microgrammi/ora, cerotto transdermico
DE/H/4514/002 044388128 SANDOZ S.P.A. IT
Durlevatec 52,5 microgrammi/ora, cerotto transdermico
DE/H/4514/002 044388130 SANDOZ S.P.A. IT
Durlevatec 52,5 microgrammi/ora, cerotto transdermico
DE/H/4514/002 044388142 SANDOZ S.P.A. IT
Durlevatec 52,5 microgrammi/ora, cerotto transdermico
DE/H/4514/002 044388104 SANDOZ S.P.A. IT
Durlevatec 70 microgrammi/ora, cerotto transdermico
DE/H/4514/003 044388167 SANDOZ S.P.A. IT
Durlevatec 70 microgrammi/ora, cerotto transdermico
DE/H/4514/003 044388179 SANDOZ S.P.A. IT
Durlevatec 70 microgrammi/ora, cerotto transdermico
DE/H/4514/003 044388193 SANDOZ S.P.A. IT
Durlevatec 70 microgrammi/ora, cerotto transdermico
DE/H/4514/003 044388205 SANDOZ S.P.A. IT
Durlevatec 70 microgrammi/ora, cerotto transdermico
DE/H/4514/003 044388217 SANDOZ S.P.A. IT
Durlevatec 70 microgrammi/ora, cerotto transdermico
DE/H/4514/003 044388181 SANDOZ S.P.A. IT
Durlevatec 70 microgrammi/ora, cerotto transdermico
DE/H/4514/003 044388155 SANDOZ S.P.A. IT
Feliben 35 microgramos/h parches transdérmicos
DE/H/1044/001 70.804 LABORATORIOS GEBRO PHARMA, S.A.
ES
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Feliben 52,5 microgramos/h parches transdérmicos
DE/H/1044/002 70.805 LABORATORIOS GEBRO PHARMA, S.A.
ES
Feliben 70 microgramos/h parches transdérmicos
DE/H/1044/003 70.806 LABORATORIOS GEBRO PHARMA, S.A.
ES
Hapoctasin 35 microgram/h, transdermal patches
DE/H/1044/001 PL 30306/0426 ACTAVIS GROUP PTC EHF. UK
Hapoctasin 52.5 microgram/h, transdermal patches
DE/H/1044/002 PL 30306/0428 ACTAVIS GROUP PTC EHF. UK
Hapoctasin 70 microgram/h, transdermal patches
DE/H/1044/003 PL 30306/0429 ACTAVIS GROUP PTC EHF. UK
Laribon 35 mikrograma/h transdermalni flaster
DE/H/5078/001 HR-H-870370219 PLIVA HRVATSKA D.O.O. HR
Melodyn, 35 mikrogramów/godzinę, system transdermalny
DE/H/1738/001 17383 G.L. PHARMA GMBH PL
Melodyn, 52,5 mikrogramów/godzinę, system transdermalny
DE/H/1738/002 17384 G.L. PHARMA GMBH PL
Melodyn, 70 mikrogramów/godzinę, system transdermalny
DE/H/1738/003 17385 G.L. PHARMA GMBH PL
Mitoren 10 mikrograma/h transdermalni flaster
DE/H/4491/002 HR-H-826180306 PLIVA HRVATSKA D.O.O. HR
Mitoren 20 mikrograma/h transdermalni flaster
DE/H/4491/003 HR-H-862548577 PLIVA HRVATSKA D.O.O. HR
Mitoren 5 mikrograma/h transdermalni flaster
DE/H/4491/001 HR-H-843518107 PLIVA HRVATSKA D.O.O. HR
Molterfin 2 mg sublingual tablets
SE/H/0928/002 42325 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
SE
Molterfin 8 mg sublingual tablets
SE/H/0928/003 42326 L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A.
SE
Natzon 0.4 mg Sublingual Tablets
not available PL 20117/0209 MORNINGSIDE HEALTHCARE LTD
UK
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Natzon 2 mg Sublingual Tablets
UK/H/1827/002 PL 20117/0119 MORNINGSIDE HEALTHCARE LTD
UK
Natzon 8 mg Sublingual Tablets
UK/H/1827/003 PL 20117/0120 MORNINGSIDE HEALTHCARE LTD
UK
Nimedol 0,4 mg sublingvalne tablete
PT/H/1288/001 HR-H-221990733 PLIVA HRVATSKA D.O.O. HR
Nimedol 2 mg sublingvalne tablete
PT/H/1288/002 HR-H-056604005 PLIVA HRVATSKA D.O.O. HR
Nimedol 8 mg sublingvalne tablete
PT/H/1288/003 HR-H-481991441 PLIVA HRVATSKA D.O.O. HR
Noprex 35 mikrogramov/h transdermálna náplasť
DE/H/5080/001 65/0161/16-S GLENMARK PHARMACEUTICALS S.R.O.
SK
Noprex 35 mikrogramů/h transdermální náplast
DE/H/5080/001 65/280/16-C GLENMARK PHARMACEUTICALS S.R.O.
CZ
Noprex 52,5 mikrogramů/h transdermální náplast
DE/H/5080/002 65/281/16-C GLENMARK PHARMACEUTICALS S.R.O.
CZ
Noprex 52.5 mikrogramov/h transdermálna náplasť
DE/H/5080/002 65/0162/16-S GLENMARK PHARMACEUTICALS S.R.O.
SK
Noprex 70 mikrogramov/h transdermálna náplasť
DE/H/5080/003 65/0163/16-S GLENMARK PHARMACEUTICALS S.R.O.
SK
Noprex 70 mikrogramů/h transdermální náplast
DE/H/5080/003 65/282/16-C GLENMARK PHARMACEUTICALS S.R.O.
CZ
Norfinox, 52,5 mikrograma/godzinę, system transdermalny, plaster
DE/H/4515/002 23434 SANDOZ GMBH PL
Norfinox, 70 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4515/003 23435 SANDOZ GMBH PL
Norfinox,35 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4515/001 23433 SANDOZ GMBH PL
Norspan 40 mikrog/t depotlaastari
DK/H/0718/007 31551 MUNDIPHARMA OY FI
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Norspan 10 mikrog/t depotlaastari
DK/H/0718/002 24051 MUNDIPHARMA OY FI
Norspan 10 mikrog/time depotplaster
DK/H/0718/002 04-3091 MUNDIPHARMA AS. NO
Norspan 10 mikrogram/timme depotplåster
DK/H/0718/002 21883 MUNDIPHARMA AB SE
Norspan 10 mikrogrami/stunda transdermals plaksteris
DK/H/0718/002 08-0177 MUNDIPHARMA GES.M.B.H LV
Norspan 10 mikrogramm/h transzdermális tapasz
DK/H/0718/002 OGYI-T-20514/04 MUNDIPHARMA GES.M.B.H HU
Norspan 10 mikrogramm/h transzdermális tapasz
DK/H/0718/002 OGYI-T-20514/03 MUNDIPHARMA GES.M.B.H HU
Norspan 10 mikrogramm/h transzdermális tapasz
DK/H/0718/002 OGYI-T-20514/04 MUNDIPHARMA GES.M.B.H HU
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/012 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/009 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/015 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/014 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/010 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/016 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/013 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Norspan 10 mikrogramų per valandą transderminis pleistras
DK/H/0718/002 LT/1/08/1184/011 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 15 mikrog/t depotlaastari
DK/H/0718/004 31548 MUNDIPHARMA OY FI
Norspan 15 mikrogram/timme depotplåster
DK/H/0718/004 49408 MUNDIPHARMA AB SE
Norspan 20 mikrog/t depotlaastari
DK/H/0718/003 24052 MUNDIPHARMA OY FI
Norspan 20 mikrog/time depotplaster
DK/H/0718/003 04-3092 MUNDIPHARMA AS. NO
Norspan 20 mikrogram/timme depotplåster
DK/H/0718/003 21884 MUNDIPHARMA AB SE
Norspan 20 mikrogrami/stunda transdermals plaksteris
DK/H/0718/003 08-0178 MUNDIPHARMA GES.M.B.H LV
Norspan 20 mikrogramm/h transzdermális tapasz
DK/H/0718/003 OGYI-T-20514/06 MUNDIPHARMA GES.M.B.H HU
Norspan 20 mikrogramm/h transzdermális tapasz
DK/H/0718/003 OGYI-T-20514/05 MUNDIPHARMA GES.M.B.H HU
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/019 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/018 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/020 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/021 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/024 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/023 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/022 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 20 mikrogramų per valandą transderminis pleistras
DK/H/0718/003 LT/1/08/1184/017 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 25 mikrog/t depotlaastari
DK/H/0718/005 31549 MUNDIPHARMA OY FI
Norspan 25 mikrog/time depotplaster
DK/H/0718/005 13-9542 MUNDIPHARMA AS. NO
Norspan 25 mikrogram/timme depotplåster
DK/H/0718/005 49409 MUNDIPHARMA AB SE
Norspan 30 mikrog/t depotlaastari
DK/H/0718/006 31550 MUNDIPHARMA OY FI
Norspan 30 mikrog/time depotplaster
DK/H/0718/006 13-9543 MUNDIPHARMA AS. NO
Norspan 30 mikrogram/timme depotplåster
DK/H/0718/006 49410 MUNDIPHARMA AB SE
Norspan 30 Mikrogramm/h transdermales Pflaster
DK/H/0718/006 90197.00.00 MUNDIPHARMA GMBH DE
Norspan 40 mikrog/time depotplaster
DK/H/0718/004 13-9541 MUNDIPHARMA AS. NO
Norspan 40 mikrog/time depotplaster
DK/H/0718/007 13-9544 MUNDIPHARMA AS. NO
Norspan 40 mikrogram/timme depotplåster
DK/H/0718/007 49411 MUNDIPHARMA AB SE
Norspan 40 Mikrogramm/h transdermales Pflaster
DK/H/0718/007 90198.00.00 MUNDIPHARMA GMBH DE
Norspan 5 mikrog/t depotlaastari
DK/H/0718/001 24050 MUNDIPHARMA OY FI
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Norspan 5 mikrog/time depotplaster
DK/H/0718/001 04-3090 MUNDIPHARMA AS. NO
Norspan 5 mikrogram/timme depotplåster
DK/H/0718/001 21882 MUNDIPHARMA AB SE
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/006 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/002 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/004 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/008 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/001 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/005 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/003 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogramai per valandą transderminis pleistras
DK/H/0718/001 LT/1/08/1184/007 MUNDIPHARMA GESELLSCHAFT M.B.H.
LT
Norspan 5 mikrogrami/stunda transdermals plaksteris
DK/H/0718/001 08-0176 MUNDIPHARMA GES.M.B.H LV
Norspan 5 mikrogramm/h transzdermális tapasz
DK/H/0718/001 OGYI-T-20514/02 MUNDIPHARMA GES.M.B.H HU
Norspan 5 mikrogramm/h transzdermális tapasz
DK/H/0718/001 OGYI-T-20514/01 MUNDIPHARMA GES.M.B.H HU
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Norspan forðaplástur 10 míkróg/klst
DK/H/0718/002 IS/1/05/032/02 NORPHARMA A/S IS
Norspan forðaplástur 15 míkrógrömm/klst
DK/H/0718/004 IS/1/14/049/01 NORPHARMA A/S IS
Norspan forðaplástur 20 míkróg/klst
DK/H/0718/003 IS/1/05/032/03 NORPHARMA A/S IS
Norspan forðaplástur 25 míkrógrömm/klst
DK/H/0718/005 IS/1/14/049/02 NORPHARMA A/S IS
Norspan forðaplástur 30 míkrógrömm/klst
DK/H/0718/006 IS/1/14/049/03 NORPHARMA A/S IS
Norspan forðaplástur 40 míkrógrömm/klst
DK/H/0718/007 IS/1/14/049/04 NORPHARMA A/S IS
Norspan forðaplástur 5 míkróg/klst
DK/H/0718/001 IS/1/05/032/01 NORPHARMA A/S IS
Norspan, 10 µg/godz., system transdermalny, plaster
DK/H/0718/002 18437 NORPHARMA A/S PL
Norspan, 10 mikrogrammi/tunnis transdermaalne plaaster
DK/H/0718/002 578908 MUNDIPHARMA GES.M.B.H EE
Norspan, 20 µg/godz., system transdermalny, plaster
DK/H/0718/003 18438 NORPHARMA A/S PL
Norspan, 20 mikrogrammi/tunnis transdermaalne plaaster
DK/H/0718/003 578808 MUNDIPHARMA GES.M.B.H EE
Norspan, 5 µg/godz., system transdermalny, plaster
DK/H/0718/001 18436 NORPHARMA A/S PL
Norspan, 5 mikrogrammi/tunnis transdermaalne plaaster
DK/H/0718/001 579008 MUNDIPHARMA GES.M.B.H EE
Norspan, depotplastre 10 mikrogram/time
DK/H/0718/002 33283 NORPHARMA A/S DK
Norspan, depotplastre 15 mikrogram/time
DK/H/0718/004 52456 NORPHARMA A/S DK
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Norspan, depotplastre 20 mikrogram/time
DK/H/0718/003 33284 NORPHARMA A/S DK
Norspan, depotplastre 25 mikrogram/time
DK/H/0718/005 52457 NORPHARMA A/S DK
Norspan, depotplastre 30 mikrogram/time
DK/H/0718/006 52458 NORPHARMA A/S DK
Norspan, depotplastre 40 mikrogram/time
DK/H/0718/007 52459 NORPHARMA A/S DK
Norspan, depotplastre 5 mikrogram/time
DK/H/0718/001 33282 NORPHARMA A/S DK
Norspan® 20 Mikrogramm/Stunde transdermales Pflaster
DK/H/0718/003 1-26642 MUNDIPHARMA GES.M.B.H AT
Norspan® 10 Mikrogramm/h transdermales Pflaster
DK/H/0718/002 62139.00.00 MUNDIPHARMA GMBH DE
Norspan® 20 Mikrogramm/h transdermales Pflaster
DK/H/0718/003 62140.00.00 MUNDIPHARMA GMBH DE
Norspan® 5 Mikrogramm/h transdermales Pflaster
DK/H/0718/001 62138.00.00 MUNDIPHARMA GMBH DE
Norspan® 5 Mikrogramm/Stunde transdermales Pflaster
DK/H/0718/001 1-26640 MUNDIPHARMA GES.M.B.H AT
Norspan® 5 Mikrogramm/Stunde transdermales Pflaster
DK/H/0718/002 1-26641 MUNDIPHARMA GES.M.B.H AT
Norvipren UK/H/1943/001 46124 SANDOZ A/S DK Norvipren UK/H/1943/002 46125 SANDOZ A/S DK Norvipren, 52,5 mikrograma/godzinę, system transdermalny, plaster
DE/H/4451/002 23221 SANDOZ GMBH PL
Norvipren, 70 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4451/003 23222 SANDOZ GMBH PL
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Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Norvipren,35 mikrogramów/godzinę, system transdermalny, plaster
DE/H/4451/001 23220 SANDOZ GMBH PL
Panitaz 10 micrograms/h Transdermal Patches
not available PL 08553/0565 DR. REDDY'S LABORATORIES (UK) LTD.
UK
Panitaz 20 micrograms/h Transdermal Patches
not available PL 08553/0566 DR. REDDY'S LABORATORIES (UK) LTD.
UK
Panitaz 5 micrograms/h Transdermal Patches
not available PL 08553/0564 DR. REDDY'S LABORATORIES (UK) LTD.
UK
Prefibin 0.4 mg sublingual tablets
UK/H/1940/003 PL 04416/0950 SANDOZ LTD UK
Prefibin 2 mg sublingual tablets
UK/H/1940/001 PL 04416/0948 SANDOZ LTD UK
Prefibin 8 mg sublingual tablets
UK/H/1940/002 PL 04416/0949 SANDOZ LTD UK
PRENORVINE 2 mg υπογλώσσια δισκία
not available 20882/21-12-2011 RAFARM SA. GR
PRENORVINE 8 mg, υπογλώσσια δισκία
not available 83738/21-12-2011 RAFARM SA. GR
Prenotrix 35 micrograms/h, transdermal patches
DE/H/1737/001 PL 28444/0130 ACTIVASE PHARMACEUTICALS LIMITED
UK
Prenotrix 52.5 micrograms/h, transdermal patch
DE/H/1737/002 PL 28444/0131 ACTIVASE PHARMACEUTICALS LIMITED
UK
Prenotrix 70 micrograms/h, transdermal patch
DE/H/1737/003 PL 28444/0132 ACTIVASE PHARMACEUTICALS LIMITED
UK
Ramatrix 35 microgramas/h sistema transdérmico
not available 5581525 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Ramatrix 35 microgramas/h sistema transdérmico
not available 5581533 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Ramatrix 52,5 microgramas/h, sistema transdérmico
not available 5581558 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Ramatrix 52,5 microgramas/h, sistema transdérmico
not available 5581541 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
List of nationally authorised medicinal products EMA/227734/2018 Page 79/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Ramatrix 70 microgramas/h, sistema transdérmico
not available 5583026 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Ramatrix 70 microgramas/h, sistema transdérmico
not available 5583018 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Ravata 2 mg sublingvální tablety
not available 19/489/16-C HEATON K.S. CZ
Ravata 8 mg sublingvální tablety
not available 19/490/16-C HEATON K.S. CZ
Reletrans 10 microgram/hour transdermal patch
DE/H/4045/002 PL 04416/1407 SANDOZ LTD UK
Reletrans 10 micrograms/hour Transdermal Patches
DE/H/4045/002 PA0711/236/002 ROWEX LTD IE
Reletrans 15 microgram/hour transdermal patch
DE/H/4045/003 PL 04416/1408 SANDOZ LTD UK
Reletrans 15 micrograms/hour Transdermal Patch
DE/H/4045/003 PA0711/236/003 ROWEX LTD IE
Reletrans 20 microgram/hour transdermal patch
DE/H/4045/004 PL 04416/1409 SANDOZ LTD UK
Reletrans 20 micrograms/hour Transdermal Patch
DE/H/4045/004 PA0711/236/004 ROWEX LTD IE
Reletrans 5 microgram/hour transdermal patch
DE/H/4045/001 PL 04416/1406 SANDOZ LTD UK
Reletrans 5 micrograms/hour Transdermal Patches
DE/H/4045/001 PA0711/236/001 ROWEX LTD IE
Relevtec 35 microgram/hour transdermal patch
DE/H/4515/001 PL 04416/1455 SANDOZ LTD UK
Relevtec 52.5 microgram/hour transdermal patch
DE/H/4515/002 PL 04416/1456 SANDOZ LTD UK
List of nationally authorised medicinal products EMA/227734/2018 Page 80/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Relevtec 70 microgram/hour transdermal patch
DE/H/4515/003 PL 04416/1457 SANDOZ LTD UK
Sevodyne 10 microgram/hour transdermal patch
UK/H/6527/002 PL 35533/0060 ASPIRE PHARMA LIMITED UK
Sevodyne 20 microgram/hour transdermal patch
UK/H/6527/003 PL 35533/0061 ASPIRE PHARMA LIMITED UK
Sevodyne 5 microgram/hour transdermal patch
UK/H/6527/001 PL 35533/0059 ASPIRE PHARMA LIMITED UK
SUBUTEX 2 mg Sublingualtabletten
FR/H/0147/002 0703-98-07-045 INDIVIOR UK LIMITED LU
SUBUTEX 0,4 mg – Sublingualtabletten
not available 1-23092 INDIVIOR UK LIMITED AT
Subutex 0,4 mg compresse sublinguali
not available 033791017 INDIVIOR UK LIMITED IT
Subutex 0,4 mg comprimidos sublinguais
FR/H/0147/001 3066982 INDIVIOR UK LIMITED PT
Subutex 0,4 mg comprimidos sublinguais
FR/H/0147/001 3067089 INDIVIOR UK LIMITED PT
SUBUTEX 0,4 mg poliežuvinės tabletės
FR/H/0147/001 LT/1/05/0345/001 INDIVIOR UK LIMITED LT
SUBUTEX 0,4 mg poliežuvinės tabletės
FR/H/0147/001 LT/1/05/0345/002 INDIVIOR UK LIMITED LT
Subutex 0,4 mg resoriblett, sublingual
not available 14275 INDIVIOR UK LIMITED SE
SUBUTEX 0,4 mg Sublingualtabletten
FR/H/0147/001 BE 209657 INDIVIOR UK LIMITED BE
SUBUTEX 0,4 mg Sublingualtabletten
FR/H/0147/001 0703-98-07-044 INDIVIOR UK LIMITED LU
Subutex 0,4 mg sublingvalne tablete
not available UP/I-530-09/12-02/366 INDIVIOR UK LIMITED HR
SUBUTEX 0,4 mg tabletten voor sublinguaal gebruik
FR/H/0147/001 BE 209657 INDIVIOR UK LIMITED BE
SUBUTEX 0,4 mg tabletten voor sublinguaal gebruik
FR/H/0147/001 0703-98-07-044 INDIVIOR UK LIMITED LU
List of nationally authorised medicinal products EMA/227734/2018 Page 81/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Subutex 0,4 mg tungurótartöflur
not available 980143 INDIVIOR UK LIMITED IS
Subutex 0,4 mg, comprimé sublingual
FR/H/0147/001 339 444.2 INDIVIOR UK LIMITED FR
Subutex 0,4 mg, comprimé sublingual
FR/H/0147/001 345 660.5 INDIVIOR UK LIMITED FR
SUBUTEX 0,4 mg, comprimés sublinguaux
FR/H/0147/001 BE209657 INDIVIOR UK LIMITED BE
SUBUTEX 0,4 mg, comprimés sublinguaux
FR/H/0147/001 0703-98-07-044 INDIVIOR UK LIMITED LU
Subutex 0,4 mg, sublingvální tablety
FR/H/0147/001 19/137/00-C INDIVIOR UK LIMITED CZ
SUBUTEX 0,4 mg, υπογλώσσια δισκία
FR/H/0147/001 20071 INDIVIOR UK LIMITED CY
Subutex 0.4 mg sublingual tablets
not available PA 1657/1/1 INDIVIOR UK LIMITED IE
SUBUTEX 0.4mg sublingual tablets
not available PL 36699/0001 INDIVIOR UK LIMITED UK
SUBUTEX 2 mg – Sublingualtabletten
not available 1-23091 INDIVIOR UK LIMITED AT
Subutex 2 mg compresse sublinguali
not available 033791029 INDIVIOR UK LIMITED IT
SUBUTEX 2 mg comprimés sublinguaux
FR/H/0147/002 BE209666 INDIVIOR UK LIMITED BE
Subutex 2 mg comprimidos sublinguais
FR/H/0147/002 3067188 INDIVIOR UK LIMITED PT
Subutex 2 mg comprimidos sublinguais
FR/H/0147/002 3067287 INDIVIOR UK LIMITED PT
SUBUTEX 2 mg poliežuvinės tabletės
FR/H/0147/002 LT/1/05/0345/003 INDIVIOR UK LIMITED LT
SUBUTEX 2 mg poliežuvinės tabletės
FR/H/0147/002 LT/1/05/0345/004 INDIVIOR UK LIMITED LT
Subutex 2 mg resoriblett, sublingual
not available 14276 INDIVIOR UK LIMITED SE
SUBUTEX 2 mg resoribletter, sublinguala
not available 13354 INDIVIOR UK LIMITED FI
Subutex 2 mg resoriblettiä not available 13354 INDIVIOR UK LIMITED FI
List of nationally authorised medicinal products EMA/227734/2018 Page 82/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Subutex 2 mg sublingual tablets
not available PA 1657/1/2 INDIVIOR UK LIMITED IE
SUBUTEX 2 mg Sublingualtabletten
FR/H/0147/002 BE 209666 INDIVIOR UK LIMITED BE
Subutex 2 mg sublingvalne tablete
not available UP/I-530-09/12-02/367 INDIVIOR UK LIMITED HR
Subutex 2 mg sublingvaltabletter
not available 98-3821 INDIVIOR UK LIMITED NO
Subutex 2 mg tabletes lietošanai zem mēles
FR/H/0147/002 05-0401 INDIVIOR UK LIMITED LV
SUBUTEX 2 mg tabletten voor sublinguaal gebruik
FR/H/0147/002 BE 209666 INDIVIOR UK LIMITED BE
SUBUTEX 2 mg tabletten voor sublinguaal gebruik
FR/H/0147/002 0703-98-07-045 INDIVIOR UK LIMITED LU
Subutex 2 mg tungurótartöflur
not available 980144 INDIVIOR UK LIMITED IS
Subutex 2 mg, comprimé sublingual
FR/H/0147/002 339 514 0 INDIVIOR UK LIMITED FR
Subutex 2 mg, comprimé sublingual
FR/H/0147/002 345 661 1 INDIVIOR UK LIMITED FR
SUBUTEX 2 mg, comprimés sublinguaux
FR/H/0147/002 0703-98-07-045 INDIVIOR UK LIMITED LU
Subutex 2 mg, sublingvální tablety
FR/H/0147/002 19/138/00-C INDIVIOR UK LIMITED CZ
SUBUTEX 2 mg, υπογλώσσια δισκία
FR/H/0147/002 20072 INDIVIOR UK LIMITED CY
Subutex 2mg pilloli għal taħt l-ilsien
not available MA980/00101 INDIVIOR UK LIMITED MT
SUBUTEX 2mg sublingual tablets
not available PL 36699/0002 INDIVIOR UK LIMITED UK
SUBUTEX 8 mg – Sublingualtabletten
not available 1-23093 INDIVIOR UK LIMITED AT
Subutex 8 mg compresse sublinguali
not available 033791031 INDIVIOR UK LIMITED IT
Subutex 8 mg comprimidos sublinguais
FR/H/0147/003 3067386 INDIVIOR UK LIMITED PT
List of nationally authorised medicinal products EMA/227734/2018 Page 83/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Subutex 8 mg comprimidos sublinguais
FR/H/0147/003 3067485 INDIVIOR UK LIMITED PT
SUBUTEX 8 mg poliežuvinės tabletės
FR/H/0147/003 LT/1/05/0345/005 INDIVIOR UK LIMITED LT
SUBUTEX 8 mg poliežuvinės tabletės
FR/H/0147/003 LT/1/05/0345/006 INDIVIOR UK LIMITED LT
Subutex 8 mg resoriblett, sublingual
not available 14277 INDIVIOR UK LIMITED SE
SUBUTEX 8 mg resoribletter, sublinguala
not available 13355 INDIVIOR UK LIMITED FI
Subutex 8 mg resoriblettiä not available 13355 INDIVIOR UK LIMITED FI Subutex 8 mg sublingual tablets
not available PA 1657/1/3 INDIVIOR UK LIMITED IE
SUBUTEX 8 mg Sublingualtabletten
FR/H/0147/003 0703-98-07-046 INDIVIOR UK LIMITED LU
SUBUTEX 8 mg Sublingualtabletten Buprenorphin-Hydrochlorid
FR/H/0147/003 BE 209675 INDIVIOR UK LIMITED BE
Subutex 8 mg sublingvalne tablete
not available UP/I-530-09/12-02/368 INDIVIOR UK LIMITED HR
Subutex 8 mg sublingvaltabletter
not available 98-3822 INDIVIOR UK LIMITED NO
Subutex 8 mg tabletes lietošanai zem mēles
FR/H/0147/003 05-0402 INDIVIOR UK LIMITED LV
SUBUTEX 8 mg tabletten voor sublinguaal gebruik
FR/H/0147/003 BE 209675 INDIVIOR UK LIMITED BE
SUBUTEX 8 mg tabletten voor sublinguaal gebruik
FR/H/0147/003 0703-98-07-046 INDIVIOR UK LIMITED LU
SUBUTEX 8 mg, comprimé sublingual
FR/H/0147/003 339 439 9 INDIVIOR UK LIMITED FR
SUBUTEX 8 mg, comprimé sublingual
FR/H/0147/003 345 662 8 INDIVIOR UK LIMITED FR
SUBUTEX 8 mg, comprimés sublinguaux
FR/H/0147/003 BE209675 INDIVIOR UK LIMITED BE
SUBUTEX 8 mg, comprimés sublinguaux
FR/H/0147/003 0703-98-07-046 INDIVIOR UK LIMITED LU
List of nationally authorised medicinal products EMA/227734/2018 Page 84/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Subutex 8 mg, sublingvální tablety
FR/H/0147/003 19/139/00-C INDIVIOR UK LIMITED CZ
SUBUTEX 8 mg, υπογλώσσια δισκία
FR/H/0147/003 20073 INDIVIOR UK LIMITED CY
Subutex 8mg pilloli għal taħt l-ilsien
not available MA980/00102 INDIVIOR UK LIMITED MT
SUBUTEX 8mg sublingual tablets
not available PL 36699/0003 INDIVIOR UK LIMITED UK
Subutex 8mg tungurótartöflur
not available 980145 INDIVIOR UK LIMITED IS
Subutex, sublinguale resoribletter
not available 19574 INDIVIOR UK LIMITED DK
Subutex, sublinguale resoribletter
not available 19573 INDIVIOR UK LIMITED DK
Subutex, sublinguale resoribletter
not available 19572 INDIVIOR UK LIMITED DK
SUBUTEX® 0,4 mg not available 42769.00.00 INDIVIOR UK LIMITED DE SUBUTEX® 2 mg not available 42769.01.00 INDIVIOR UK LIMITED DE SUBUTEX® 8 mg not available 42769.02.00 INDIVIOR UK LIMITED DE Temgesic 0, 3 mg/ml oplossing voor injectie
not available RVG 08725 INDIVIOR UK LIMITED NL
TEMGESIC 0,2 mg compresse sublinguali
not available 025215029 INDIVIOR UK LIMITED IT
TEMGESIC 0,2 mg compresse sublinguali
not available 025215043 INDIVIOR UK LIMITED IT
Temgesic 0,2 mg resoriblett not available 8390 INDIVIOR UK LIMITED FI Temgesic 0,2 mg resoriblett, sublingual
not available 10474 INDIVIOR UK LIMITED SE
Temgesic 0,2 mg resoribletti not available 8390 INDIVIOR UK LIMITED FI Temgesic 0,2 mg tabletten voor sublinguaal gebruik
not available RVG 11872 INDIVIOR UK LIMITED NL
TEMGESIC 0,2 mg, comprimé sublingual
not available 329 527-2 OU 34009 329 527 2 4
INDIVIOR UK LIMITED FR
TEMGESIC 0,2 mg, comprimé sublingual
not available 329 528-9 OU 34009 329 528 9 2
INDIVIOR UK LIMITED FR
TEMGESIC 0,2 mg, comprimé sublingual
not available 329 529-5 OU 34009 329 529 5 3
INDIVIOR UK LIMITED FR
List of nationally authorised medicinal products EMA/227734/2018 Page 85/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TEMGESIC 0,2 mg, comprimé sublingual
not available 555 708-4 OU 34009 555 708 4 4
INDIVIOR UK LIMITED FR
TEMGESIC 0,2 mg, comprimé sublingual
not available 395 012-7 OU 34009 395 012 7 7
INDIVIOR UK LIMITED FR
TEMGESIC 0,2 mg, comprimé sublingual
not available 395 013-3 OU 34009 395 013 3 8
INDIVIOR UK LIMITED FR
TEMGESIC 0,2 mg, comprimé sublingual
not available 395 015-6 OU 34009 395 015 6 7
INDIVIOR UK LIMITED FR
TEMGESIC 0,2 mg, comprimé sublingual
not available 575 373-8 OU 34009 575 373 8 8
INDIVIOR UK LIMITED FR
Temgesic 0,2 mg-Sublingualtabletten
not available 17.877 INDIVIOR UK LIMITED AT
Temgesic 0,3 mg/ml injeksjonsvæske, oppløsning
not available 6526 INDIVIOR UK LIMITED NO
Temgesic 0,3 mg/ml injektioneste, liuos
not available 8153 INDIVIOR UK LIMITED FI
Temgesic 0,3 mg/ml injektionsvätska, lösning
not available 8153 INDIVIOR UK LIMITED FI
Temgesic 0,3 mg/ml injektionsvätska, lösning
not available 9719 INDIVIOR UK LIMITED SE
Temgesic 0,3 mg/ml oplossing voor injectie
not available BE 112515 INDIVIOR UK LIMITED BE
Temgesic 0,3 mg/ml oplossing voor injectie
not available 0703/02127475 INDIVIOR UK LIMITED LU
Temgesic 0,3 mg/ml, Injektionslösung
not available BE 112515 INDIVIOR UK LIMITED BE
Temgesic 0,3 mg/ml, Injektionslösung
not available 0703/02127475 INDIVIOR UK LIMITED LU
Temgesic 0,3 mg/ml, solution injectable
not available BE 112515 INDIVIOR UK LIMITED BE
Temgesic 0,3 mg/ml, solution injectable
not available 0703/02127475 INDIVIOR UK LIMITED LU
Temgésic 0,3 mg/ml, solution injectable
not available 327 309.8 INDIVIOR UK LIMITED FR
Temgésic 0,3 mg/ml, solution injectable
not available 327 310.6 INDIVIOR UK LIMITED FR
List of nationally authorised medicinal products EMA/227734/2018 Page 86/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Temgésic 0,3 mg/ml, solution injectable
not available 554 874.8 INDIVIOR UK LIMITED FR
Temgésic 0,3 mg/ml, solution injectable
not available 327 308.1 INDIVIOR UK LIMITED FR
TEMGESIC 0,3mg/ml soluzione iniettabile
not available 025215017 INDIVIOR UK LIMITED IT
Temgesic 0,4 mg resoriblett not available 10625 INDIVIOR UK LIMITED FI Temgesic 0,4 mg resoriblett, sublingual
not available 11227 INDIVIOR UK LIMITED SE
Temgesic 0,4 mg resoribletti not available 10625 INDIVIOR UK LIMITED FI Temgesic 0,4 mg-Sublingualtabletten
not available 1-22041 INDIVIOR UK LIMITED AT
Temgesic 200 microgram sublingual tablets
not available PA 1657/2/1 INDIVIOR UK LIMITED IE
Temgesic 200 microgram Sublingual Tablets
not available PL36699/0004 INDIVIOR UK LIMITED UK
Temgesic 300 micrograms/ml, solution for injection
not available PA 1657/002/002 INDIVIOR UK LIMITED IE
Temgesic 400 microgram Sublingual Tablets
not available PL36699/0005 INDIVIOR UK LIMITED UK
Temgesic Injection 1ml not available PL 36699/0006 INDIVIOR UK LIMITED UK Temgesic Sublingualis 0,2 mg tabletten voor sublinguaal gebruik
not available 0703/02127474 INDIVIOR UK LIMITED LU
Temgesic Sublingualis 0,2 mg, comprimés sublinguaux
not available BE 122717 INDIVIOR UK LIMITED BE
Temgesic Sublingualis 0,2 mg, comprimés sublinguaux
not available 0703/02127474 INDIVIOR UK LIMITED LU
Temgesic Sublingualis 0,2 mg, Sublingualtabletten
not available BE 122717 INDIVIOR UK LIMITED BE
Temgesic Sublingualis 0,2 mg, Sublingualtabletten
not available 0703/02127474 INDIVIOR UK LIMITED LU
Temgesic Sublingualis 0,2 mg, tabletten voor sublinguaal gebruik
not available BE 122717 INDIVIOR UK LIMITED BE
List of nationally authorised medicinal products EMA/227734/2018 Page 87/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Temgesic sublingvaltablett 0,2 mg
not available 6800 INDIVIOR UK LIMITED NO
Temgesic sublingvaltablett 0,4 mg
not available 7615 INDIVIOR UK LIMITED NO
Temgesic, injektionsvæske, opløsning
not available 9926 INDIVIOR UK LIMITED DK
Temgesic, resoribletter, sublinguale
not available 10658 INDIVIOR UK LIMITED DK
Temgesic, resoribletter, sublinguale
not available 13628 INDIVIOR UK LIMITED DK
TEMGESIC® 0,3 mg Injektionslösung
not available 17.876 INDIVIOR UK LIMITED AT
TEMGESIC® Ampullen, 0,3 mg, Injektionslösung
not available 997.00.00 INDIVIOR UK LIMITED DE
TEMGESIC® forte sublingual, 0,4 mg, Sublingualtablette
not available 27138.00.00 INDIVIOR UK LIMITED DE
TEMGESIC® sublingual, 0,2 mg, Sublingualtablette
not available 997.00.01 INDIVIOR UK LIMITED DE
Tephine 200 microgram Sublingual Tablets
UK/H/1943/001 PL 04416/0956 SANDOZ LTD UK
Tephine 400 microgram Sublingual Tablets
UK/H/1943/002 PL 04416/0957 SANDOZ LTD UK
ThorBup 10 microgram/hour transdermal patch
DE/H/4397/002 PL 00240/0386 THORNTON & ROSS LTD UK
ThorBup 20 microgram/hour transdermal patch
DE/H/4397/003 PL 00240/0387 THORNTON & ROSS LTD UK
ThorBup 5 microgram/hour transdermal patch
DE/H/4397/001 PL 00240/0385 THORNTON & ROSS LTD UK
Transtec 52,5 mikrogramov/h transdermalni obliž
DE/H/0307/002 H/06/01559/002 GRÜNENTHAL GMBH SI
Transtec 70 mikrogramov/h transdermalni obliž
DE/H/0307/003 H/06/01559/003 GRÜNENTHAL GMBH SI
Transtec 35 microgram/u pleister voor transdermaal gebruik
DE/H/0307/001 BE233956 SA GRÜNENTHAL N.V. BE
List of nationally authorised medicinal products EMA/227734/2018 Page 88/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRANSTEC 35 microgramas/h, sistema transdérmico
DE/H/0307/001 3887981 GRÜNENTHAL S.A. PT
TRANSTEC 35 microgramas/h, sistema transdérmico
DE/H/0307/001 3887882 GRÜNENTHAL S.A. PT
TRANSTEC 35 microgramas/h, sistema transdérmico
DE/H/0307/001 4446886 GRÜNENTHAL S.A. PT
TRANSTEC 35 microgramas/h, sistema transdérmico
DE/H/0307/001 3887783 GRÜNENTHAL S.A. PT
Transtec 35 microgrammes/h dispositif transdermique
DE/H/0307/001 BE233956 SA GRÜNENTHAL N.V. BE
Transtec 35 microgrammes/h dispositif transdermique
DE/H/0307/001 2002040002 SA GRÜNENTHAL N.V. LU
Transtec 35 microgrammes/h dispositif transdermique
DE/H/0307/001 2002040002 SA GRÜNENTHAL N.V. LU
Transtec 35 microgrammes/h dispositif transdermique
DE/H/0307/001 2002040002 SA GRÜNENTHAL N.V. LU
Transtec 35 microgrammes/h dispositif transdermique
DE/H/0307/001 2002040002 SA GRÜNENTHAL N.V. LU
TRANSTEC 35 microgrammi /h cerotto transdermico
DE/H/0307/001 035568017/M GRÜNENTHAL ITALIA S.R.L. IT
TRANSTEC 35 microgrammi /h cerotto transdermico
DE/H/0307/001 035568029/M GRÜNENTHAL ITALIA S.R.L. IT
TRANSTEC 35 microgrammi /h cerotto transdermico
DE/H/0307/001 035568031/M GRÜNENTHAL ITALIA S.R.L. IT
Transtec 35 microgramos/hora parche transdérmico
DE/H/0307/001 64.684 GRÜNENTHAL PHARMA S.A. ES
List of nationally authorised medicinal products EMA/227734/2018 Page 89/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Transtec 35 microgramos/hora parche transdérmico
DE/H/0307/001 64.684 GRÜNENTHAL PHARMA S.A. ES
Transtec 35 mikrogram/ h transdermalni flaster
not available HR-H-479705231 GRÜNENTHAL GMBH HR
TRANSTEC 35 mikrogram/t depotplaster
DE/H/0307/001 34083 GRÜNENTHAL GMBH DK
Transtec 35 mikrogramm/h transzdermális tapasz
not available OGYI-T-8943/02 GRÜNENTHAL GMBH HU
Transtec 35 mikrogramm/h transzdermális tapasz
not available OGYI-T-8943/03 GRÜNENTHAL GMBH HU
Transtec 35 mikrogramm/h transzdermális tapasz
not available OGYI-T-8943/01 GRÜNENTHAL GMBH HU
Transtec 35 mikrogramov/h transdermalni obliž
DE/H/0307/001 H/06/01559/001 GRÜNENTHAL GMBH SI
TRANSTEC 35 μg/h not available 65/0294/02-S GRÜNENTHAL GMBH SK Transtec 35 μg/h, 20 mg, system transdermalny, plaster
not available 9661 GRÜNENTHAL GMBH PL
TRANSTEC 35 μg/h, transdermální náplast
not available 65/204/02-C GRÜNENTHAL GMBH CZ
TRANSTEC 35 μg/h, transdermální náplast
not available 65/204/02-C GRÜNENTHAL GMBH CZ
TRANSTEC 35 μg/h, transdermální náplast
not available 65/204/02-C GRÜNENTHAL GMBH CZ
Transtec 35 μg/uur, pleister voor transdermaal gebruik
not available RVG 32909 GRÜNENTHAL B.V. NL
TRANSTEC 52,5 µg/h not available 65/0295/02-S GRÜNENTHAL GMBH SK Transtec 52,5 microgram/u pleister voor transdermaal gebruik
DE/H/0307/002 BE233965 SA GRÜNENTHAL N.V. BE
TRANSTEC 52,5 microgramas/h, sistema transdérmico
DE/H/0307/002 3888088 GRÜNENTHAL S.A. PT
TRANSTEC 52,5 microgramas/h, sistema transdérmico
DE/H/0307/002 4446985 GRÜNENTHAL S.A. PT
List of nationally authorised medicinal products EMA/227734/2018 Page 90/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRANSTEC 52,5 microgramas/h, sistema transdérmico
DE/H/0307/002 3888286 GRÜNENTHAL S.A. PT
TRANSTEC 52,5 microgramas/h, sistema transdérmico
DE/H/0307/002 3888187 GRÜNENTHAL S.A. PT
Transtec 52,5 microgrammes/h dispositif transdermique
DE/H/0307/002 BE233965 SA GRÜNENTHAL N.V. BE
Transtec 52,5 microgrammes/h dispositif transdermique
DE/H/0307/002 2002040003 SA GRÜNENTHAL N.V. LU
Transtec 52,5 microgrammes/h dispositif transdermique
DE/H/0307/002 2002040003 SA GRÜNENTHAL N.V. LU
Transtec 52,5 microgrammes/h dispositif transdermique
DE/H/0307/002 2002040003 SA GRÜNENTHAL N.V. LU
Transtec 52,5 microgrammes/h dispositif transdermique
DE/H/0307/002 2002040003 SA GRÜNENTHAL N.V. LU
TRANSTEC 52,5 microgrammi /h cerotto transdermico
DE/H/0307/002 035568068/M GRÜNENTHAL ITALIA S.R.L. IT
TRANSTEC 52,5 microgrammi /h cerotto transdermico
DE/H/0307/002 035568043/M GRÜNENTHAL ITALIA S.R.L. IT
TRANSTEC 52,5 microgrammi /h cerotto transdermico
DE/H/0307/002 035568056/M GRÜNENTHAL ITALIA S.R.L. IT
Transtec 52,5 microgramos/hora parche transdérmico
DE/H/0307/002 64.685 GRÜNENTHAL PHARMA S.A. ES
Transtec 52,5 microgramos/hora parche transdérmico
DE/H/0307/002 64.685 GRÜNENTHAL PHARMA S.A. ES
Transtec 52,5 mikrogram/ h transdermalni flaster
not available HR-H-906948213 GRÜNENTHAL GMBH HR
List of nationally authorised medicinal products EMA/227734/2018 Page 91/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Transtec 52,5 mikrogramm/h transzdermális tapasz
not available OGYI-T-8944/02 GRÜNENTHAL GMBH HU
Transtec 52,5 mikrogramm/h transzdermális tapasz
not available OGYI-T-8944/01 GRÜNENTHAL GMBH HU
Transtec 52,5 mikrogramm/h transzdermális tapasz
not available OGYI-T-8944/03 GRÜNENTHAL GMBH HU
Transtec 52,5 μg/h, 30 mg, system transdermalny, plaster
not available 9662 GRÜNENTHAL GMBH PL
TRANSTEC 52,5 μg/h, transdermální náplast
not available 65/205/02-C GRÜNENTHAL GMBH CZ
TRANSTEC 52,5 μg/h, transdermální náplast
not available 65/205/02-C GRÜNENTHAL GMBH CZ
TRANSTEC 52,5 μg/h, transdermální náplast
not available 65/205/02-C GRÜNENTHAL GMBH CZ
Transtec 52,5 μg/uur, pleister voor transdermaal gebruik
not available RVG 32910 GRÜNENTHAL B.V. NL
Transtec 70 microgram/u pleister voor transdermaal gebruik
DE/H/0307/003 BE233974 SA GRÜNENTHAL N.V. BE
TRANSTEC 70 microgramas/h, sistema transdérmico
DE/H/0307/003 3888484 GRÜNENTHAL S.A. PT
TRANSTEC 70 microgramas/h, sistema transdérmico
DE/H/0307/003 4447082 GRÜNENTHAL S.A. PT
TRANSTEC 70 microgramas/h, sistema transdérmico
DE/H/0307/003 3888583 GRÜNENTHAL S.A. PT
TRANSTEC 70 microgramas/h, sistema transdérmico
DE/H/0307/003 3888385 GRÜNENTHAL S.A. PT
List of nationally authorised medicinal products EMA/227734/2018 Page 92/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Transtec 70 microgrammes/h dispositif transdermique
DE/H/0307/003 BE233974 SA GRÜNENTHAL N.V. BE
Transtec 70 microgrammes/h dispositif transdermique
DE/H/0307/003 2002040004 SA GRÜNENTHAL N.V. LU
Transtec 70 microgrammes/h dispositif transdermique
DE/H/0307/003 2002040004 SA GRÜNENTHAL N.V. LU
Transtec 70 microgrammes/h dispositif transdermique
DE/H/0307/003 2002040004 SA GRÜNENTHAL N.V. LU
Transtec 70 microgrammes/h dispositif transdermique
DE/H/0307/003 2002040004 SA GRÜNENTHAL N.V. LU
TRANSTEC 70 microgrammi /h cerotto transdermico
DE/H/0307/003 035568070/M GRÜNENTHAL ITALIA S.R.L. IT
TRANSTEC 70 microgrammi /h cerotto transdermico
DE/H/0307/003 035568082/M GRÜNENTHAL ITALIA S.R.L. IT
TRANSTEC 70 microgrammi /h cerotto transdermico
DE/H/0307/003 035568094/M GRÜNENTHAL ITALIA S.R.L. IT
Transtec 70 microgramos/hora parche transdérmico
DE/H/0307/003 64.686 GRÜNENTHAL PHARMA S.A. ES
Transtec 70 microgramos/hora parche transdérmico
DE/H/0307/003 64.686 GRÜNENTHAL PHARMA S.A. ES
Transtec 70 mikrogram/ h transdermalni flaster
not available HR-H-025230904 GRÜNENTHAL GMBH HR
TRANSTEC 70 mikrogram/t depotplaster
DE/H/0307/003 34085 GRÜNENTHAL GMBH DK
Transtec 70 mikrogramm/h transzdermális tapasz
not available OGYI-T-8945/02 GRÜNENTHAL GMBH HU
Transtec 70 mikrogramm/h transzdermális tapasz
not available OGYI-T-8945/01 GRÜNENTHAL GMBH HU
Transtec 70 mikrogramm/h transzdermális tapasz
not available OGYI-T-8945/03 GRÜNENTHAL GMBH HU
List of nationally authorised medicinal products EMA/227734/2018 Page 93/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRANSTEC 70 μg/h Transdermálna náplasť
not available 65/0296/02-S GRÜNENTHAL GMBH SK
Transtec 70 μg/h, 40 mg, system transdermalny, plaster
not available 9663 GRÜNENTHAL GMBH PL
TRANSTEC 70 μg/h, transdermální náplast
not available 65/206/02-C GRÜNENTHAL GMBH CZ
TRANSTEC 70 μg/h, transdermální náplast
not available 65/206/02-C GRÜNENTHAL GMBH CZ
TRANSTEC 70 μg/h, transdermální náplast
not available 65/206/02-C GRÜNENTHAL GMBH CZ
Transtec 70 μg/uur, pleister voor transdermaal gebruik
not available RVG 32911 GRÜNENTHAL B.V. NL
Transtec PRO 35 Mikrogramm/h, transdermales Pflaster
DE/H/0307/001 47055.00.00 GRÜNENTHAL GMBH DE
Transtec PRO 52,5 Mikrogramm/h, transdermales Pflaster
DE/H/0307/002 47055.01.00 GRÜNENTHAL GMBH DE
Transtec PRO 70 Mikrogramm/h, transdermales Pflaster
DE/H/0307/003 47055.02.00 GRÜNENTHAL GMBH DE
Transtec, depotplaster DE/H/0307/002 34084 GRÜNENTHAL GMBH DK TRANSTEC® 35 micrograms/h Transdermal Patch
DE/H/0307/001 PA 1032/001/001 GRÜNENTHAL GMBH IE
TRANSTEC® 35 micrograms/h transdermal patch
DE/H/0307/001 PL 04539/0014 GRÜNENTHAL GMBH UK
Transtec® 35 Mikrogramm/h - transdermales Pflaster
DE/H/0307/001 1-24396 GRÜNENTHAL GES. M.B.H. AT
Transtec® 52,5 Mikrogramm/h - transdermales Pflaster
DE/H/0307/002 1-24397 GRÜNENTHAL GES. M.B.H. AT
List of nationally authorised medicinal products EMA/227734/2018 Page 94/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRANSTEC® 52.5 micrograms/h Transdermal Patch
DE/H/0307/002 PA 1032/001/002 GRÜNENTHAL GMBH IE
TRANSTEC® 52.5 micrograms/h transdermal patch
DE/H/0307/002 PL 04539/0015 GRÜNENTHAL GMBH UK
TRANSTEC® 70 micrograms/h Transdermal Patch
DE/H/0307/003 PA 1032/001/003 GRÜNENTHAL GMBH IE
TRANSTEC® 70 micrograms/h transdermal patch
DE/H/0307/003 PL 04539/0016 GRÜNENTHAL GMBH UK
Transtec® 70 Mikrogramm/h - transdermales Pflaster
DE/H/0307/003 1-24398 GRÜNENTHAL GES. M.B.H. AT
Tranzileve 10 microgram/hour Transdermal Patch
UK/H/6715/002 PA 1887/006/002 ALISSA HEALTHCARE RESEARCH LIMITED
IE
Tranzileve 10 microgram/hour Transdermal Patch
DE/H/4395/002 PL 30322/0017 ALISSA HEALTHCARE RESEARCH LIMITED
UK
Tranzileve 20 microgram/hour Transdermal Patch
UK/H/6715/003 PA 1887/006/003 ALISSA HEALTHCARE RESEARCH LIMITED
IE
Tranzileve 20 microgram/hour Transdermal Patch
UK/H/6715/003 PL 30322/0018 ALISSA HEALTHCARE RESEARCH LIMITED
UK
Tranzileve 5 microgram/hour Transdermal Patch
UK/H/6715/001 PA 1887/006/001 ALISSA HEALTHCARE RESEARCH LIMITED
IE
Tranzileve 5 microgram/hour Transdermal Patch
DE/H/4395/001 PL 30322/0016 ALISSA HEALTHCARE RESEARCH LIMITED
UK
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215010 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215022 GRÜNENTHAL ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/227734/2018 Page 95/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215034 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215046 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215059 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215061 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215073 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215085 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215097 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215111 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215109 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 35 microgrammi /h cerotto transdermico
DE/H/0308/001 044215123 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215135 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215147 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215150 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215162 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215174 GRÜNENTHAL ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/227734/2018 Page 96/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215186 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215198 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215200 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215212 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215224 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215236 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 52,5 microgrammi /h cerotto transdermico
DE/H/0308/002 044215248 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215251 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215263 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215275 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215287 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215299 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215301 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215313 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215325 GRÜNENTHAL ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/227734/2018 Page 97/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215337 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215349 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215352 GRÜNENTHAL ITALIA S.R.L. IT
TRIQUISIC 70 microgrammi /h cerotto transdermico
DE/H/0308/003 044215364 GRÜNENTHAL ITALIA S.R.L. IT
Turgeon 35 micrograms/h Transdermal Patch
DE/H/5078/001 PL 00289/1965 TEVA UK LIMITED UK
Turgeon 52.5 micrograms/h Transdermal Patch
DE/H/5078/002 PL 00289/1966 TEVA UK LIMITED UK
Turgeon 70 micrograms/h Transdermal Patch
DE/H/5078/003 PL 00289/1967 TEVA UK LIMITED UK
Бупренорфин 52,5 микрограма/час трансдермален пластир
DE/H/3646/002 20130161 ACTAVIS GROUP PTC EHF. BG
Бупренорфин G.L. 4 mg сублингвални таблетки
DE/H/2804/002 20120089 G.L. PHARMA GMBH BG
Бупренорфин G.L. 8 mg сублингвални таблетки
DE/H/2804/003 20120088 G.L. PHARMA GMBH BG
Бупренорфин G.L.2 mg сублингвални таблетки
DE/H/2804/001 20120090 G.L. PHARMA GMBH BG
Бупренорфин Актавис 35 микрограма/час трансдермален пластир
DE/H/3646/001 20130163 ACTAVIS GROUP PTC EHF. BG
Бупренорфин Актавис 70 микрограма/час трансдермален пластир
DE/H/3646/003 20130162 ACTAVIS GROUP PTC EHF. BG
Бупренорфин Сандоз 35 микрограма/час трансдермален пластир
DE/H/4515/001 20160228 SANDOZ PHARMACEUTICALS D.D.
BG
Бупренорфин Сандоз 52,5 микрограма/час трансдермален пластир
DE/H/4515/002 2016229 SANDOZ PHARMACEUTICALS D.D.
BG
List of nationally authorised medicinal products EMA/227734/2018 Page 98/98
Product name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Бупренорфин Сандоз 70 микрограма/час трансдермален пластир
DE/H/4515/003 20160230 SANDOZ PHARMACEUTICALS D.D.
BG