pending marketing authorisation applications

Pending marketing authorisation applicationsSituation 17/05/2021 08:58

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The Finnish Medicines Agency Fimea makes every effort to ensure that the information is accurate and up to date, but individual errors can occur.The information contained in the document is based on the applicant's notification and the situation at the time of submitting the document.

Applicant Nature of the application Application receipt date Number of applications

A02AX Antacids, other combinations Calcium carbonate, Magnesium carbonate, heavy, Alginic acid

Bayer Oy Marketing authorisation application 30/07/2020 1

A03AB02 glycopyrronium bromide Glycopyrronium bromide

Clinigen Healthcare B.V. Marketing authorisation application 31/10/2019 1EQL PHARMA AB Marketing authorisation application 09/04/2021 1

A03BB01 butylscopolamine Hyoscine butylbromide

Macure Pharma ApS Marketing authorisation application 27/10/2020 1

A03FA07 itopride Itopride hydrochlorid

Kappler Pharma Consult GmbH Marketing authorisation application 01/04/2020 1

A04AA01 ondansetron Ondansetron hydrochloride dihydrate

Accord Healthcare S.L.U. Marketing authorisation application 27/12/2018 2Fresenius Kabi Ab Marketing authorisation application 11/12/2020 2

A04AA01 ondansetron Ondansetron

Akciju Sabiedriba "Grindeks" Marketing authorisation application 01/10/2020 1

A05AA02 ursodeoxycholic acid Ursodeoxycholic acid

PRO.MED.CS Praha a.s. Marketing authorisation application 31/08/2020 1

A07DA03 loperamide Loperamide hydrochloride

Tenshi Kaizen B.V. Marketing authorisation application 26/07/2019 1

A07EA06 budesonide Budesonide

Medical Valley Invest AB Marketing authorisation application 01/02/2021 1

A07EC02 mesalazine Mesalazine

Paranova Oy Parallel import 12/01/2021 1

A08 ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS Phentermine hydrochloride, Topiramate

VIVUS BV Marketing authorisation application 31/07/2019 4

A09AA02 multienzymes (lipase, protease etc.) Pancreas powder

Abigo Medical AB Marketing authorisation application 14/07/2020 2

A10BA02 metformin Metformin hydrochloride, Metformin

Teva B.V. Marketing authorisation application 15/03/2021 3


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A10BA02 metformin Metformin hydrochloride

Accord Healthcare B.V. Marketing authorisation application 22/07/2019 2Zentiva, k.s. Marketing authorisation application 04/05/2020 3Accord Healthcare B.V. Marketing authorisation application 01/06/2020 3Kappler Pharma Consult GmbH Marketing authorisation application 22/12/2020 3ARRIELLO s.r.o. Marketing authorisation application 23/12/2020 3Sandoz A/S Marketing authorisation application 09/02/2021 3

A10BD07 metformin and sitagliptin Metformin hydrochloride, Sitagliptin hydrochloride


A10BD07 metformin and sitagliptin Sitagliptin hydrochloride monohydrate, Metformin hydrochloride

Orion Corporation Marketing authorisation application 27/12/2019 2Hexal A/S Marketing authorisation application 30/10/2020 2AS GRINDEKS (JSC GRINDEKS) Marketing authorisation application 20/11/2020 2Reddy Holding GmbH Marketing authorisation application 15/02/2021 2

A10BD07 metformin and sitagliptin Sitagliptin hydrochloride, Metformin hydrochloride

Stada Arzneimittel AG Marketing authorisation application 01/10/2019 2Glenmark Arzneimittel GmbH Marketing authorisation application 28/05/2020 2Zentiva, k.s. Marketing authorisation application 02/07/2020 2

A10BD07 metformin and sitagliptin Sitagliptin, Metformin hydrochloride

Genepharm S.A. Marketing authorisation application 09/03/2021 2

A10BD08 metformin and vildagliptin Vildagliptin, Metformin hydrochloride

KRKA, d.d., Novo mesto Marketing authorisation application 05/11/2019 2Stada Arzneimittel AG Marketing authorisation application 20/12/2019 2

A10BH01 sitagliptin Sitagliptin hydrochloride monohydrate

STADA Arzneimittel AG Marketing authorisation application 02/08/2019 3Mylan AB Marketing authorisation application 20/12/2019 3APC INSTYTUT Sp. z o.o. Marketing authorisation application 30/04/2020 3Avansor Pharma Oy Marketing authorisation application 30/04/2020 2Medical Pharmaquality SA Marketing authorisation application 04/05/2020 3Hexal A/S Marketing authorisation application 19/10/2020 3AS GRINDEKS (JSC GRINDEKS) Marketing authorisation application 16/11/2020 3

A10BH01 sitagliptin Sitagliptin hydrochloride

Glenmark Arzneimittel GmbH Marketing authorisation application 28/05/2020 3Zentiva, k.s. Marketing authorisation application 22/06/2020 3


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A10BH02 vildagliptin Vildagliptin

STADA Arzneimittel AG Marketing authorisation application 01/02/2019 1Mylan AB Marketing authorisation application 29/10/2019 1

A10BH05 linagliptin Linagliptin

Stada Arzneimittel AG Marketing authorisation application 30/01/2020 1

A10BK01 dapagliflozin Dapagliflozin


A11CC03 alfacalcidol Alfacalcidol

Pharma scientific research s.r.o. Marketing authorisation application 09/04/2019 3

A11CC05 colecalciferol (vitamin D3) Colecalciferol

Fresenius Kabi Ab Marketing authorisation application 08/09/2020 1

A11DA01 thiamine (vit B1) Thiamine hydrochloride

Laboratoires Sterop NV Marketing authorisation application 14/03/2018 2

A16AX12 trientine Trientine dihydrochloride

Waymade B.V. Marketing authorisation application 21/12/2020 1

B01AB05 enoxaparin Enoxaparin sodium

BE Pharma B.V. Marketing authorisation application 10/08/2020 7

B01AB09 danaparoid Danaparoid sodium


B01AC11 iloprost Iloprost trometamol

Zentiva, k.s. Marketing authorisation application 25/10/2019 2Orifarm Oy Parallel import 01/03/2021 1

B01AC21 treprostinil Treprostinil sodium

Laboratorios Tillomed Spain S.L.U Marketing authorisation application 03/12/2018 4Reddy Holding GmbH Marketing authorisation application 30/09/2020 4

B01AC24 ticagrelor Ticagrelorum

STADA Arzneimittel AG Marketing authorisation application 17/12/2018 2Mylan AB Marketing authorisation application 05/03/2020 2Avansor Pharma Oy Marketing authorisation application 01/02/2021 2

B01AD02 alteplase Alteplase

Orifarm Oy Parallel import 01/03/2021 1


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B01AE07 dabigatran etexilate Dabigatran etexilate mesilate

Dose Innova S.L. Marketing authorisation application 29/07/2020 3STADA Arzneimittel AG Marketing authorisation application 01/09/2020 3Sandoz A/S Marketing authorisation application 04/09/2020 3Orion Corporation Marketing authorisation application 06/11/2020 3

B01AF01 rivaroxaban Rivaroxaban

Avansor Pharma Oy Marketing authorisation application 01/07/2019 4Hexal A/S Marketing authorisation application 03/12/2020 5Orion Corporation Orion Pharma Marketing authorisation application 29/12/2020 4Reddy Holding GmbH Marketing authorisation application 08/03/2021 4Stada Arzneimittel AG Marketing authorisation application 16/04/2021 5

B01AF02 apixaban Apixaban

Stada Arzneimittel AG Marketing authorisation application 31/10/2019 2Sandoz A/S Marketing authorisation application 01/11/2019 2Mylan AB Marketing authorisation application 28/02/2020 2KRKA, d.d., Novo mesto Marketing authorisation application 02/10/2020 2

B02AB02 alfa1 antitrypsin Alpha-1 Proteinase inhibitor

Takeda Manufacturing Austria AG Marketing authorisation application 26/03/2021 2

B02BD06 von Willebrand factor and coagulation factor VIII in combination Factor VIII (antihaemophilic factor), Human von Willebrand factor

CSL Behring GmbH Marketing authorisation application 22/03/2021 3

B03AC Iron, parenteral preparations Ferric carboxymaltose

Sandoz A/S Marketing authorisation application 31/12/2020 1

B05AA01 albumin Human albumin solution

Instituto Grifols S.A. Marketing authorisation application 14/01/2021 2

B05BA01 amino acids Alanine, Arginine, Aspartic acid, Glutamic acid, Glycine, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Proline, Serine, Threonine, Tryptophane, Tyrosine, Valine, Sodium glycerophosphate, hydrated, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate

Baxter Oy Marketing authorisation application 27/06/2019 4

B05BA01 amino acids Alanine, Arginine, Aspartic acid, Glutamic acid, Glycine, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Proline, Serine, Threonine, Tryptophane, Tyrosine, Valine

Baxter Oy Marketing authorisation application 27/06/2019 4

B05BA10 combinations Alanine, Arginine, Glycine hydrochloride, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Proline, Serine, Taurine, Threonine, Tryptophane, Tyrosine, Valine, Calcium chloride dihydrate, Sodium glycerophosphate, hydrated, Magnesium sulfate heptahydrate, Potassium chloride, Sodium acetate trihydrate, ZINC SULFATE HEPTAHYDRATE, Glucose monohydrate, Soya-bean oil, refined, Triglycerides, medium-chain, Olive oil, refined, Fish oil, rich in omega-3-acids


B05BB01 electrolytes Calcium gluconate ad iniectabile

Paranova Oy Parallel import 26/02/2021 12care4 ApS Parallel import 10/03/2021 1


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B05CX10 combinations Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Histidine, Histidine hydrochloride, Tryptophane, Mannitol, Potassium hydroxide

SALF SpA Laboratorio Farmacologico Marketing authorisation application 14/11/2017 1

B05XA16 cardioplegia solutions Procaine hydrochloride, Magnesium sulfate heptahydrate, Potassium chloride, Xylitol

MIT Gesundheit GmbH Marketing authorisation application 20/04/2016 1

B05XC Vitamins Retinol palmitate, Colecalciferol, Alpha-tocopherol, rasemic, Ascorbic acid, Cocarboxyl tetrahydrate, Riboflavin sodium fosfate, Pyridoxine hydrochloride, Cyanocobalamin, Folic acid, Dexpanthenol, Biotin, Nicotinamide


B05ZB Hemofiltrates Trisodium citrate dihydrate

Fresenius Medical Care Deutschland GmbH Marketing authorisation application 31/03/2020 1

B06AC02 icatibant Icatibant acetate, Icatibant

Universal Farma S.L. Marketing authorisation application 14/04/2021 1

B06AC02 icatibant Icatibant acetate

Avansor Pharma Oy Marketing authorisation application 16/07/2020 1Fresenius Kabi Ab Marketing authorisation application 16/07/2020 1Glenmark Arzneimittel GmbH Marketing authorisation application 16/07/2020 1STADA Arzneimittel AG Marketing authorisation application 16/07/2020 1Teva B.V. Marketing authorisation application 16/07/2020 1Universal Farma S.L. Marketing authorisation application 16/07/2020 1Zentiva, k.s. Marketing authorisation application 16/07/2020 1Midas Pharma GmbH Marketing authorisation application 25/08/2020 1Sandoz A/S Marketing authorisation application 31/03/2021 1

C01BD01 amiodarone Amiodarone hydrochloride

Accord Healthcare B.V. Marketing authorisation application 25/02/2019 1

C01BD05 ibutilide Ibutilide fumarate


C01CA03 norepinephrine Norepinephrine

Hameln Pharma Plus GmbH Marketing authorisation application 19/12/2019 1Fresenius Kabi Ab Marketing authorisation application 14/04/2020 1Laboratoire Aguettant Marketing authorisation application 09/06/2020 1

C01CA17 midodrine Midodrine hydrochloride

Brancaster Pharma Ireland Ltd. Marketing authorisation application 14/02/2020 1

C01CA26 ephedrine Ephedrine hydrochloride

Sintetica GmbH Marketing authorisation application 15/03/2019 22Care4 Generics ApS Marketing authorisation application 30/09/2020 1


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C01CX08 levosimendan Levosimendan

Tillomed Pharma GmbH Marketing authorisation application 29/11/2019 1Altan Pharma ltd Marketing authorisation application 17/03/2020 1Amdipharm Limited Marketing authorisation application 12/08/2020 1Fresenius Kabi Ab Marketing authorisation application 12/08/2020 1STADA Arzneimittel AG Marketing authorisation application 20/10/2020 1Akciju sabiedriba Kalceks Marketing authorisation application 22/12/2020 1Carinopharm GmbH Marketing authorisation application 05/03/2021 1

C01EA01 alprostadil Alprostadil


C02AC01 clonidine Clonidine hydrochloride

2Care4 Generics ApS Marketing authorisation application 30/07/2020 1

C02KX01 bosentan Bosentan monohydrate


C03DA04 eplerenone Eplerenone


C05BB02 polidocanol Lauromacrogolum 400

Paranova Oy Parallel import 23/02/2021 1Orifarm Oy Parallel import 01/03/2021 3

C07AB12 nebivolol Nebivolol hydrochloride


C08CA05 nifedipine Nifedipine


C08CA13 lercanidipine Lercanidipine hydrochloride


C09DX01 valsartan, amlodipine and hydrochlorothiazide Amlodipine besylate, Valsartan, Hydrochlorothiazide

Mylan AB Marketing authorisation application 29/08/2019 5

C10BA06 rosuvastatin and ezetimibe Rosuvastatin calcium, Ezetimibe


D01AC01 clotrimazole Clotrimazole

Bayer Oy Marketing authorisation application 30/04/2020 1

D01AC08 ketoconazole Ketoconazole



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D05AX52 calcipotriol, combinations Calcipotriol hydrate, Betamethasone dipropionate

Orifarm Generics A/S Marketing authorisation application 06/05/2020 1

D05AX52 calcipotriol, combinations Calcipotriol, Betamethasone dipropionate

MC2 Therapeutics A/S Marketing authorisation application 01/07/2020 1

D08AC52 chlorhexidine, combinations Chlorhexidine digluconate, 2-Propanol

Becton Dickinson France SAS Marketing authorisation application 22/05/2020 1

D08AG02 povidone-iodine Polyvidone-iodine

Drehm Pharma GmbH Marketing authorisation application 02/07/2019 1Mundipharma Oy Marketing authorisation application 18/07/2019 1

D11AA01 glycopyrronium Glycopyrronium bromide

Dr. August Wolff GmbH & Co. KG Arzneimittel Marketing authorisation application 26/02/2021 1

D11AH01 tacrolimus Tacrolimus monohydrate

Pierre Fabre Dermatologie Marketing authorisation application 30/09/2014 1

D11AH01 tacrolimus Tacrolimus

Accord Healthcare Limited Marketing authorisation application 30/09/2014 1

D11AX10 finasteride Finasteride

2Care4 Generics ApS Marketing authorisation application 27/09/2019 1

G03AA07 levonorgestrel and ethinylestradiol Ethinylestradiol, Levonorgestrel

Abacus Medicine A/S Parallel import 24/09/2020 1

G03AA10 gestodene and ethinylestradiol Ethinylestradiol, Gestodene, Ethinylestradiol, Gestodene

Gedeon Richter Plc Marketing authorisation application 30/03/2020 1

G03AC09 desogestrel Desogestrel

Laboratorios León Farma S.A. Marketing authorisation application 02/03/2020 1

G03BA03 testosterone Testosterone

Laboratoires Besins International Marketing authorisation application 10/04/2020 1

G03CC Estrogens, combinations with other drugs Lactobacillus acidophilus, lyophilized, Estriol

Exeltis Healthcare Marketing authorisation application 01/10/2020 1

G03DA04 progesterone Progesterone

Exeltis Healthcare Marketing authorisation application 14/06/2019 2

G03DB08 dienogest Dienogest

Paranova Oy Parallel import 15/01/2021 1Stragen Nordic A/S Marketing authorisation application 22/03/2021 1


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G03GA01 chorionic gonadotrophin Chorionic gonadotrophin

Laboratoires GENEVRIER Marketing authorisation application 30/10/2019 1

G03GA02 human menopausal gonadotrophin Menotropine

Ferring Lääkkeet Oy Marketing authorisation application 15/04/2020 2IBSA Farmaceutici Italia S.r.l Marketing authorisation application 22/07/2020 2

G03HB01 cyproterone and estrogen Cyproterone acetate, Ethinylestradiol


G03XB01 mifepristone Mifepristone


G04BD11 fesoterodine Fesoterodini fumarate

STADA Arzneimittel AG Marketing authorisation application 26/03/2020 2Accord Healthcare B.V. Marketing authorisation application 31/03/2020 1

G04BD12 mirabegron Mirabegron


G04BE03 sildenafil Sildenafil citrate

Orion Corporation Marketing authorisation application 22/06/2020 2

G04BE08 tadalafil Tadalafil


H01BA01 vasopressin (argipressin) Argipressin

Pharmexon Consulting SRO Marketing authorisation application 31/08/2020 1

H01BA02 desmopressin Desmopressin acetate

Billev Pharma ApS Marketing authorisation application 05/11/2020 3

H01BA04 terlipressin Terlipressin


H01BB03 carbetocin Carbetocin

Laboratoire Aguettant Marketing authorisation application 03/02/2021 1

H01CB03 lanreotide Lanreotide acetate

Amdipharm Limited Marketing authorisation application 20/03/2019 3Paranova Oy Parallel import 10/11/2020 1

H01CC01 ganirelix Ganirelix acetate



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H02AB02 dexamethasone Dexamethasone sodium phosphate

S.MED Pharmavertriebsgesellsch Marketing authorisation application 29/05/2019 1Abboxia AB Marketing authorisation application 12/12/2019 1Akciju sabiedriba Kalceks Marketing authorisation application 16/11/2020 1Fresenius Kabi AB Marketing authorisation application 18/12/2020 12care4 ApS Parallel import 18/03/2021 1

H02AB02 dexamethasone Dexamethasone


H02AB04 methylprednisolone Methylprednisolone sodium succinate


H02AB04 methylprednisolone Methylprednisolone, Methylprednisolone sodium succinate


H02AB08 triamcinolone Triamcinolone hexacetonide

2care4 ApS Parallel import 23/02/2021 1

H02AB09 hydrocortisone Hydrocortisone sodium succinate


H02AB09 hydrocortisone Hydrocortisone

ACE Pharmaceuticals BV Marketing authorisation application 14/04/2021 4

H02AB13 deflazacort Deflazacort

Vital Pharma Nordic ApS Marketing authorisation application 02/01/2019 2

H03AA01 levothyroxine sodium Levothyroxine sodium

Aristo Pharma GmbH Marketing authorisation application 11/09/2020 3

H05AA02 teriparatide Teriparatide

Ambio Pharma Europe Marketing authorisation application 19/09/2019 1

H05BX01 cinacalcet Cinacalcet hydrochloride


J01AA12 tigecycline Tigecycline

EQL PHARMA AB Marketing authorisation application 28/01/2020 1

J01CE08 benzylpenicillin, benzathine Benzathine benzylpenicillin


J01CF02 cloxacillin Cloxacillin sodium

Stragen Nordic A/S Marketing authorisation application 29/03/2019 2


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J01CR02 amoxicillin and beta-lactamase inhibitor Amoxicillin sodium, Potassium clavulanate


J01DB01 cefalexin Cefalexin monohydrate

Antibiotice Marketing authorisation application 23/06/2020 1

J01DH02 meropenem Meropenem trihydrate

Antibiotice Marketing authorisation application 27/02/2020 1Tenshi Kaizen B.V. Marketing authorisation application 21/08/2020 2Medical Valley Invest AB Marketing authorisation application 07/10/2020 2Pfizer Oy Marketing authorisation application 23/03/2021 1

J01FA10 azithromycin Azithromycin


J01FF01 clindamycin Clindamycin phosphate

Abcur AB Marketing authorisation application 01/10/2020 1

J01GB01 tobramycin Tobramycin

Promedica S.r.l. Marketing authorisation application 11/03/2021 1

J01XA02 teicoplanin Teichoplanin


J02AA01 amphotericin Amphotericin b


J02AC01 fluconazole Fluconazole

Vitabalans Oy Marketing authorisation application 30/06/2020 1ratiopharm GmbH Marketing authorisation application 04/12/2020 1Orifarm Oy Parallel import 01/03/2021 1

J05AB12 cidofovir Cidofovir dihydrate

ASCENDERS PHARMA LIMITED Marketing authorisation application 01/10/2019 1

J05AB14 valganciclovir Valganciclovir hydrochloride


J05AD01 foscarnet Foscarnet sodium

Tillomed Pharma GmbH Marketing authorisation application 12/06/2020 1

J06BA01 immunoglobulins, normal human, for extravascular adm. Human normal immunoglobulin

Instituto Grifols S.A. Marketing authorisation application 07/07/2020 1

L01AA01 cyclophosphamide Cyclophosphamide monohydrate



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L01AA03 melphalan Melphalan hydrochloride


L01AA06 ifosfamide Ifosfamide


L01AA09 bendamustine Bendamustine hydrochloride


L01AC01 thiotepa Thiotepa


L01AD01 carmustine Carmustine

Accord Healthcare B.V. Marketing authorisation application 25/10/2019 1Waymade B.V. Marketing authorisation application 03/08/2020 1Accord Healthcare B.V. Marketing authorisation application 01/12/2020 2

L01BA01 methotrexate Methotrexate

Accord Healthcare Limited Marketing authorisation application 20/11/2017 10

L01BA04 pemetrexed Pemetrexed disodium

Koanaa Healthcare GmbH Marketing authorisation application 31/03/2020 1

L01BA04 pemetrexed Pemetrexed ditromethamine dihydrate

Reddy Holding GmbH Marketing authorisation application 01/12/2020 3

L01BC02 fluorouracil Fluorouracil


L01BC07 azacitidine Azacitidine

EVER Valinject GmbH Marketing authorisation application 28/03/2019 1Nordic Prime ApS Marketing authorisation application 02/04/2019 1Ascenders Pharma Limited Marketing authorisation application 25/09/2019 1Laboratorios Lorien S.L. Marketing authorisation application 31/03/2020 1Glenmark Arzneimittel GmbH Marketing authorisation application 14/09/2020 1Eignapharma S.L. Marketing authorisation application 18/12/2020 1

L01CA04 vinorelbine Vinorelbine tartrate

PharmSol Europe Limited Marketing authorisation application 03/11/2020 3Accord Healthcare B.V. Marketing authorisation application 31/03/2021 3

L01CD01 paclitaxel Paclitaxel

Strides Arcolab International Limited Marketing authorisation application 07/04/2010 1


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L01CD04 cabazitaxel Cabazitaxel

Vivanta Generics s.r.o. Marketing authorisation application 29/03/2019 1Kappler Pharma Consult GmbH Marketing authorisation application 29/11/2019 1Fresenius Kabi Ab Marketing authorisation application 26/03/2021 1

L01DB01 doxorubicin Doxorubicin hydrochloride


L01DB06 idarubicin Idarubicin hydrochloride


L01DB07 mitoxantrone Mitoxantrone hydrochloride


L01EA01 imatinib Imatinib mesylate


L01EA02 dasatinib Dasatinib


L01EG02 everolimus Everolimus

Ethypharm Marketing authorisation application 16/03/2021 3

L01EX01 sunitinib Sunitinib malate

Avansor Pharma Oy Marketing authorisation application 20/12/2019 3KRKA, d.d., Novo mesto Marketing authorisation application 31/03/2020 3Vivanta Generics s.r.o. Marketing authorisation application 28/09/2020 4

L01EX03 pazopanib Pazopanib hydrochloride

PharOS - Pharmaceutical Oriented Services Ltd Marketing authorisation application 07/12/2020 2

L01XF03 bexarotene Bexarotene


L01XG01 bortezomib Bortezomib

Koanaa Healthcare GmbH Marketing authorisation application 28/05/2019 1Baxter Holding B.V. Marketing authorisation application 28/05/2020 1DiaMed Beratungsgesellschaft für pharmaz. Unternehmen mbH Marketing authorisation application 29/07/2020 1Reddy Holding GmbH Marketing authorisation application 29/10/2020 1

L01XX Other antineoplastic agents Irinotecan hydrochloride trihydric

Sun Pharmaceutical Industries B.V Marketing authorisation application 18/12/2020 1

L01XX02 asparaginase CRISANTASPASE

Porton Biopharma Limited Marketing authorisation application 26/04/2021 1


13



L02BA03 fulvestrant Fulvestrant

Reddy Holding GmbH Marketing authorisation application 17/09/2020 1Paranova Oy Parallel import 07/04/2021 1

L02BG06 exemestane Exemestane


L02BX03 abiraterone Abiraterone acetate

Avansor Pharma Oy Marketing authorisation application 09/09/2019 2Glenmark Arzneimittel GmbH Marketing authorisation application 09/09/2019 1Sandoz A/S Marketing authorisation application 03/12/2019 1Sandoz A/S Marketing authorisation application 31/03/2020 1STADA Arzneimittel AG Marketing authorisation application 03/07/2020 1TEVA Pharma B.V. Marketing authorisation application 01/12/2020 1Medical Valley Invest AB Marketing authorisation application 18/01/2021 1

L04AA03 antilymphocyte immunoglobulin Anti t-lymphocyte immunoglobulin (Equine) (hATG)

Pfizer Oy Marketing authorisation application 30/01/2020 1

L04AA18 everolimus Everolimus


L04AA27 fingolimod Fingolimod hydrochloride

Sandoz A/S Marketing authorisation application 15/04/2019 1Bausch Health Ireland Limited Marketing authorisation application 25/10/2019 1Tillomed Pharma GmbH Marketing authorisation application 01/11/2019 1KRKA, d.d., Novo mesto Marketing authorisation application 09/12/2019 1Sandoz A/S Marketing authorisation application 28/12/2020 1

L04AX04 lenalidomide Lenalidomide ammonium chloride

AS GRINDEKS (JSC GRINDEKS) Marketing authorisation application 28/09/2020 7

L04AX04 lenalidomide Lenalidomide

Cipla Europe NV Marketing authorisation application 07/08/2019 5STADA Nordic ApS Marketing authorisation application 18/12/2020 7Fresenius Kabi Ab Marketing authorisation application 19/02/2021 6

L04AX05 pirfenidone Pirfenidone

Sandoz A/S Marketing authorisation application 03/03/2021 2ratiopharm GmbH Marketing authorisation application 03/03/2021 2STADA Arzneimittel AG Marketing authorisation application 04/03/2021 2

M01AB15 ketorolac Ketorolac tromethamine



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M01AE01 ibuprofen Ibuprofen lysine, Ibuprofen

Vitabalans Oy Marketing authorisation application 22/01/2021 1

M01AE01 ibuprofen Ibuprofen lysine

Vitabalans Oy Marketing authorisation application 31/01/2018 1

M01AE01 ibuprofen Ibuprofen

Zentiva, k.s. Marketing authorisation application 18/12/2019 5Strides Pharma (Cyprus) Limited Marketing authorisation application 06/05/2020 4Fair-Med Healthcare GmbH Marketing authorisation application 07/05/2020 4

M01AE02 naproxen Naproxen


M03AB01 suxamethonium Suxamethonium chloride


M03AX01 botulinum toxin Clostridium botulinum toxin type A haemagglutinin complex

Ipsen Pharma Marketing authorisation application 22/11/2019 1

M03AX01 botulinum toxin Clostridium botulinum type A neurotoxin (150kD)


M03AX01 botulinum toxin Clostridium botulinum type A neurotoxin complex (900 kD)


M03BX02 tizanidine Tizanidine

G.L. Pharma GmbH Marketing authorisation application 12/02/2020 2

M05BA04 alendronic acid Sodium alendronate trihydrate


N01AB06 isoflurane Isoflurane

Sedana Medical AB Marketing authorisation application 27/11/2020 1

N01AF03 thiopental Thiopental sodium

ELC GROUP S.R.O. Marketing authorisation application 16/04/2021 2

N01BB03 mepivacaine Mepivacaine hydrochloride

Laboratorios Inibsa S.A. Marketing authorisation application 02/03/2021 1

N02AA05 oxycodone Oxycodone hydrochloride


N02AB03 fentanyl Fentanyl citrate



15



N02AJ Opioids in combination with non-opioid analgesics Paracetamol, Codeine phosphate hemihydrate, Caffeine


N02AJ06 codeine and paracetamol Paracetamol, Codeine phosphate hemihydrate


N02AJ13 tramadol and paracetamol Tramadol hydrochloride, Paracetamol


N02BE01 paracetamol Paracetamol

Baxter Holding B.V. Marketing authorisation application 02/12/2019 1Baxter Holding B.V. Marketing authorisation application 01/04/2020 1Teva B.V. Marketing authorisation application 27/08/2020 2Vitabalans Oy Marketing authorisation application 31/03/2021 1

N02BE51 paracetamol, combinations excl. psycholeptics Paracetamol, Codeine phosphate hemihydrate


N02BE51 paracetamol, combinations excl. psycholeptics Paracetamol, Ibuprofen sodium dihydrate

Vale Pharmaceuticals Limited Marketing authorisation application 03/08/2020 1

N02CC Selective 5HT1-receptor agonists Sumatriptan succinate, Naproxen sodium

Orion Corporation Orion Pharma Marketing authorisation application 31/12/2020 1

N02CC01 sumatriptan Sumatriptan succinate

C4 Health GmbH Marketing authorisation application 22/05/2020 1Paranova Oy Parallel import 31/07/2020 1

N03AE01 clonazepam Clonazepam

Vital Pharma Nordic ApS Marketing authorisation application 30/11/2020 1

N03AX14 levetiracetam Levetiracetam

PharOS - Pharmaceutical Oriented Services Ltd Marketing authorisation application 26/02/2021 4

N03AX18 lacosamide Lacosamide

Fresenius Kabi AB Marketing authorisation application 04/12/2020 1

N04BA02 levodopa and decarboxylase inhibitor Carbidopa monohydrate, Levodopa

Fair-Med Healthcare GmbH Marketing authorisation application 31/10/2019 4

N04BA02 levodopa and decarboxylase inhibitor Levodopa, Benserazide hydrochloride

Owlpharma Consulting LDA Marketing authorisation application 19/10/2020 1

N04BC07 apomorphine Apomorphine hydrochloride hemihydrate



16



N05AA03 promazine Promazine hydrochloride

Syri Pharma Limited Marketing authorisation application 26/10/2020 1

N05AH02 clozapine Clozapine


N05AX13 paliperidone Paliperidone palmitate

Amdipharm Limited Marketing authorisation application 29/07/2019 5Teva B.V. Marketing authorisation application 11/12/2020 6

N05BA09 clobazam Clobazam

Ethypharm Marketing authorisation application 16/12/2019 2Essential Pharmaceuticals Limited Marketing authorisation application 20/12/2019 1

N05CD08 midazolam Midazolam hydrochloride

Medir B.V. Marketing authorisation application 30/01/2020 3

N05CD08 midazolam Midazolam maleate

Veriton Pharma Limited Marketing authorisation application 02/11/2020 3

N05CH01 melatonin Melatonin

Bluefish Pharmaceuticals AB Marketing authorisation application 24/09/2020 12Care4 Generics ApS Marketing authorisation application 09/12/2020 1Neuraxpharm Arzneimittel GmbH u. Co. KG Marketing authorisation application 26/03/2021 1Orion Corporation Marketing authorisation application 15/04/2021 4

N05CM18 dexmedetomidine Dexmedetomidine hydrochloride

Baxter Holding B.V. Marketing authorisation application 02/12/2019 1Fresenius Kabi Ab Marketing authorisation application 16/10/2020 1

N06AX12 bupropion Bupropion hydrochloride


N06AX16 venlafaxine Venlafaxine hydrochloride

Paranova Oy Parallel import 09/03/2020 1Orion Corporation Marketing authorisation application 22/12/2020 1

N06AX21 duloxetine Duloxetine hydrochloride


N06BA04 methylphenidate Methylphenidate hydrochloride

Laboratorios Liconsa S.A. Marketing authorisation application 01/11/2018 4

N07BA03 varenicline Varenicline citrate, Varenicline citrate

Orion Corporation Marketing authorisation application 31/08/2020 3


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N07BA03 varenicline Varenicline citrate

Alfred E. Tiefenbacher (GmbH & Co. KG) Marketing authorisation application 11/09/2019 3Mylan AB Marketing authorisation application 31/07/2020 3Sandoz A/S Marketing authorisation application 31/07/2020 3Orion Corporation Marketing authorisation application 31/08/2020 3

N07BA03 varenicline Varenicline tartrate, Varenicline tartrate

STADA Arzneimittel AG Marketing authorisation application 29/05/2020 3

N07BA03 varenicline Varenicline tartrate

STADA Arzneimittel AG Marketing authorisation application 29/05/2020 3Reddy Holding GmbH Marketing authorisation application 30/03/2021 3

N07XX02 riluzole Riluzole

Italfarmaco SA Marketing authorisation application 15/03/2021 1

N07XX07 fampridine Fampridine

Medical Valley Invest AB Marketing authorisation application 26/07/2019 4STADA Arzneimittel AG Marketing authorisation application 02/08/2019 1Zentiva, k.s. Marketing authorisation application 05/03/2020 1

P02CF01 ivermectin Ivermectin

Pierre Fabre Dermatologie Marketing authorisation application 18/01/2016 1Medical Valley Invest AB Marketing authorisation application 26/03/2021 1

P03AC04 permethrin Permethrin

Morningside Healthcare (Malta) Limited Marketing authorisation application 24/02/2020 1Infectopharm Arzneimittel und Consilium GmbH Marketing authorisation application 02/11/2020 1

QA02BA02 ranitidine Ranitidine hydrochloride

Ecuphar NV Marketing authorisation application 12/11/2018 1Ceva Santé Animale Marketing authorisation application 29/01/2019 1

QA02BC01 omeprazole Omeprazole

Chanelle Pharmaceuticals Manufacturing Ltd Marketing authorisation application 16/10/2020 1

QA03FA01 metoclopramide Metoclopramide hydrochloride

Dechra Regulatory B.V. Marketing authorisation application 08/06/2020 2

QA12AX Calcium, combinations with vitamin D and/or other drugs Calcium gluconate, Magnesium chloride hexahydrate, Boric acid

Bela-Pharm GmbH & Co. KG Marketing authorisation application 11/09/2020 1

QA12AX Calcium, combinations with vitamin D and/or other drugs Calcium gluconate, Magnesium chloride hexahydrate

Alfasan Nederland BV Marketing authorisation application 29/10/2020 2


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QA12CX99 Other mineral products, combinations Butafosfan, Cyanocobalamin

Interchemie Eesti Werken De Adelaar Eesti AS Marketing authorisation application 19/11/2020 1CP-Pharma Handelsgesellschaft mbH Marketing authorisation application 11/03/2021 1Veyx-Pharma GmbH Marketing authorisation application 11/03/2021 1

QA12CX99 Other mineral products, combinations ZINC OXIDE, Manganese carbonate, Sodium selenite, Copper (II) carbonate

Warburton Technology Limited Marketing authorisation application 06/08/2020 1

QA14AB01 nandrolone Nandrolone

Le Vet Beheer B.V. Marketing authorisation application 13/01/2016 1

QC08CA01 amlodipine Amlodipine besylate


QD01AC52 miconazole, combinations Miconazole nitrate, Prednisolone acetate, Polymyxin b sulfate


QG02AD90 cloprostenol Cloprostenol sodium

Ceva Santé Animale Marketing authorisation application 15/12/2020 1

QH02AB02 dexamethasone Dexamethasone isonicotinate

Emdoka bvba Marketing authorisation application 16/04/2020 1

QH02AB02 dexamethasone Dexamethasone sodium phosphate

Curados B.V. Marketing authorisation application 20/07/2020 1

QH02AB02 dexamethasone Dexamethasone


QH02CA01 trilostane Trilostane


QI02AB01 Clostridium vaccine Clostridium perfringens Type A alpha toxoid, Clostridium perfringens beta toxoid, type B, Clostridium perfringens beta toxoid, type C, Clostridium perfringens epsilon toxoid, type D, Clostridium chavoei bacterium (inactivated) and toxoid, Clostridium novyi toxoid, Clostridium septicum toxoid, Clostridium tetani toxoid, Clostridium sordellii toxoid, Clostridium haemolyticum toxoid

Intervet International B.V. Marketing authorisation application 26/08/2020 1

QI07AB03 Bordetella vaccine Bordetella bronchiseptica fimbriae


QI09AA07 Porcine circovirus vaccine Porcine circovirus, inactivated type 2b, strain Rm

CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Marketing authorisation application 11/09/2015 1

QI09AB18 lawsonia Lawsonia intracellularis, strain SPAH-08, inactivated


QJ01CA04 amoxicillin Amoxicillin trihydrate

Univet Ltd. Marketing authorisation application 27/03/2018 1


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QJ01CE09 procaine penicillin Procaine benzylpenicillin

Bimeda Animal Health Limited Marketing authorisation application 06/04/2020 1

QJ01CR02 amoxicillin and enzyme inhibitor Amoxicillin trihydrate, Potassium clavulanate

Vetoquinol SA Marketing authorisation application 24/11/2020 1

QJ01FA90 tylosin Tylosin

Ceva Santé Animale Marketing authorisation application 04/12/2017 1

QJ51DB01 cefalexin Cefalexin benzathine

Virbac S.A. Marketing authorisation application 26/01/2021 1

QM01AC06 meloxicam Meloxicam

Provivo Oy Marketing authorisation application 25/03/2021 3

QM01AE03 ketoprofen Ketoprofen

Kela N.V. Marketing authorisation application 04/03/2020 1

QM01AG02 tolfenamic acid Tolfenamic acid

Vetoquinol SA Marketing authorisation application 23/03/2021 1

QM01AH90 firocoxib Firocoxib

LIVISTO Int'l, S.L. Marketing authorisation application 19/12/2019 2

QN01AX03 ketamine Ketamine hydrochloride

Alfasan Nederland BV Marketing authorisation application 14/01/2021 1

QN02AX02 tramadol Tramadol hydrochloride

Laboratoire TVM Marketing authorisation application 12/10/2020 1

QN04BC07 Apomorphine Apomorphine hydrochloride hemihydrate

Le Vet Beheer B.V. Marketing authorisation application 04/07/2018 1Dechra Regulatory B.V. Marketing authorisation application 25/11/2019 1

QN05AA04 acepromazine Acepromazine maleate


QN05BA01 diazepam Diazepam


QP53AC54 Permethrin, combinations Permethrin, Imidacloprid

KRKA, d.d., Novo mesto Marketing authorisation application 19/02/2021 4

QP54AA04 eprinomectin Eprinomectin


QP54AB02 moxidectin Moxidectine



20



QP54AB51 milbemycin oxime, combinations Milbemycin oxime, Praziquantel

Chanelle Pharmaceuticals Manufacturing Limited Marketing authorisation application 27/10/2017 1KRKA, d.d., Novo mesto Marketing authorisation application 25/09/2020 2Alfasan Nederland BV Marketing authorisation application 09/02/2021 6

QR05CB02 bromhexine Bromhexine hydrochloride

Dopharma Research B.V. Marketing authorisation application 13/04/2021 1

QS01XA08 acetylcysteine Acetylcysteine


QS01XA18 ciclosporin Ciclosporin


R01AD59 mometasone, combinations Olopatadine hydrochloride, Mometasone furoate monohydrate

Glenmark Pharmaceuticals s.r.o. Marketing authorisation application 02/01/2020 1

R02AD01 benzocaine Benzocaine

McNeil, a division of Janssen- Cilag Oy Marketing authorisation application 25/02/2019 1McNeil, a division of Janssen- Cilag Oy Marketing authorisation application 03/02/2020 1

R02AX01 flurbiprofen Flurbiprofen

Reckitt Benckiser Healthcare (Scandinavia) A/S Marketing authorisation application 25/01/2019 2Teva B.V. Marketing authorisation application 19/01/2021 1

R03AC02 salbutamol Salbutamol sulfate, Salbutamol

Neutec Inhaler Ireland Limited Marketing authorisation application 13/10/2020 1

R03AK06 salmeterol and fluticasone Salmeterol xinafoate, Fluticasone propionate

Respirent Pharmaceuticals B.V. Marketing authorisation application 11/02/2019 3Orifarm Generics A/S Marketing authorisation application 01/04/2021 3

R03AK08 formoterol and beclometasone Beclometasone dipropionate, Formoterol fumarate dihydrate

Mylan AB Marketing authorisation application 02/11/2020 2

R03AL02 salbutamol and ipratropium bromide Ipratropium bromide monohydrate, Salbutamol sulfate

Neutec Inhaler Ireland Limited Marketing authorisation application 30/11/2020 1

R03BA05 fluticasone Fluticasone propionate


R03BB04 tiotropium bromide Tiotropium bromide monohydrate


R05DB27 levodropropizine Levodropropizine



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R06AE05 meclozine Meclozine hydrochloride


R06AX13 loratadine Loratadine


R06AX27 desloratadine Desloratadine

Orion Corporation Orion Pharma Marketing authorisation application 23/12/2020 2

R06AX29 bilastine Bilastine

Menarini International Operations Luxembourg S.A. Marketing authorisation application 10/11/2020 1

R07AA02 natural phopholipids Poractant alfa


S01AX08 hexamidine Hexamidine diisethionate

Laboratoires Thea Marketing authorisation application 30/03/2021 1

S01AX18 povidone-iodine Povidone

Alfa Intes Industria Terapeutica Splendore S.r.l Marketing authorisation application 26/02/2021 1

S01BA01 dexamethasone Dexamethasone sodium phosphate

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories Marketing authorisation application 01/04/2021 1

S01BA04 prednisolone Prednisolone acetate


S01BA05 triamcinolone Triamcinolone acetonide


S01ED Beta blocking agents Bimatoprost, Timolol maleate

Pharmabide Ltd Marketing authorisation application 20/12/2019 1

S01ED Beta blocking agents Dorzolamide, Timolol maleate


S01ED51 timolol, combinations Dorzolamide, Timolol maleate


S01EE03 bimatoprost Bimatoprost


S01GX08 ketotifen Ketotifen hydrogen fumarate

Pharma Stulln GmbH Marketing authorisation application 03/12/2020 1

V03AB15 naloxone Naloxone hydrochloride dihydrate



22



V03AB35 sugammadex Sugammadex sodium

Noridem Enterprises Limited Marketing authorisation application 30/12/2020 1

V03AB35 sugammadex Sugammadex

Avansor Pharma Oy Marketing authorisation application 29/10/2019 1Hameln Pharma Plus GmbH Marketing authorisation application 29/10/2019 1

V03AC03 deferasirox Deferasirox

Glenmark Arzneimittel GmbH Marketing authorisation application 31/07/2020 3

V03AF01 mesna Mesna


V04CX06 hexaminolevulinate Hexaminolevulinate hydrochloridum

Orifarm Oy Parallel import 22/03/2021 12care4 ApS Parallel import 24/03/2021 1

V08AD01 ethyl esters of iodised fatty acids Ethiodized oil

Guerbet Marketing authorisation application 22/02/2021 1

V08CA02 gadoteric acid Gadoteric acid

Guerbet Marketing authorisation application 16/10/2020 1

V08CA10 gadoxetic acid Gadoxetate disodium


V09EB01 technetium (99mTc) macrosalb Human albumin macroaggregates

Medi-Radiopharma Ltd. Marketing authorisation application 04/01/2021 1

V09HA02 technetium (99mTc) exametazime labelled cells Exametazime

Radiopharmacy Laboratorium Kft. Marketing authorisation application 11/01/2021 1

V09IX09 gallium (68Ga) edotreotide PSMA-11

Advanced Nuclear Medicine Ingredients (ANMI) s.a. Marketing authorisation application 30/04/2020 1

pending marketing authorisation applications

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