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Pending marketing authorisation applications Situation 01/09/2021 12:53 1 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 A03AB02 glycopyrronium bromide Glycopyrronium bromide Clinigen Healthcare B.V. Marketing authorisation application 31/10/2019 1 EQL 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 Fresenius Kabi Ab Marketing authorisation application 11/12/2020 2 A05AA02 ursodeoxycholic acid Ursodeoxycholic acid PRO.MED.CS Praha a.s. Marketing authorisation application 31/08/2020 1 A06AD11 lactulose Lactulose liquid 66 % Creative Pharma Solutions s.r.o. Marketing authorisation application 03/06/2021 1 A07AA11 rifaximin Rifaximin Abacus Medicine A/S Parallel import 17/06/2021 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 Dr. Falk Pharma GmbH Marketing authorisation application 29/06/2021 1 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 A10BA02 metformin Metformin hydrochloride Accord Healthcare B.V. Marketing authorisation application 22/07/2019 2 Zentiva, k.s. Marketing authorisation application 04/05/2020 3 Accord Healthcare B.V. Marketing authorisation application 01/06/2020 3 Kappler Pharma Consult GmbH Marketing authorisation application 22/12/2020 3 Arriello s.r.o. Marketing authorisation application 23/12/2020 3 Sandoz A/S Marketing authorisation application 09/02/2021 3 Renantos Pharmavertriebsgesellschaft mbH Marketing authorisation application 04/05/2021 3 A10BD07 metformin and sitagliptin Metformin hydrochloride, Sitagliptin hydrochloride Teva B.V. Marketing authorisation application 31/03/2020 2

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Page 1: Pending marketing authorisation applications 1 Situation

Pending marketing authorisation applicationsSituation 01/09/2021 12:53

1

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

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

Fresenius Kabi Ab Marketing authorisation application 11/12/2020 2

A05AA02 ursodeoxycholic acid Ursodeoxycholic acid

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

A06AD11 lactulose Lactulose liquid 66 %

Creative Pharma Solutions s.r.o. Marketing authorisation application 03/06/2021 1

A07AA11 rifaximin Rifaximin

Abacus Medicine A/S Parallel import 17/06/2021 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 1Dr. Falk Pharma GmbH Marketing authorisation application 29/06/2021 1

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

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 3Renantos Pharmavertriebsgesellschaft mbH Marketing authorisation application 04/05/2021 3

A10BD07 metformin and sitagliptin Metformin hydrochloride, Sitagliptin hydrochloride

Teva B.V. Marketing authorisation application 31/03/2020 2

Page 2: Pending marketing authorisation applications 1 Situation

Pending marketing authorisation applicationsSituation 01/09/2021 12:53

2

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

A10BD07 metformin and sitagliptin Sitagliptin hydrochloride monohydrate, Metformin hydrochloride

Hexal 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 2Vivanta Generics s.r.o. Marketing authorisation application 02/08/2021 2

A10BH01 sitagliptin Sitagliptin hydrochloride monohydrate

STADA Arzneimittel AG Marketing authorisation application 02/08/2019 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

A10BK01 dapagliflozin Dapagliflozin

Teva B.V. Marketing authorisation application 17/11/2020 2

A11CC03 alfacalcidol Alfacalcidol

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

A11DA01 thiamine (vit B1) Thiamine hydrochloride

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

A12CA01 sodium chloride Sodium chloride

Abboxia AB Marketing authorisation application 16/08/2021 1

A16AX12 trientine Trientine dihydrochloride

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

Page 3: Pending marketing authorisation applications 1 Situation

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3

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

B01AB05 enoxaparin Enoxaparin sodium

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

B01AB09 danaparoid Danaparoid sodium

Paranova Oy Parallel import 01/03/2021 1

B01AC11 iloprost Iloprost trometamol

Zentiva, k.s. Marketing authorisation application 25/10/2019 2Pharmanovia A/S Marketing authorisation application 02/06/2021 2

B01AC21 treprostinil Treprostinil sodium

Reddy Holding GmbH Marketing authorisation application 30/09/2020 4

B01AC24 ticagrelor Ticagrelorum

Mylan AB Marketing authorisation application 05/03/2020 2Avansor Pharma Oy Marketing authorisation application 01/02/2021 2Vivanta Generics s.r.o. Marketing authorisation application 01/07/2021 2

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 3Galenicum Health S.L. Marketing authorisation application 28/05/2021 3

B01AF01 rivaroxaban Rivaroxaban

Hexal 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 5Egis Pharmaceuticals PLC Marketing authorisation application 01/07/2021 4Stada Arzneimittel AG Marketing authorisation application 30/07/2021 3

B01AF02 apixaban Apixaban

Stada Arzneimittel AG Marketing authorisation application 31/10/2019 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

Page 4: Pending marketing authorisation applications 1 Situation

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4

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

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

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

Fresenius Kabi Ab Marketing authorisation application 15/10/2020 1

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

Paranova Oy Parallel import 01/03/2021 1

B05ZB Hemofiltrates Trisodium citrate dihydrate

Fresenius Medical Care Deutschland GmbH Marketing authorisation application 31/03/2020 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 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 1Universal Farma S.L. Marketing authorisation application 14/04/2021 1

C01BB02 mexiletine Mexiletine hydrochloride

Macure Pharma ApS Marketing authorisation application 08/06/2021 3

C01BD01 amiodarone Amiodarone hydrochloride

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

C01CA03 norepinephrine Norepinephrine

Hameln Pharma Plus GmbH Marketing authorisation application 19/12/2019 1Laboratoire Aguettant Marketing authorisation application 09/06/2020 1

C01CA17 midodrine Midodrine hydrochloride

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

Page 5: Pending marketing authorisation applications 1 Situation

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5

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

C01CA26 ephedrine Ephedrine hydrochloride

2Care4 Generics ApS Marketing authorisation application 30/09/2020 1

C01CX08 levosimendan Levosimendan

Tillomed Pharma GmbH Marketing authorisation application 29/11/2019 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 1EQL Pharma AB Marketing authorisation application 30/06/2021 1

C01EA01 alprostadil Alprostadil

2care4 ApS Parallel import 19/03/2021 1

C02AC01 clonidine Clonidine hydrochloride

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

C02KX01 bosentan Bosentan monohydrate

Paranova Oy Parallel import 01/04/2021 1

C03DA04 eplerenone Eplerenone

Paranova Oy Parallel import 23/06/2020 2

C05BB02 polidocanol Lauromacrogolum 400

Paranova Oy Parallel import 23/02/2021 1Orifarm Oy Parallel import 01/03/2021 2

C07AB12 nebivolol Nebivolol hydrochloride

Accord Healthcare B.V. Marketing authorisation application 30/06/2020 1

C08CA05 nifedipine Nifedipine

Paranova Oy Parallel import 30/03/2021 1

C08CA13 lercanidipine Lercanidipine hydrochloride

Accord Healthcare B.V. Marketing authorisation application 27/08/2020 2

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

Stada Arzneimittel AG Marketing authorisation application 30/03/2020 4

D01AC01 clotrimazole Clotrimazole

Bayer Oy Marketing authorisation application 30/04/2020 1

Page 6: Pending marketing authorisation applications 1 Situation

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6

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

D01AC08 ketoconazole Ketoconazole

Paranova Oy Parallel import 28/01/2019 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

D11AX01 minoxidil Minoxidil

Ioulia And Irene Tsetis Pharmaceutical Laboratories S.A. Marketing authorisation application 12/07/2021 1

G02BB01 vaginal ring with progestogen and estrogen Etonogestrel, Ethinylestradiol

Abacus Medicine A/S Parallel import 17/08/2021 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

G03GA01 chorionic gonadotrophin Chorionic gonadotrophin

Laboratoires GENEVRIER Marketing authorisation application 30/10/2019 1

Page 7: Pending marketing authorisation applications 1 Situation

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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

G03GA02 human menopausal gonadotrophin Menotropine

IBSA Farmaceutici Italia S.r.l Marketing authorisation application 01/06/2021 1

G03HB01 cyproterone and estrogen Cyproterone acetate, Ethinylestradiol

Paranova Oy Parallel import 11/03/2021 1

G03XB01 mifepristone Mifepristone

Orifarm Oy Parallel import 30/03/2021 1

G04BD11 fesoterodine Fesoterodini fumarate

Accord Healthcare B.V. Marketing authorisation application 31/03/2020 1Accord Healthcare B.V. Marketing authorisation application 23/05/2021 1

G04BD12 mirabegron Mirabegron

Sandoz A/S Marketing authorisation application 25/01/2021 2

G04BE03 sildenafil Sildenafil citrate

Orion Corporation Marketing authorisation application 22/06/2020 2

G04BE08 tadalafil Tadalafil

Stada Arzneimittel AG Marketing authorisation application 22/03/2021 3

G04CA53 tamsulosin and solifenacin Solifenacin succinate, Tamsulosin

STADA Arzneimittel AG Marketing authorisation application 07/05/2021 1

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

Paranova Oy Parallel import 01/03/2021 1

H01BB03 carbetocin Carbetocin

Laboratoire Aguettant Marketing authorisation application 03/02/2021 1

H01CB03 lanreotide Lanreotide acetate

Paranova Oy Parallel import 10/11/2020 1

H01CC01 ganirelix Ganirelix acetate

Orifarm Generics A/S Marketing authorisation application 07/08/2020 1

H02AB02 dexamethasone Dexamethasone sodium phosphate

S.MED Pharmavertriebsgesellsch Marketing authorisation application 29/05/2019 1Akciju sabiedriba Kalceks Marketing authorisation application 16/11/2020 1Fresenius Kabi AB Marketing authorisation application 18/12/2020 1

Page 8: Pending marketing authorisation applications 1 Situation

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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

H02AB04 methylprednisolone Methylprednisolone sodium succinate

Orifarm Oy Parallel import 09/07/2020 1

H02AB09 hydrocortisone Hydrocortisone sodium succinate

Paranova Oy Parallel import 29/04/2021 1

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

Paranova Oy Parallel import 03/11/2020 1

J01AA12 tigecycline Tigecycline

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

J01CE01 benzylpenicillin Benzylpenicillin potassium

"Polfa" Tarchomin SA Marketing authorisation application 29/07/2021 1

J01CE08 benzylpenicillin, benzathine Benzathine benzylpenicillin

Macure Pharma ApS Marketing authorisation application 17/07/2018 2

J01CF02 cloxacillin Cloxacillin sodium

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

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

Macure Pharma ApS Marketing authorisation application 29/05/2020 1

J01CR05 piperacillin and beta-lactamase inhibitor Piperacillin sodium, Tazobactam sodium

Qilu Pharma Spain S.L. Marketing authorisation application 13/05/2021 2

J01DB01 cefalexin Cefalexin monohydrate

Antibiotice SA Marketing authorisation application 23/06/2020 1

J01DD04 ceftriaxone Ceftriaxone sodium

AS KALCEKS Marketing authorisation application 20/08/2021 2

Page 9: Pending marketing authorisation applications 1 Situation

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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

J01DH02 meropenem Meropenem trihydrate

Tenshi 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 1Akciju sabiedriba Kalceks Marketing authorisation application 23/06/2021 2

J01FA10 azithromycin Azithromycin

Macure Pharma ApS Marketing authorisation application 17/03/2021 1

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

Paranova Oy Parallel import 08/03/2021 1

J01XX05 methenamine Methenamine hippurate

Orion Corporation Orion Pharma Marketing authorisation application 27/08/2021 1

J01XX09 daptomycin Daptomycin

Hameln Pharma GmbH Marketing authorisation application 30/07/2021 2

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

J02AX04 caspofungin Caspofungin acetate

Tillomed Pharma GmbH Marketing authorisation application 03/05/2021 2

J02AX04 caspofungin Caspofungin

Tillomed Pharma GmbH Marketing authorisation application 03/05/2021 2

J05AB12 cidofovir Cidofovir dihydrate

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

J05AB14 valganciclovir Valganciclovir hydrochloride

Paranova Oy Parallel import 22/02/2021 12care4 ApS Parallel import 10/03/2021 1

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

Page 10: Pending marketing authorisation applications 1 Situation

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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

L01AA01 cyclophosphamide Cyclophosphamide monohydrate

Accord Healthcare B.V. Marketing authorisation application 28/02/2020 2

L01AA03 melphalan Melphalan hydrochloride

Accord Healthcare B.V. Marketing authorisation application 30/03/2021 1

L01AA06 ifosfamide Ifosfamide

Orifarm Oy Parallel import 01/03/2021 1

L01AA09 bendamustine Bendamustine hydrochloride

Accord Healthcare B.V. Marketing authorisation application 31/03/2020 1

L01AC01 thiotepa Thiotepa

Fresenius Kabi Ab Marketing authorisation application 18/12/2020 2

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

Orifarm Oy Parallel import 01/03/2021 1

L01BC07 azacitidine Azacitidine

Nordic 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

Page 11: Pending marketing authorisation applications 1 Situation

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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

L01CD04 cabazitaxel Cabazitaxel

Vivanta Generics s.r.o. Marketing authorisation application 29/03/2019 1Fresenius Kabi Ab Marketing authorisation application 26/03/2021 1Glenmark Arzneimittel GmbH Marketing authorisation application 04/05/2021 1

L01DB01 doxorubicin Doxorubicin hydrochloride

Teva B.V. Marketing authorisation application 03/09/2018 1

L01DB06 idarubicin Idarubicin hydrochloride

Orifarm Oy Parallel import 01/03/2021 1

L01DB07 mitoxantrone Mitoxantrone hydrochloride

Paranova Oy Parallel import 01/03/2021 1

L01EA02 dasatinib Dasatinib

STADA Arzneimittel AG Marketing authorisation application 30/06/2021 6

L01EG02 everolimus Everolimus

Ethypharm Marketing authorisation application 16/03/2021 3

L01EX01 sunitinib Sunitinib malate

Vivanta 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

Accord Healthcare B.V. Marketing authorisation application 26/03/2021 1

L01XG01 bortezomib Bortezomib

Baxter 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

L01XX02 asparaginase CRISANTASPASE

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

L02AE04 triptorelin Triptorelin embonate

Paranova Oy Parallel import 11/08/2021 1

L02BA03 fulvestrant Fulvestrant

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

L02BB04 enzalutamide Enzalutamide

Adalvo Limited Marketing authorisation application 01/07/2021 1

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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

L02BX03 abiraterone Abiraterone acetate

Avansor Pharma Oy Marketing authorisation application 09/09/2019 2Glenmark Arzneimittel GmbH Marketing authorisation application 09/09/2019 1TEVA Pharma B.V. Marketing authorisation application 01/12/2020 1Medical Valley Invest AB Marketing authorisation application 18/01/2021 1

L03AX16 plerixafor Plerixafor

Seacross Pharma (Europe) Limited Marketing authorisation application 09/08/2021 1

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

Pfizer Oy Marketing authorisation application 30/01/2020 1

L04AA18 everolimus Everolimus

Orifarm Oy Parallel import 01/03/2021 1

L04AA27 fingolimod Fingolimod hydrochloride

Bausch Health Ireland Limited Marketing authorisation application 25/10/2019 1Tillomed Pharma GmbH Marketing authorisation application 01/11/2019 1Sandoz A/S Marketing authorisation application 28/12/2020 1Neuraxpharm Sweden AB Marketing authorisation application 06/07/2021 1

L04AX04 lenalidomide Lenalidomide ammonium chloride

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

L04AX04 lenalidomide Lenalidomide

STADA 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 2Accord Healthcare B.V. Marketing authorisation application 10/05/2021 2Vivanta Generics s.r.o. Marketing authorisation application 31/05/2021 2

L04AX07 dimethyl fumarate Dimethyl fumarate

Eignapharma S.L. Marketing authorisation application 26/05/2021 2Sandoz A/S Marketing authorisation application 21/07/2021 2

M01AB15 ketorolac Ketorolac tromethamine

EQL Pharma AB Marketing authorisation application 22/07/2019 1

M01AE01 ibuprofen Ibuprofen lysine, Ibuprofen

Vitabalans Oy Marketing authorisation application 22/01/2021 1

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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

M01AE01 ibuprofen Ibuprofen lysine

Vitabalans Oy Marketing authorisation application 31/01/2018 1

M01AE01 ibuprofen Ibuprofen

Strides Pharma (Cyprus) Limited Marketing authorisation application 06/05/2020 4Fair-Med Healthcare GmbH Marketing authorisation application 07/05/2020 4Pharmaclan s.r.o. Marketing authorisation application 03/05/2021 4Reckitt Benckiser Healthcare (Scandinavia) A/S Marketing authorisation application 02/07/2021 1

M01AE02 naproxen Naproxen

Accord Healthcare B.V. Marketing authorisation application 01/10/2020 2

M01AX25 chondroitin sulfate Sodium chondroitin sulphate

Paranova Oy Parallel import 05/07/2021 1

M03AB01 suxamethonium Suxamethonium chloride

EQL Pharma AB Marketing authorisation application 25/01/2021 1

M03AC09 rocuronium bromide Rocuronium bromide

Accord Healthcare B.V. Marketing authorisation application 31/05/2021 1

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)

Paranova Oy Parallel import 06/04/2021 1

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

Abacus Medicine A/S Parallel import 26/11/2020 1

M03BX02 tizanidine Tizanidine

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

M05BA04 alendronic acid Sodium alendronate trihydrate

Accord Healthcare B.V. Marketing authorisation application 25/11/2020 1

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

N01AH01 fentanyl Fentanyl citrate

Laboratórios Basi Indústria Farmacêutica S.A. Marketing authorisation application 30/07/2021 1

N01AH06 remifentanil Remifentanil hydrochloride

hameln pharma gmbh Marketing authorisation application 30/06/2021 3

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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

N01BB03 mepivacaine Mepivacaine hydrochloride

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

N02AA05 oxycodone Oxycodone hydrochloride

Orifarm Generics A/S Marketing authorisation application 29/01/2021 2Abboxia AB Marketing authorisation application 17/05/2021 2

N02AB03 fentanyl Fentanyl citrate

Sandoz A/S Marketing authorisation application 02/03/2020 6

N02AE01 buprenorphine Buprenorphine

Sandoz A/S Marketing authorisation application 30/04/2021 2

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

Accord Healthcare B.V. Marketing authorisation application 24/07/2019 1

N02AJ06 codeine and paracetamol Paracetamol, Codeine phosphate hemihydrate

Accord Healthcare B.V. Marketing authorisation application 02/03/2020 1

N02AJ13 tramadol and paracetamol Tramadol hydrochloride, Paracetamol

Accord Healthcare B.V. Marketing authorisation application 31/03/2020 1

N02BE01 paracetamol Paracetamol

Baxter 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

Accord Healthcare B.V. Marketing authorisation application 01/10/2018 1

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 1

N03AE01 clonazepam Clonazepam

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

N03AX12 gabapentin Gabapentin

Strides Pharma (Cyprus) Limited Marketing authorisation application 07/07/2021 3

N03AX14 levetiracetam Levetiracetam

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

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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

N03AX18 lacosamide Lacosamide

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

N04BA Dopa and dopa derivatives Foslevodopa, Levodopa, Foscarbidopa, Carbidopa

AbbVie Oy Marketing authorisation application 02/08/2021 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

N05AA03 promazine Promazine hydrochloride

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

N05AH02 clozapine Clozapine

Paranova Oy Parallel import 03/10/2018 1

N05AX13 paliperidone Paliperidone palmitate

Amdipharm Limited Marketing authorisation application 29/07/2019 5ratiopharm GmbH Marketing authorisation application 11/12/2020 6

N05BA Benzodiazepine derivatives Clobazam

Ethypharm Marketing authorisation application 16/12/2019 2

N05BA09 clobazam Clobazam

Essential 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 4Teva B.V. Marketing authorisation application 11/05/2021 1

N05CM18 dexmedetomidine Dexmedetomidine hydrochloride

Fresenius Kabi Ab Marketing authorisation application 16/10/2020 1EVER Valinject GmbH Marketing authorisation application 01/07/2021 1

Page 16: Pending marketing authorisation applications 1 Situation

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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

N06AX12 bupropion Bupropion hydrochloride

Paranova Oy Parallel import 15/01/2019 1Accord Healthcare B.V. Marketing authorisation application 01/06/2021 1Sandoz A/S Marketing authorisation application 02/07/2021 1

N06AX16 venlafaxine Venlafaxine hydrochloride

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

N06AX21 duloxetine Duloxetine hydrochloride

Accord Healthcare B.V. Marketing authorisation application 27/12/2018 2Paranova Oy Parallel import 09/06/2021 1

N06BA04 methylphenidate Methylphenidate hydrochloride

Laboratorios Liconsa S.A. Marketing authorisation application 01/11/2018 4Orifarm Oy Parallel import 16/06/2021 4

N07AA51 neostigmine, combinations Glycopyrronium bromide, Neostigmine metilsulfate

EQL Pharma AB Marketing authorisation application 03/05/2021 1

N07BA03 varenicline Varenicline citrate, Varenicline citrate

Orion Corporation Marketing authorisation application 31/08/2020 3

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

P01AB01 metronidazole Metronidazole

DiaMed Beratungsgesellschaft für pharmaz. Unternehmen mbH Marketing authorisation application 26/07/2021 2

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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

P02CF01 ivermectin Ivermectin

Medical Valley Invest AB Marketing authorisation application 26/03/2021 1

P03AC04 permethrin Permethrin

Infectopharm 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

QA12CX99 Other mineral products, combinations Butafosfan, Cyanocobalamin

CP-Pharma Handelsgesellschaft mbH Marketing authorisation application 11/03/2021 1Veyx-Pharma GmbH Marketing authorisation application 11/03/2021 1

QA14AB01 nandrolone Nandrolone

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

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

Chanelle Pharmaceuticals Manufacturing Ltd Marketing authorisation application 11/03/2021 1

QG02AD90 cloprostenol Cloprostenol sodium

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

QG04BX90 ephedrine Ephedrine hydrochloride

Richter Pharma AG Marketing authorisation application 20/07/2021 2

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

Le Vet Beheer B.V. Marketing authorisation application 14/12/2016 2

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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

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

QI02AL01 inactivated Bovine rotavirus vaccine + inactivated Bovine coronavirus vaccine + inactivated Escherichia Escherichia coli F5 (K99) adhesin, Inactivated bovine rotavirus, strain TM-91 , Inactivated Bovine Coronavirus, strain C-197

Boehringer Ingelheim Vetmedica GmbH Marketing authorisation application 26/05/2021 1

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

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

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

QN01AB08 sevoflurane Sevoflurane

Piramal Critical Care B.V. Marketing authorisation application 09/08/2021 1

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 1

QN05AA04 acepromazine Acepromazine maleate

Le Vet Beheer B.V. Marketing authorisation application 13/10/2016 1

QN05BA01 diazepam Diazepam

Le Vet Beheer B.V. Marketing authorisation application 24/10/2017 1

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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

QN05CM92 xylazine Xylazine hydrochloride

Alfasan Nederland BV Marketing authorisation application 07/06/2021 1

QP53AC11 deltamethrin Deltamethrin

Vetpharma Animal Health, S.L. Marketing authorisation application 04/06/2021 3

QP53AC54 Permethrin, combinations Permethrin, Imidacloprid

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

QP54AA04 eprinomectin Eprinomectin

Chanelle Pharmaceuticals Manufacturing Ltd Marketing authorisation application 07/07/2015 1

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

QS01XA18 ciclosporin Ciclosporin

Laboratoire TVM Marketing authorisation application 04/12/2020 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 2

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

Paranova Oy Parallel import 25/01/2021 1Abacus Medicine A/S Parallel import 11/05/2021 1Abacus Medicine A/S Parallel import 03/06/2021 1

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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

R03BB04 tiotropium bromide Tiotropium bromide monohydrate

Paranova Oy Parallel import 13/04/2021 1LUPIN EUROPE GMBH Marketing authorisation application 12/05/2021 1Abacus Medicine A/S Parallel import 24/08/2021 1

R05CB06 ambroxol Ambroxol hydrochloride

Teva B.V. Marketing authorisation application 29/04/2021 1

R05DB27 levodropropizine Levodropropizine

Teva B.V. Marketing authorisation application 23/12/2020 1

R06AE05 meclozine Meclozine hydrochloride

Orifarm Oy Parallel import 08/07/2021 1

R06AX13 loratadine Loratadine

Accord Healthcare B.V. Marketing authorisation application 01/06/2020 1

R06AX29 bilastine Bilastine

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

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

S01BA05 triamcinolone Triamcinolone acetonide

Orifarm Oy Parallel import 01/03/2021 1

S01EC03 dorzolamide Dorzolamide hydrochloride

Vale Pharmaceuticals Limited Marketing authorisation application 21/05/2021 1

S01ED Beta blocking agents Bimatoprost, Timolol maleate

Pharmabide Ltd Marketing authorisation application 20/12/2019 1

S01ED Beta blocking agents Dorzolamide, Timolol maleate

Pharmabide Ltd Marketing authorisation application 27/06/2019 1

S01ED51 timolol, combinations Bimatoprost, Timololi hemihydrate, Timolol maleate

Vale Pharmaceuticals Limited Marketing authorisation application 26/05/2021 1

S01ED51 timolol, combinations Dorzolamide hydrochloride, Timolol maleate

Vale Pharmaceuticals Limited Marketing authorisation application 21/05/2021 1

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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

S01EE03 bimatoprost Bimatoprost

Pharmabide Ltd Marketing authorisation application 19/12/2018 1Vale Pharmaceuticals Limited Marketing authorisation application 26/05/2021 1

S01EE05 tafluprost Tafluprost

Santen Oy Marketing authorisation application 18/05/2021 1

V03AB14 protamine Protamine sulfate

2care4 ApS Parallel import 13/07/2021 1

V03AB15 naloxone Naloxone hydrochloride dihydrate

Accord Healthcare B.V. Marketing authorisation application 31/03/2021 1

V03AB35 sugammadex Sugammadex sodium

Noridem Enterprises Limited Marketing authorisation application 30/12/2020 1Stada Arzneimittel AG Marketing authorisation application 28/05/2021 1Qilu Pharma Spain S.L. Marketing authorisation application 30/07/2021 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

Orifarm Oy Parallel import 01/03/2021 2

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

Orifarm Oy Parallel import 01/03/2021 1

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