Pending marketing authorisation applications
Transcript of 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
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
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
Teva B.V. Marketing authorisation application 31/03/2020 2
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
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
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
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
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
Paranova Oy Parallel import 01/03/2021 1
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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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
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
Fresenius Kabi Ab Marketing authorisation application 15/10/2020 1
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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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
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, 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
Paranova Oy Parallel import 01/03/2021 1
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
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
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
Paranova Oy Parallel import 16/03/2021 12care4 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 3
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
D01AC08 ketoconazole Ketoconazole
Paranova Oy Parallel import 28/01/2019 1
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
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
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
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
Paranova Oy Parallel import 11/03/2021 1
G03XB01 mifepristone Mifepristone
Orifarm Oy Parallel import 30/03/2021 1
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
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
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
Amdipharm Limited Marketing authorisation application 20/03/2019 3Paranova Oy Parallel import 10/11/2020 1
H01CC01 ganirelix Ganirelix acetate
Orifarm Generics A/S Marketing authorisation application 07/08/2020 1
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
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
Orifarm Oy Parallel import 04/12/2020 1
H02AB04 methylprednisolone Methylprednisolone sodium succinate
Orifarm Oy Parallel import 09/07/2020 2
H02AB04 methylprednisolone Methylprednisolone, Methylprednisolone sodium succinate
Orifarm Oy Parallel import 09/07/2020 2
H02AB08 triamcinolone Triamcinolone hexacetonide
2care4 ApS Parallel import 23/02/2021 1
H02AB09 hydrocortisone Hydrocortisone sodium succinate
Paranova Oy Parallel import 23/03/2021 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
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
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
J01CR02 amoxicillin and beta-lactamase inhibitor Amoxicillin sodium, Potassium clavulanate
Macure Pharma ApS Marketing authorisation application 29/05/2020 1
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
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
J02AA01 amphotericin Amphotericin b
Abacus Medicine A/S Parallel import 31/03/2021 1
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
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
L01AA01 cyclophosphamide Cyclophosphamide monohydrate
Accord Healthcare B.V. Marketing authorisation application 28/02/2020 2
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
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
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
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
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
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
L01EA01 imatinib Imatinib mesylate
Stada Arzneimittel AG Marketing authorisation application 26/07/2019 1
L01EA02 dasatinib Dasatinib
Paranova Oy Parallel import 13/04/2021 1
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
Accord Healthcare B.V. Marketing authorisation application 26/03/2021 1
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
Pending marketing authorisation applicationsSituation 17/05/2021 08:58
13
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
L02BA03 fulvestrant Fulvestrant
Reddy Holding GmbH Marketing authorisation application 17/09/2020 1Paranova Oy Parallel import 07/04/2021 1
L02BG06 exemestane Exemestane
Paranova Oy Parallel import 22/01/2021 1
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
Orifarm Oy Parallel import 01/03/2021 2
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
EQL PHARMA AB Marketing authorisation application 22/07/2019 1
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
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
Accord Healthcare B.V. Marketing authorisation application 01/10/2020 2
M03AB01 suxamethonium Suxamethonium chloride
EQL PHARMA AB Marketing authorisation application 25/01/2021 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
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 2
N02AB03 fentanyl Fentanyl citrate
Sandoz A/S Marketing authorisation application 02/03/2020 6
Pending marketing authorisation applicationsSituation 17/05/2021 08:58
15
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
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 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
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 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
Paranova Oy Parallel import 08/09/2020 1
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
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 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
Paranova Oy Parallel import 15/01/2019 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 2
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
Pending marketing authorisation applicationsSituation 17/05/2021 08:58
17
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
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
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
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
Dechra Regulatory B.V. Marketing authorisation application 23/08/2019 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
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
QH02CA01 trilostane Trilostane
Dechra Regulatory B.V. Marketing authorisation application 05/12/2019 1
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
Intervet International B.V. Marketing authorisation application 09/07/2019 2
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
Intervet International B.V. Marketing authorisation application 30/10/2019 1
QJ01CA04 amoxicillin Amoxicillin trihydrate
Univet Ltd. Marketing authorisation application 27/03/2018 1
Pending marketing authorisation applicationsSituation 17/05/2021 08:58
19
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
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
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
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
QP54AB02 moxidectin Moxidectine
Chanelle Pharmaceuticals Manufacturing Ltd Marketing authorisation application 09/07/2020 1
Pending marketing authorisation applicationsSituation 17/05/2021 08:58
20
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
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
Laboratoire TVM Marketing authorisation application 09/07/2020 1
QS01XA18 ciclosporin Ciclosporin
Laboratoire TVM Marketing authorisation application 04/12/2020 1
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
Paranova Oy Parallel import 25/01/2021 1
R03BB04 tiotropium bromide Tiotropium bromide monohydrate
Paranova Oy Parallel import 13/04/2021 1
R05DB27 levodropropizine Levodropropizine
Teva B.V. Marketing authorisation application 23/12/2020 1
Pending marketing authorisation applicationsSituation 17/05/2021 08:58
21
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
R06AE05 meclozine Meclozine hydrochloride
Paranova Oy Parallel import 12/01/2021 1
R06AX13 loratadine Loratadine
Accord Healthcare B.V. Marketing authorisation application 01/06/2020 1
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
Paranova Oy Parallel import 01/03/2021 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
S01BA04 prednisolone Prednisolone acetate
Abacus Medicine A/S Parallel import 04/12/2020 1
S01BA05 triamcinolone Triamcinolone acetonide
Orifarm Oy Parallel import 01/03/2021 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 Dorzolamide, Timolol maleate
Orifarm Oy Parallel import 15/12/2020 1
S01EE03 bimatoprost Bimatoprost
Pharmabide Ltd Marketing authorisation application 19/12/2018 1
S01GX08 ketotifen Ketotifen hydrogen fumarate
Pharma Stulln GmbH Marketing authorisation application 03/12/2020 1
V03AB15 naloxone Naloxone hydrochloride dihydrate
Accord Healthcare B.V. Marketing authorisation application 31/03/2021 1
Pending marketing authorisation applicationsSituation 17/05/2021 08:58
22
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
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
Orifarm Oy Parallel import 01/03/2021 2
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
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