Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2019 to 30 June 2019 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2019-07-26
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2019252EN.01001501.xml










26.7.2019   


EN


Official Journal of the European Union


C 252/15






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2019 to 30 June 2019

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2019/C 252/02)






—



Issuing, maintenance or modification of a national marketing authorisation















Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




6.6.2019


Omega-3 acid ethyl esters


omega-3 acid ethyl esters


See Annex


See Annex


7.6.2019






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX

List of medicinal products and presentations











Member State in EEA


Marketing authorisaton holder


Product name


INN + Strength


Pharmaceutical form


Route of administration




Austria


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Austria


Pronova Biopharma Norge As


Zodin


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Belgium


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Belgium


Ibsa Farmaceutici Italia


Trimacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Bulgaria


Pronova Biopharma Norge As


Омакор


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Croatia


Pliva Hrvatska D.O.O.


Corprotect


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Croatia


Mylan Hrvatska D.O.O.


Dualtis


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Croatia


Mylan Hrvatska D.O.O.


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Cyprus


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Denmark


Strides Arcolab International Limited


Megazza Strides


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Estonia


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




France


Eg Labo Laboratoires Eurogenerics


Esters Ethyliques D’acides Omega 3 Eg Labo Conseil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




France


Laboratoires Genevrier


Esters Ethyliques D’acides Omega-3 Genevrier


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




France


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




France


Pronova Biopharma Norge As


Zodin


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Glenmark Pharmaceuticals Europe Limited


Omega 3


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Biomo Pharma Gmbh


Omega-3


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Ntc Srl


Omega-3 Ntc


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Ratiopharm Gmbh


Omega-3 Ratiopharm


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Heumann Pharma Gmbh & Co. Generica Kg


Omega-3-Säurenethylester 90 Heumann


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Ibsa Farmaceutici Italia


Omegoil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Germany


Pronova Biopharma Norge As


Zodin Omega-3


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Greece


Bennett Pharmaceuticals Sa


Becolip


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Greece


Zwitter Pharmaceuticals Επε


Dynapen-3


Fish Oil 1000 mg Capsule


Capsule, Soft


Oral Use




Greece


Pharmanel Commercial Pharmaceutical S.A.


Eicodol


Eicosapentaenoic Acid Ethyl Ester 460 mg Capsule, Docosahexaenoic Acid Ethyl Ester 380 mg Capsule


Capsule, Soft


Oral Use




Greece


Heremco


Emfrastop


Docosahexaenoic Acid 527 mg/5 ml, Eicosapentaenoic Acid 791 mg/5 ml


Oral Solution


Oral Use




Greece


Alapis Abee


Epadoc


Docosahexaenoic Acid 527 mg/5 ml, Vitamin D 10 I.U.G, Eicosapentaenoic Acid 791 mg/5 ml, Vitamin A 100 I.U.G


Oral Solution


Oral Use




Greece


Mediapharm Ltd


Farlipid


Docosahexaenoic Acid 115 mg Capsule, Vitamin D 1 I.U.G, Eicosapentaenoic Acid 170 mg Capsule, Vitamin A 1 I.U.G


Capsule, Soft


Oral Use




Greece


Mediapharm Ltd


Farlipid


Docosahexaenoic Acid 265 mg/5 ml, Eicosapentaenoic Acid 390 mg/5 ml


Oral Emulsion


Oral Use




Greece


Mediapharm Ltd


Farlipid


Docosahexaenoic Acid 527 mg/5 ml, Eicosapentaenoic Acid 791 mg/5 ml


Oral Solution


Oral Use




Greece


Naturalia S.A.


Hemido


Eicosapentaenoic Acid Ethyl Ester 460 mg Capsule, Docosahexaenoic Acid Ethyl Ester 380 mg Capsule


Capsule, Soft


Oral Use




Greece


Verisfield (Uk) Ltd


Lipemia


Docosahexaenoic Acid 115 mg Capsule, Eicosapentaenoic Acid 170 mg Capsule


Capsule, Soft


Oral Use




Greece


Verisfield (Uk) Ltd


Lipemia


Fish Oil 0,5 ml/ml


Oral Emulsion


Oral Use




Greece


Verisfield (Uk) Ltd


Lipemia Forte


Omega-3-Acid Ethyl Esters 1000 mg Capsule


Capsule, Soft


Oral Use




Greece


Rafarm Sa.


Loitrol


Docosahexaenoic Acid 115 mgg, Eicosapentaenoic Acid 170 μgg


Oral Solution


Oral Use




Greece


Trygg Pharma As


Lypiad


Eicosapentaenoic Acid Ethyl Ester 460 mg Capsule, Docosahexaenoic Acid Ethyl Ester 380 mg Capsule


Capsule, Soft


Oral Use




Greece


Pharmanel Commercial Pharmaceutical S.A.


Macoil


Omega-3-Acid Ethyl Esters 1000 mg Capsule


Capsule, Soft


Oral Use




Greece


Cana S.A. Farmakeftika Ergastiria


Maxepa


Docosahexaenoic Acid 115 mg Capsule, Vitamin D 10 I.U.G, Eicosapentaenoic Acid 170 mg Capsule, Vitamin A 100 I.U.G


Capsule, Soft


Oral Use




Greece


Cana S.A. Farmakeftika Ergastiria


Maxepa


Docosahexaenoic Acid 527 mg/5 ml, Vitamin D 10 I.U.G, Eicosapentaenoic Acid 791 mg/5 ml, Vitamin A 100 I.U.G


Oral Solution


Oral Use




Greece


Bgp Products Ltd (Greece)


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Greece


Trygg Pharma As


Omega-3-Acid-Ethyl-Ester/Lomegar


Eicosapentaenoic Acid Ethyl Ester 460 mg Capsule, Docosahexaenoic Acid Ethyl Ester 380 mg Capsule


Capsule, Soft


Oral Use




Greece


Novendia Pharmaceuticals Ltd


Pazeril


Docosahexaenoic Acid 115 mg Capsule, Eicosapentanoic Acid/Docosahexaenoic Acid 170 mg Capsule


Capsule, Soft


Oral Use




Greece


Novendia Pharmaceuticals Ltd


Pazeril


Docosahexaenoic Acid 527 mg/5 ml,Eicosapentanoic Acid/Docosahexaenoic Acid 791 mg/5 ml


Oral Solution


Oral Use




Greece


Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.


Prolipid


Docosahexaenoic Acid 120 mg Capsule, Eicosapentaenoic Acid 180 mg Capsule


Capsule, Soft


Oral Use




Greece


Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.


Prolipid


Docosahexaenoic Acid 60 mg Capsule, Eicosapentaenoic Acid 90 mg Capsule


Capsule, Soft


Oral Use




Greece


Pharmanel Commercial Pharmaceutical S.A.


Sea-Oil


Eicosapentaenoic Acid Ethyl Ester 460 mg Capsule, Docosahexaenoic Acid Ethyl Ester 380 mg Capsule


Capsule, Soft


Oral Use




Greece


Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.


Tropolipid


Eicosapentaenoic Acid Ethyl Ester 430 mg Capsule, Docosahexaenoic Acid Ethyl Ester 437 mg Capsule


Capsule, Soft


Oral Use




Greece


Ferrer-Galenica S.A.


Zodin


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Hungary


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Hungary


Ibsa Pharma Kft


Panoil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Ireland


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Ireland


Clonmel Healthcare Ltd


Trimega


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


I.B.N. Savio S.R.L.


Agemo


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Pfizer Italia S.R.L.


Esapent


Esters Of Unsaturated Fatty Acids 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Pfizer Italia S.R.L.


Esapent


Esters Of Unsaturated Fatty Acids 500 mg Capsule


Capsule, Soft


Oral Use




Italy


Alfasigma S.P.A.


Eskim


Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85 %. 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Alfasigma S.P.A.


Eskim


Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85 %. 500 mg Capsule


Capsule, Soft


Oral Use




Italy


Ibsa Farmaceutici Italia


Olevia


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Alfasigma S.P.A.


Omega 3 Alfasigma


Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85 %. 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


S.P.A. Italiana Laboratori Bouty


Omega 3 Bouty


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Doc Generici S.R.L.


Omega 3 Doc


Esters Of Unsaturated Fatty Acids 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Doc Generici S.R.L.


Omega 3 Doc Generici


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Eg S.P.A.


Omega 3 Eg


Esters Of Unsaturated Fatty Acids 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Strides Arcolab International Limited


Omega 3 Strides Arcolab International


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Teva Italia S.R.L.


Omega 3 Teva


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Altergon Italia S.R.L.


Omegoil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Spa – Società Prodotti Antibiotici S.P.A.


Seacor


Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85 %. 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Spa – Società Prodotti Antibiotici S.P.A.


Seacor


Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85 %. 500 mg Capsule


Capsule, Soft


Oral Use




Italy


Alfasigma S.P.A.


Trioreg


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Italy


Piam Farmaceutici S.P.A.


Triscudil


Eicosapentaenoic Acid Ethyl Ester 460 mg Capsule, Docosahexaenoic Acid Ethyl Ester 380 mg Capsule


Capsule, Soft


Oral Use




Latvia


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Lithuania


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Luxembourg


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Luxembourg


Ibsa Farmaceutici Italia


Omegoil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Malta


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Netherlands


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Netherlands


Teva Nederland B.V.


Omega-3 Vetzuren Ethylesters 90 Teva


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Netherlands


Ibsa Farmaceutici Italia


Omegoil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Norway


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Poland


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Portugal


Ntc Srl


Ésteres Etílicos 90 Do Ácido Omega-3 Ntc


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Portugal


Pharmanel Commercial Pharmaceutical S.A.


Ésteres Etílicos 90 Dos Ácidos Ómega-3 Pharmanel


Omega-3-Acid Ethyl Esters 1000 mg Capsule


Capsule, Soft


Oral Use




Portugal


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Portugal


Ibsa Farmaceutici Italia


Panoil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Portugal


Pronova Biopharma Norge As


Zodin


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Romania


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Romania


Pronova Biopharma Norge As


Omacor


Triglycerides Medium Chain 1qs Capsule, Lecithin Soya 1qs Capsule, Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Romania


Teva Pharmaceuticals S.R.L


Tevocor


Omega-3 Fatty Acids 1000 mg Capsule


Capsule, Soft


Oral Use




Romania


Ntc Srl


Vasoteran


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Slovenia


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Slovenia


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Spain


Aristo Pharma Iberia, S.L.


Ácidos Omega 3 Aristo


Omega-3-Acid Ethyl Esters 1000 mg Capsule


Capsule, Soft


Oral Use




Spain


Kern Pharma, S.L.


Ácidos Omega 3 Kern Pharma


Eicosapentaenoic Acid Ethyl Ester 460 mg Capsule, Docosahexaenoic Acid Ethyl Ester 380 mg Capsule


Capsule, Soft


Oral Use




Spain


Laboratorio Stada, S.L.


Acidos Omega 3 Stada


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Spain


Strides Arcolab International Limited


Ácidos Omega 3 Strides


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Spain


Tarbis Farma, S.L.


Ácidos Omega 3 Tarbis


Docosahexaenoic Acid 380 mg Capsule, Eicosapentaenoic Acid 460 mg Capsule, Omega-3-Acid Ethyl Esters 90 1000 mg Tablet


Capsule, Soft


Oral Use




Spain


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Spain


Ibsa Farmaceutici Italia


Omegoil


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




Sweden


Strides Arcolab International Limited


Megazza Strides


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




United Kingdom


Pronova Biopharma Norge As


Omacor


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




United Kingdom


Teva Uk Limited


Omega 3-Acid-Ethyl Esters Teva Uk


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




United Kingdom


Strides Arcolab International Limited


Omega-3-Acid Ethyl Esters Strides Arcolab International Limited


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




United Kingdom


Teva Uk Limited


Prestylon


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use




United Kingdom


Mercury Pharmaceuticals Ltd


Teromeg


Omega-3-Acid Ethyl Esters 90 1000 mg Capsule


Capsule, Soft


Oral Use