22 March 2018 EMA/197481/2018 Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, applicants, marketing authorisation holders in the member states for for omega-3 acid ethyl esters containing medicinal products for oral in use in prevention after myocardial infarction Referral under Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1464 Please note that this draft Annex I will be updated to amend information on concerned products/mahs 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Austria Austria Zodin Belgium Belgium Ibsa Farmaceutici Trimacor Italia Bulgaria Омакор Croatia Pliva Hrvatska D.O.O. Corprotect Croatia Mylan Hrvatska Dualtis D.O.O. Croatia Mylan Hrvatska D.O.O. Cyprus EMA/197481/2018 Page 2/16
Denmark Strides Arcolab International Limited Megazza Strides Estonia France Eg Labo Laboratoires Eurogenerics Esters Ethyliques D acides Omega 3 Eg Labo Conseil France Laboratoires Genevrier Esters Ethyliques D acides Omega-3 Genevrier France France Pierre Fabre Medicament Ysomega Omega-3-Acid Triglycerides 1000mg France Zodin Germany Germany Glenmark Pharmaceuticals Europe Limited Omega 3 EMA/197481/2018 Page 3/16
Germany Biomo Pharma Gmbh Omega-3 Germany Ntc Srl Omega-3 Ntc Germany Ratiopharm Gmbh Omega-3 Ratiopharm Germany Heumann Pharma Omega-3- Gmbh & Co. Generica Kg Säurenethylester 90 Heumann Germany Ibsa Farmaceutici Omegoil Italia Germany Zodin Omega-3 Bennett Becolip Pharmaceuticals Sa Zwitter Pharmaceuticals Επε Dynapen-3 Fish Oil 1000mg EMA/197481/2018 Page 4/16
Pharmanel Commercial Pharmaceutical S.A. Eicodol Ethyl Ester 460mg, Ethyl Ester 380mg Heremco Emfrastop 527mg/5ml, 791mg/5ml Alapis Abee Epadoc 527mg/5ml, Vitamin D 10 I.U.G, 791mg/5ml, Vitamin A 100 I.U.G Mediapharm Ltd Farlipid 115mg, Vitamin D 1 I.U.G, 170mg, Vitamin A 1 I.U.G Mediapharm Ltd Farlipid 265mg/5ml, 390mg/5ml Oral Solution Oral Solution Oral Emulsion EMA/197481/2018 Page 5/16
Mediapharm Ltd Farlipid Oral Solution 527mg/5ml, 791mg/5ml Naturalia S.A. Hemido Ethyl Ester 460mg, Ethyl Ester 380mg Verisfield (Uk) Ltd Lipemia 115mg, 170mg Verisfield (Uk) Ltd Lipemia Fish Oil 0.5ml/Ml Oral Emulsion Verisfield (Uk) Ltd Lipemia Forte Esters 1000mg Rafarm Sa. Loitrol Oral Solution 115mgg, 170μgg Trygg Pharma As Lypiad Ethyl Ester 460mg, Ethyl Ester 380mg EMA/197481/2018 Page 6/16
Pharmanel Commercial Pharmaceutical S.A. Macoil Esters 1000mg Cana S.A. Farmakeftika Ergastiria Maxepa 115mg, Vitamin D 10 I.U.G, 170mg, Vitamin A 100 I.U.G Cana S.A. Farmakeftika Ergastiria Maxepa 527mg/5ml, Vitamin D 10 I.U.G, 791mg/5ml, Vitamin A 100 I.U.G Oral Solution Bgp Products Ltd () Trygg Pharma As Omega-3-Acid-Ethyl- Ester/Lomegar Ethyl Ester 460mg, Ethyl Ester 380mg Novendia Pharmaceuticals Ltd Pazeril 115mg, Eicosapentanoic Acid/Docosahexaenoic Acid 170mg EMA/197481/2018 Page 7/16
Novendia Pharmaceuticals Ltd Pazeril 527mg/5ml, Eicosapentanoic Acid/Docosahexaenoic Acid 791mg/5ml Uni-Pharma Kleon Prolipid Tsetis Pharmaceutical 120mg, Laboratories S.A. 180mg Uni-Pharma Kleon Prolipid Tsetis Pharmaceutical 60mg, Laboratories S.A. 90mg Pharmanel Sea-Oil Commercial Ethyl Ester 460mg Pharmaceutical S.A., Ethyl Ester 380mg Ioulia And Irene Tseti Tropolipid Pharmaceutical Ethyl Ester 430mg Laboratories S.A., Ethyl Ester 437mg Ferrer-Galenica S.A. Zodin Oral Solution EMA/197481/2018 Page 8/16
Hungary Hungary Ibsa Pharma Kft Panoil Ireland Ireland Clonmel Healthcare Trimega Ltd. Italy I.B.N. Savio S.R.L. Agemo Italy Pfizer Italia S.R.L. Esapent Esters Of Unsaturated Fatty Acids 1000mg Italy Pfizer Italia S.R.L. Esapent Esters Of Unsaturated Fatty Acids 500mg Italy Alfasigma S.P.A. Eskim Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%. 1000mg EMA/197481/2018 Page 9/16
Italy Alfasigma S.P.A. Eskim Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%. 500mg Italy Ibsa Farmaceutici Olevia Italia Italy Alfasigma S.P.A. Omega 3 Alfasigma Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%. 1000mg Italy S.P.A. Italiana Omega 3 Bouty Laboratori Bouty Italy Doc Generici S.R.L. Omega 3 Doc Esters Of Unsaturated Fatty Acids 1000mg Italy Doc Generici S.R.L. Omega 3 Doc Generici Italy Eg S.P.A. Omega 3 Eg Esters Of Unsaturated Fatty Acids 1000mg Italy Strides Arcolab Omega 3 Strides International Limited Arcolab International EMA/197481/2018 Page 10/16
Italy Teva Italia S.R.L. Omega 3 Teva Italy Altergon Italia S.R.L. Omegoil Italy Spa Società Prodotti Seacor Antibiotici S.P.A. Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%. 1000mg Italy Spa Società Prodotti Seacor Antibiotici S.P.A. Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%. 500mg Italy Alfasigma S.P.A. Trioreg Italy Piam Farmaceutici Triscudil S.P.A. Ethyl Ester 460mg, Ethyl Ester 380mg Latvia EMA/197481/2018 Page 11/16
Lithuania Luxembourg Luxembourg Ibsa Farmaceutici Italia Omegoil Malta Netherlands Netherlands Teva Nederland B.V. Omega-3 Vetzuren Ethylesters 90 Teva Netherlands Ibsa Farmaceutici Italia Omegoil Norway Poland EMA/197481/2018 Page 12/16
Portugal Ntc Srl Ésteres Etílicos 90 Do Ácido Omega-3 Ntc Portugal Pharmanel Commercial Pharmaceutical S.A. Ésteres Etílicos 90 Dos Ácidos Ómega-3 Pharmanel Esters 1000mg Portugal Portugal Ibsa Farmaceutici Italia Panoil Portugal Zodin Romania Romania Triglycerides Medium Chain 1qs, Lecithin Soya 1qs, Omega-3-Acid Ethyl Romania Teva Pharmaceuticals S.R.L Tevocor Omega-3 Fatty Acids 1000mg EMA/197481/2018 Page 13/16
Romania Ntc Srl Vasoteran Slovenia Slovenia Spain Aristo Pharma Iberia, Ácidos Omega 3 Aristo S.L. Esters 1000mg Spain Kern Pharma, S.L. Ácidos Omega 3 Kern Pharma Ethyl Ester 460mg, Ethyl Ester 380mg Spain Laboratorio Stada, Acidos Omega 3 Stada S.L. Spain Strides Arcolab Ácidos Omega 3 Strides International Limited EMA/197481/2018 Page 14/16
Spain Tarbis Farma, S.L. Ácidos Omega 3 Tarbis 380mg, 460mg, Omega- 3-Acid Ethyl Esters 90 1000mg Tablet Spain Spain Ibsa Farmaceutici Omegoil Italia Sweden Strides Arcolab Megazza Strides International Limited United Kingdom United Kingdom Teva Uk Limited Omega 3-Acid-Ethyl Esters Teva Uk United Kingdom Strides Arcolab International Limited Esters Strides Arcolab International Limited United Kingdom Teva Uk Limited Prestylon EMA/197481/2018 Page 15/16
United Kingdom Mercury Pharmaceuticals Ltd. Teromeg EMA/197481/2018 Page 16/16