# C_2019252EN.01001501.xml

| 26.7.2019 | EN | Official Journal of the European Union | C 252/15 |
| --- | --- | --- | --- |

26.7.2019

EN

Official Journal of the European Union

C 252/15

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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 |
| --- | --- |

—

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 |

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

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(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

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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 |

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

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