# Official Journal C 104/27 M

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 104 |
| | |
| English edition | Information and Notices | Volume 5827 March 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 104

English edition

Information and Notices

Volume 5827 March 2015

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 104/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2015 to 28 February 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2015/C 104/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2015(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 10 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2015/C 104/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2015 to 28 February 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2015/C 104/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2015(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

10

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.3.2015 | EN | Official Journal of the European Union | C 104/1 |
| --- | --- | --- | --- |

27.3.2015

EN

Official Journal of the European Union

C 104/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2015 to 28 February 2015

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2015/C 104/01)

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.2.2015 | Holoclar | Ex vivo expanded autologous human corneal epithelial cells containing stem cells | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | Living tissue equivalent | S01XA19 | 19.2.2015 |
| 17.2.2015 | Tyverb | lapatinib | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/440 | Film-coated tablet | L01XE07 | 19.2.2015 |
| 19.2.2015 | Clopidogrel ratiopharm | clopidogrel | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/975 | Film-coated tablet | B01AC04 | 24.2.2015 |
| 19.2.2015 | Xydalba | Dalbavancin | Durata Therapeutics International B.V.
  Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland | EU/1/14/986 | Powder for concentrate for solution for infusion | J01XA04 | 23.2.2015 |
| 24.2.2015 | Xadago | safinamide | Zambon S.p.A.
  Via Lillo del Duca 10, 20091 Bresso (MI), Italia | EU/1/14/984 | Film-coated tablet | Pending | 26.2.2015 |
| 26.2.2015 | Tasermity | sevelamer hydrochloride | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/953 | Film-coated tablet | V03AE02 | 2.3.2015 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

17.2.2015

Holoclar

Ex vivo expanded autologous human corneal epithelial cells containing stem cells

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

Living tissue equivalent

S01XA19

19.2.2015

17.2.2015

Tyverb

lapatinib

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/07/440

Film-coated tablet

L01XE07

19.2.2015

19.2.2015

Clopidogrel ratiopharm

clopidogrel

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/975

Film-coated tablet

B01AC04

24.2.2015

19.2.2015

Xydalba

Dalbavancin

Durata Therapeutics International B.V.

Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland

EU/1/14/986

Powder for concentrate for solution for infusion

J01XA04

23.2.2015

24.2.2015

Xadago

safinamide

Zambon S.p.A.

Via Lillo del Duca 10, 20091 Bresso (MI), Italia

EU/1/14/984

Film-coated tablet

Pending

26.2.2015

26.2.2015

Tasermity

sevelamer hydrochloride

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/953

Film-coated tablet

V03AE02

2.3.2015

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.2.2015 | Levetiracetam Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/11/701 | 5.2.2015 |
| 3.2.2015 | Pergoveris | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/07/396 | 6.2.2015 |
| 6.2.2015 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 10.2.2015 |
| 6.2.2015 | Bridion | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/466 | 10.2.2015 |
| 6.2.2015 | Ceplene | Meda AB
  Box 906, SE-170 09 Solna, Sverige | EU/1/08/477 | 10.2.2015 |
| 6.2.2015 | Filgrastim Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/08/496 | 10.2.2015 |
| 6.2.2015 | Firazyr | Shire Orphan Therapies GmbH
  Friedrichstraße 149, D-10117 Berlin, Deutschland | EU/1/08/461 | 10.2.2015 |
| 6.2.2015 | Herceptin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145 | 10.2.2015 |
| 6.2.2015 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 10.2.2015 |
| 6.2.2015 | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/11/741 | 10.2.2015 |
| 6.2.2015 | Opgenra | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/08/489 | 10.2.2015 |
| 6.2.2015 | Raloxifene Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/10/627 | 11.2.2015 |
| 6.2.2015 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 10.2.2015 |
| 6.2.2015 | Zarzio | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/08/495 | 10.2.2015 |
| 10.2.2015 | Replagal | Shire Human Genetic Therapies AB
  Svärdvägen 11D, SE-182 33 Danderyd, Sverige | EU/1/01/189 | 12.2.2015 |
| 10.2.2015 | Telmisartan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/610 | 12.2.2015 |
| 10.2.2015 | Telmisartan Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/719 | 12.2.2015 |
| 10.2.2015 | Tybost | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/872 | 12.2.2015 |
| 11.2.2015 | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 13.2.2015 |
| 11.2.2015 | HBVAXPRO | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/01/183 | 13.2.2015 |
| 11.2.2015 | Hepsera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/03/251 | 13.2.2015 |
| 11.2.2015 | Olanzapine Apotex | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/10/635 | 16.2.2015 |
| 11.2.2015 | Ribavirin Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/10/634 | 13.2.2015 |
| 11.2.2015 | Somavert | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/240 | 13.2.2015 |
| 11.2.2015 | Tyverb | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/440 | 13.2.2015 |
| 11.2.2015 | Vitekta | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/883 | 13.2.2015 |
| 11.2.2015 | Zoledronic acid Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/12/800 | 13.2.2015 |
| 12.2.2015 | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/11/667 | 16.2.2015 |
| 17.2.2015 | Arzerra | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/10/625 | 19.2.2015 |
| 17.2.2015 | Lantus | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/134 | 19.2.2015 |
| 17.2.2015 | Oprymea | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/469 | 19.2.2015 |
| 17.2.2015 | Optisulin | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/133 | 19.2.2015 |
| 17.2.2015 | Renagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/99/123 | 19.2.2015 |
| 17.2.2015 | Sutent | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/347 | 19.2.2015 |
| 17.2.2015 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 19.2.2015 |
| 19.2.2015 | Abilify | Otsuka Pharmaceutical Europe Ltd.
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/04/276 | 23.2.2015 |
| 19.2.2015 | EVARREST | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/13/868 | 23.2.2015 |
| 19.2.2015 | Fertavid | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/510 | 23.2.2015 |
| 19.2.2015 | Memantine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/880 | 23.2.2015 |
| 19.2.2015 | Mixtard | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/231 | 23.2.2015 |
| 19.2.2015 | NeuroBloc | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/166 | 23.2.2015 |
| 19.2.2015 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 23.2.2015 |
| 19.2.2015 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 23.2.2015 |
| 19.2.2015 | RotaTeq | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/348 | 23.2.2015 |
| 19.2.2015 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 23.2.2015 |
| 24.2.2015 | Aloxi | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/04/306 | 26.2.2015 |
| 24.2.2015 | Eylea | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/12/797 | 26.2.2015 |
| 24.2.2015 | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | 26.2.2015 |
| 24.2.2015 | Hexyon | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/13/829 | 26.2.2015 |
| 26.2.2015 | Abraxane | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/07/428 | 2.3.2015 |
| 26.2.2015 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 2.3.2015 |
| 26.2.2015 | Brimica Genuair | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/963 | 2.3.2015 |
| 26.2.2015 | Duaklir Genuair | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/964 | 2.3.2015 |
| 26.2.2015 | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 2.3.2015 |
| 26.2.2015 | Lysodren | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/04/273 | 2.3.2015 |
| 26.2.2015 | Prevenar 13 | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/590 | 2.3.2015 |
| 26.2.2015 | Yellox | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/11/692 | 2.3.2015 |
| 26.2.2015 | Ziagen | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/99/112 | 2.3.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.2.2015

Levetiracetam Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/701

5.2.2015

3.2.2015

Pergoveris

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/07/396

6.2.2015

6.2.2015

Adenuric

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/447

10.2.2015

6.2.2015

Bridion

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/466

10.2.2015

6.2.2015

Ceplene

Meda AB

Box 906, SE-170 09 Solna, Sverige

EU/1/08/477

10.2.2015

6.2.2015

Filgrastim Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/08/496

10.2.2015

6.2.2015

Firazyr

Shire Orphan Therapies GmbH

Friedrichstraße 149, D-10117 Berlin, Deutschland

EU/1/08/461

10.2.2015

6.2.2015

Herceptin

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145

10.2.2015

6.2.2015

Leflunomide ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/10/654

10.2.2015

6.2.2015

Levetiracetam SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/11/741

10.2.2015

6.2.2015

Opgenra

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/08/489

10.2.2015

6.2.2015

Raloxifene Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/627

11.2.2015

6.2.2015

Vimpat

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

10.2.2015

6.2.2015

Zarzio

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/08/495

10.2.2015

10.2.2015

Replagal

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/01/189

12.2.2015

10.2.2015

Telmisartan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/610

12.2.2015

10.2.2015

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

12.2.2015

10.2.2015

Tybost

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/872

12.2.2015

11.2.2015

Champix

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

13.2.2015

11.2.2015

HBVAXPRO

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/01/183

13.2.2015

11.2.2015

Hepsera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/251

13.2.2015

11.2.2015

Olanzapine Apotex

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/10/635

16.2.2015

11.2.2015

Ribavirin Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/10/634

13.2.2015

11.2.2015

Somavert

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/240

13.2.2015

11.2.2015

Tyverb

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/07/440

13.2.2015

11.2.2015

Vitekta

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/883

13.2.2015

11.2.2015

Zoledronic acid Hospira

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/12/800

13.2.2015

12.2.2015

Esbriet

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/11/667

16.2.2015

17.2.2015

Arzerra

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/10/625

19.2.2015

17.2.2015

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

19.2.2015

17.2.2015

Oprymea

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469

19.2.2015

17.2.2015

Optisulin

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

19.2.2015

17.2.2015

Renagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/123

19.2.2015

17.2.2015

Sutent

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/347

19.2.2015

17.2.2015

Vidaza

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom

EU/1/08/488

19.2.2015

19.2.2015

Abilify

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/04/276

23.2.2015

19.2.2015

EVARREST

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/13/868

23.2.2015

19.2.2015

Fertavid

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/510

23.2.2015

19.2.2015

Memantine Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/13/880

23.2.2015

19.2.2015

Mixtard

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231

23.2.2015

19.2.2015

NeuroBloc

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/00/166

23.2.2015

19.2.2015

Revlimid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/07/391

23.2.2015

19.2.2015

Reyataz

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267

23.2.2015

19.2.2015

RotaTeq

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/348

23.2.2015

19.2.2015

Victrelis

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/11/704

23.2.2015

24.2.2015

Aloxi

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

26.2.2015

24.2.2015

Eylea

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

26.2.2015

24.2.2015

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/13/828

26.2.2015

24.2.2015

Hexyon

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/13/829

26.2.2015

26.2.2015

Abraxane

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom

EU/1/07/428

2.3.2015

26.2.2015

Bosulif

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

2.3.2015

26.2.2015

Brimica Genuair

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/14/963

2.3.2015

26.2.2015

Duaklir Genuair

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/14/964

2.3.2015

26.2.2015

Epivir

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/96/015

2.3.2015

26.2.2015

Lysodren

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/04/273

2.3.2015

26.2.2015

Prevenar 13

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/09/590

2.3.2015

26.2.2015

Yellox

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/11/692

2.3.2015

26.2.2015

Ziagen

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/99/112

2.3.2015

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 11.2.2015 | Pumarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/10/664 | 13.2.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

11.2.2015

Pumarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/10/664

13.2.2015

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.2.2015 | Zulvac SBV | Inactivated Schmallenberg virus, strain BH80/11-4 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/178 | Suspension for injection | QI02AA | 10.2.2015 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.2.2015

Zulvac SBV

Inactivated Schmallenberg virus, strain BH80/11-4

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/178

Suspension for injection

QI02AA

10.2.2015

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 17.2.2015 | BTVPUR AlSap 1 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/112 | 19.2.2015 |
| 17.2.2015 | BTVPUR AlSap 1-8 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/113 | 19.2.2015 |
| 19.2.2015 | Nobivac Myxo-RHD | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/132 | 23.2.2015 |
| 26.2.2015 | CERTIFECT | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/11/125 | 2.3.2015 |
| 26.2.2015 | ECOPORC SHIGA | IDT Biologika GmbH
  Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | EU/2/13/149 | 2.3.2015 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

17.2.2015

BTVPUR AlSap 1

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/112

19.2.2015

17.2.2015

BTVPUR AlSap 1-8

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/113

19.2.2015

19.2.2015

Nobivac Myxo-RHD

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/11/132

23.2.2015

26.2.2015

CERTIFECT

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/11/125

2.3.2015

26.2.2015

ECOPORC SHIGA

IDT Biologika GmbH

Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland

EU/2/13/149

2.3.2015

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 27.3.2015 | EN | Official Journal of the European Union | C 104/10 |
| --- | --- | --- | --- |

27.3.2015

EN

Official Journal of the European Union

C 104/10

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2015

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

(2015/C 104/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 11.2.2015 | Gentamicin | See Annex I | See Annex I | See Annex I | 13.2.2015 |

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

11.2.2015

Gentamicin

See Annex I

See Annex I

See Annex I

13.2.2015

---

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

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

---

ANNEX I

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States

| Member State EU/EEA | Applicant/Marketing Authorisation Holder | Product name | INN | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Vana GmbH
  Wolfgang Schmälzl Gasse 6
  1020 Wien
  Austria | Gentavan 5 %-Durchstichflasche für Tiere | Gentamicin (as gentamicin sulphate) | 50 mg/ml | Solution for injection | Horse, foal, cattle, calf, pig, dog, cat |
| Belgium | EMDOKA bvba
  John Lijsenstraat 16
  B-2321 Hoogstraten
  Belgium | Emdogent 100 | Gentamicin | 100 mg/ml | Solution for injection | Horses, cattle, pigs, dogs and cats |
| Belgium | Franklin Pharmaceuticals Ltd.
  Athboy Road
  Trim
  Co. Meath
  Ireland | Genta Equine | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Horses (non food producing horses) |
| Croatia | Krka — Farma d.o.o.
  Radnička cesta 48
  10000 Zagreb
  Croatia | GENTAMICIN 8 % | Gentamicin (as gentamicin sulphate) | 80 mg/ml | Solution for injection | Cattle, horses (non-food producing), pigs, dogs and cats |
| Croatia | PROPHARMA VET d.o.o.
  Vijenac A. Cesarca 16
  31000 Osijek
  Croatia | NEOGENT | Gentamicin (as gentamicin sulphate) | 80 mg/ml | Solution for injection | Cattle, pigs, horses, dogs, cats |
| Czech Republic | FATRO S.p.A.
  Via Emilia 285
  Ozzano Emilia (Bologna)
  Italy | AAGENT 50 mg/ml injekční roztok | Gentamicin | 50 mg/ml | Solution for injection | Calves, foals and piglets at the age of one month |
| Denmark | Franklin Pharmaceuticals Ltd.
  Athboy Road
  Trim
  Co. Meath
  Ireland | Genta Equine | Gentamicin | 100 mg/ml | Solution for injection | Horses |
| Estonia | Interchemie werken ‘De Adelaar’ Eesti AS
  Vanapere tee 14, Pringi
  74001 Viimsi
  Harjumaa
  Estonia | Genta-100 EE | Gentamicin | 100 mg/ml | Solution for injection | Cattle, horse, swine |
| Germany | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13
  31303 Burgdorf
  Germany | Genta 100 mg/ml | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog |
| Germany | Bela-Pharm GmbH & Co. KG
  Lohner Str. 19
  49377 Vechta
  Germany | Gentacin | Gentamicin (as gentamicin sulphate) | 50 mg/ml | Solution for injection | Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog |
| Germany | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Gentamicin 50 | Gentamicin (as gentamicin sulphate) | 50 mg/ml | Solution for injection | Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog |
| Germany | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Genta-Sulfat 81 | Gentamicin (as gentamicin sulphate) | 50 mg/ml | Solution for injection | Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog |
| Germany | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Vepha-Gent forte | Gentamicin (as gentamicin sulphate) | 50 mg/ml | Solution for injection | Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog |
| Germany | Bela-Pharm GmbH & Co. KG
  Lohner Str. 19
  49377 Vechta
  Germany | Vetogent Inj. | Gentamicin (as gentamicin sulphate) | 50 mg/ml | Solution for injection | Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog |
| Iceland | Franklin Pharmaceuticals Ltd.
  Athboy Road
  Trim
  Co. Meath
  Ireland | Genta Equine | Gentamicin | 100 mg/ml | Solution for injection | Horses |
| Ireland | Franklin Pharmaceuticals Ltd.
  Athboy Road
  Trim
  Co. Meath
  Ireland | Gentaject 10 % Solution for Injection | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Horses declared as not being intended for slaughter for human consumption |
| Latvia | CP — Pharma Handelsges. mbH
  Ostlalandring 13
  31303 Burgdorf,
  Germany | Genta 100 | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Cats, cattle, dogs, horses |
| Latvia | Huvepharma AD
  33 James Boucher Blvd.
  Sofia 1407
  Bulgaria | Gentacin | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Pigs, cats, cattle, dogs, horses |
| Latvia | KELA N.V.
  St. Lenaartseweg 48
  2320 Hoogstraten
  Belgium | Genta-kel 10 % | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Pigs, cattle, dogs, horses |
| Latvia | Bela-pharm GmbH & Co.KG
  Lohner Str. 19
  49377 Vechta
  Germany | Gentamycin 5 | Gentamicin (as gentamicin sulphate) | 85 mg/ml | Solution for injection | Pigs, cats, cattle, dogs, horses |
| Lithuania | CP — Pharma Handelsges. mbH
  Ostlalandring 13
  31303 Burgdorf
  Germany | Genta 100 mg/ml, injekcinis tirpalas | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Cats, dogs, cattle, pigs, horses |
| Lithuania | Bela-pharm GmbH & Co.KG
  Lohner Str. 19
  49377 Vechta
  Germany | Gentacin, injekcinis tirpalas | Gentamicin (as gentamicin sulphate) | 85 mg/ml | Solution for injection | Horse, foal, cattle, calf, pig, piglet, weaner, dog and cat |
| Lithuania | Dopharma Research B.V.
  Zalmweg 24m 4941 VX Raamsdonksveer
  the Netherlands | GENTA-JECT, injekcinis tirpalas | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Cattle, calves, pigs, piglets, horses, cats and dogs |
| Lithuania | LABORATORIOS SYVA, S.A.
  Av. Párroco Pablo Díez, 49-57
  24010, León
  Spain | GENTAYET 40 mg/ml injekcinis tirpalas arkliams, galvijams, kiaulėms, šunims ir katėms | Gentamicin | 40 mg/ml | Solution for injection | Bovine, equine, pigs, dogs and cats |
| Malta | Laboratorios Calier S.A Barcelones
  26 Place del Ramass
  Les Franqueses del valles
  Barcelona
  Spain | GENTACALIER | Gentamicin | 40 mg/ml | Solution for injection | Dog, cat, pig, piglets, cattle, calves, horses |
| Portugal | IAPSA PORTUGUESA PECUÁRIA, LDA
  Avenida do Brasil no 88 7o Esq
  1700-073 Lisboa
  Portugal | GENTAYET 40 mg/ml solução injectável | Gentamicin | 40 mg/ml | Solution for injection | Cattle, horses, dogs and cats |
| Slovakia | Fatro S.p.A.
  Via Emilia 285
  Ozzano Emília
  Bologna
  Italy | Aagent 50 mg/ml injekčný roztok | Gentamicin | 50 mg/ml | Solution for injection | Foals, calves, sucklings — the first month of life |
| Spain | SUPER'S DIANA, S.L
  Ctra. Barcelona — Ripoll, Km 17
  08150 Parets del Vallès
  Barcelona
  Spain | GENDIAN-400 | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | SUPER'S DIANA, S.L
  Ctra. Barcelona — Ripoll, Km 17
  08150 Parets del Vallès
  Barcelona
  Spain | GENDIAN-600 | Gentamicin (as gentamicin sulphate) | 60 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | FATRO IBERICA, S.L.
  Constitución, 1 Planta baja 3
  08960 Sant Just Desvern
  Barcelona
  Spain | GENTA 50 | Gentamicin (as gentamicin sulphate) | 50 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | Franklin Pharmaceuticals Ltd.
  Athboy Road
  Trim
  Co. Meath
  Ireland | Genta Equine 100 mg/ml Solution for injection | Gentamicin (as gentamicin sulphate) | 100 mg/ml | Solution for injection | Horses (non food producing horse) |
| Spain | LABORATORIOS CALIER, S.A.
  C/Barcelonés, 26
  08520 Les Franqueses del Valles
  Barcelona
  Spain | GENTACALIER | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | POLICHEM S.L.U.
  C/Prudenci Bertrana, 5
  Polígono Industrial Agro-Reus
  Reus
  43206 Tarragona
  Spain | GENTACHEM | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | B.BRAUN VETCARE, S.A.
  Crta. Tarrasa, 121
  Rubí
  Barcelona
  Spain | GENTAMICINA 6 % BRAUN USO VETERINARIO | Gentamicin (as gentamicin sulphate) | 60 mg/ml | Solution for injection | Equine not intended for human consumption, dogs, cats |
| Spain | Industrial Veterinaria, S.A.
  Esmeralda, 19
  08950 Esplugues de Llobregat
  Barcelona
  Spain | GENTAMICINA GANADEXIL | Gentamicin (as gentamicin sulphate) | 35 mg/ml | Solution for injection | Horses, cattle, dogs and cats |
| Spain | Laboratorios e Industrias IVEN, S.A.
  Polígono Industrial de Vallecas.
  C/Luis I s/n.
  28031 Madrid
  Spain | GENTAMICIVEN | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | LABIANA LIFE SCIENCE, S.A.
  C/Venus, 26
  Can Parellada Industrial Terrassa
  08228 Barcelona
  Spain | GENTASOL 80 | Gentamicin (as gentamicin sulphate) | 80 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | MEVET, S.A.U
  Poligono Industrial El Segre, Parcela 409-410
  25191 Lérida
  Spain | GENTAVALL 40 MG/ML SOLUCIÓN INYECTABLE | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Spain | LABORATORIOS SYVA, S.A.U.
  Avda. Parroco Pablo Diez, 49-57
  24010 León
  Spain | GENTAYET | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle, pigs, dogs and cats |
| Spain | LABORATORIOS MAYMO, S.A.
  Via Augusta, 302
  08017 Barcelona
  Spain | MAYCOLI INYECTABLE | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle and pigs |
| Spain | CENAVISA
  Camí Pedra Estela s/n
  43205 Reus
  Tarragona)
  Spain | PURMICINA 40 MG/ML SOLUCIÓN INYECTABLE | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats |
| Spain | Laboratorios e Industrias IVEN, S.A
  Luis I, 56
  Poligono Industrial Vallecas
  28031 Madrid
  Spain | VETERSAN GENTAMICINA | Gentamicin (as gentamicin sulphate) | 40 mg/ml | Solution for injection | Non food-producing horses, cattle, dogs and cats |
| Sweden | Franklin Pharmaceuticals Ltd.
  Athboy Road
  Trim
  Co. Meath
  Ireland | Gentaject vet | Gentamicin | 100 mg/ml | Solution for injection | Horse |
| United Kingdom | Franklin Pharmaceuticals Ltd.
  Athboy Road
  Trim
  Co. Meath
  Ireland | Genta-Equine 100 mg/ml Solution for Injection for Horses | Gentamicin | 100 mg/ml | Solution for injection | Horses (non-food producing) |

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Austria

Vana GmbH

Wolfgang Schmälzl Gasse 6

1020 Wien

Austria

Gentavan 5 %-Durchstichflasche für Tiere

Gentamicin (as gentamicin sulphate)

50 mg/ml

Solution for injection

Horse, foal, cattle, calf, pig, dog, cat

Belgium

EMDOKA bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Emdogent 100

Gentamicin

100 mg/ml

Solution for injection

Horses, cattle, pigs, dogs and cats

Belgium

Franklin Pharmaceuticals Ltd.

Athboy Road

Trim

Co. Meath

Ireland

Genta Equine

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Horses (non food producing horses)

Croatia

Krka — Farma d.o.o.

Radnička cesta 48

10000 Zagreb

Croatia

GENTAMICIN 8 %

Gentamicin (as gentamicin sulphate)

80 mg/ml

Solution for injection

Cattle, horses (non-food producing), pigs, dogs and cats

Croatia

PROPHARMA VET d.o.o.

Vijenac A. Cesarca 16

31000 Osijek

Croatia

NEOGENT

Gentamicin (as gentamicin sulphate)

80 mg/ml

Solution for injection

Cattle, pigs, horses, dogs, cats

Czech Republic

FATRO S.p.A.

Via Emilia 285

Ozzano Emilia (Bologna)

Italy

AAGENT 50 mg/ml injekční roztok

Gentamicin

50 mg/ml

Solution for injection

Calves, foals and piglets at the age of one month

Denmark

Franklin Pharmaceuticals Ltd.

Athboy Road

Trim

Co. Meath

Ireland

Genta Equine

Gentamicin

100 mg/ml

Solution for injection

Horses

Estonia

Interchemie werken ‘De Adelaar’ Eesti AS

Vanapere tee 14, Pringi

74001 Viimsi

Harjumaa

Estonia

Genta-100 EE

Gentamicin

100 mg/ml

Solution for injection

Cattle, horse, swine

Germany

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13

31303 Burgdorf

Germany

Genta 100 mg/ml

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog

Germany

Bela-Pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Gentacin

Gentamicin (as gentamicin sulphate)

50 mg/ml

Solution for injection

Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog

Germany

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Gentamicin 50

Gentamicin (as gentamicin sulphate)

50 mg/ml

Solution for injection

Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog

Germany

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Genta-Sulfat 81

Gentamicin (as gentamicin sulphate)

50 mg/ml

Solution for injection

Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog

Germany

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Vepha-Gent forte

Gentamicin (as gentamicin sulphate)

50 mg/ml

Solution for injection

Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog

Germany

Bela-Pharm GmbH & Co. KG

Lohner Str. 19

49377 Vechta

Germany

Vetogent Inj.

Gentamicin (as gentamicin sulphate)

50 mg/ml

Solution for injection

Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog

Iceland

Franklin Pharmaceuticals Ltd.

Athboy Road

Trim

Co. Meath

Ireland

Genta Equine

Gentamicin

100 mg/ml

Solution for injection

Horses

Ireland

Franklin Pharmaceuticals Ltd.

Athboy Road

Trim

Co. Meath

Ireland

Gentaject 10 % Solution for Injection

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Horses declared as not being intended for slaughter for human consumption

Latvia

CP — Pharma Handelsges. mbH

Ostlalandring 13

31303 Burgdorf,

Germany

Genta 100

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Cats, cattle, dogs, horses

Latvia

Huvepharma AD

33 James Boucher Blvd.

Sofia 1407

Bulgaria

Gentacin

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Pigs, cats, cattle, dogs, horses

Latvia

KELA N.V.

St. Lenaartseweg 48

2320 Hoogstraten

Belgium

Genta-kel 10 %

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Pigs, cattle, dogs, horses

Latvia

Bela-pharm GmbH & Co.KG

Lohner Str. 19

49377 Vechta

Germany

Gentamycin 5

Gentamicin (as gentamicin sulphate)

85 mg/ml

Solution for injection

Pigs, cats, cattle, dogs, horses

Lithuania

CP — Pharma Handelsges. mbH

Ostlalandring 13

31303 Burgdorf

Germany

Genta 100 mg/ml, injekcinis tirpalas

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Cats, dogs, cattle, pigs, horses

Lithuania

Bela-pharm GmbH & Co.KG

Lohner Str. 19

49377 Vechta

Germany

Gentacin, injekcinis tirpalas

Gentamicin (as gentamicin sulphate)

85 mg/ml

Solution for injection

Horse, foal, cattle, calf, pig, piglet, weaner, dog and cat

Lithuania

Dopharma Research B.V.

Zalmweg 24m 4941 VX Raamsdonksveer

the Netherlands

GENTA-JECT, injekcinis tirpalas

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Cattle, calves, pigs, piglets, horses, cats and dogs

Lithuania

LABORATORIOS SYVA, S.A.

Av. Párroco Pablo Díez, 49-57

24010, León

Spain

GENTAYET 40 mg/ml injekcinis tirpalas arkliams, galvijams, kiaulėms, šunims ir katėms

Gentamicin

40 mg/ml

Solution for injection

Bovine, equine, pigs, dogs and cats

Malta

Laboratorios Calier S.A Barcelones

26 Place del Ramass

Les Franqueses del valles

Barcelona

Spain

GENTACALIER

Gentamicin

40 mg/ml

Solution for injection

Dog, cat, pig, piglets, cattle, calves, horses

Portugal

IAPSA PORTUGUESA PECUÁRIA, LDA

Avenida do Brasil no 88 7o Esq

1700-073 Lisboa

Portugal

GENTAYET 40 mg/ml solução injectável

Gentamicin

40 mg/ml

Solution for injection

Cattle, horses, dogs and cats

Slovakia

Fatro S.p.A.

Via Emilia 285

Ozzano Emília

Bologna

Italy

Aagent 50 mg/ml injekčný roztok

Gentamicin

50 mg/ml

Solution for injection

Foals, calves, sucklings — the first month of life

Spain

SUPER'S DIANA, S.L

Ctra. Barcelona — Ripoll, Km 17

08150 Parets del Vallès

Barcelona

Spain

GENDIAN-400

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

SUPER'S DIANA, S.L

Ctra. Barcelona — Ripoll, Km 17

08150 Parets del Vallès

Barcelona

Spain

GENDIAN-600

Gentamicin (as gentamicin sulphate)

60 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

FATRO IBERICA, S.L.

Constitución, 1 Planta baja 3

08960 Sant Just Desvern

Barcelona

Spain

GENTA 50

Gentamicin (as gentamicin sulphate)

50 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

Franklin Pharmaceuticals Ltd.

Athboy Road

Trim

Co. Meath

Ireland

Genta Equine 100 mg/ml Solution for injection

Gentamicin (as gentamicin sulphate)

100 mg/ml

Solution for injection

Horses (non food producing horse)

Spain

LABORATORIOS CALIER, S.A.

C/Barcelonés, 26

08520 Les Franqueses del Valles

Barcelona

Spain

GENTACALIER

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

POLICHEM S.L.U.

C/Prudenci Bertrana, 5

Polígono Industrial Agro-Reus

Reus

43206 Tarragona

Spain

GENTACHEM

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

B.BRAUN VETCARE, S.A.

Crta. Tarrasa, 121

Rubí

Barcelona

Spain

GENTAMICINA 6 % BRAUN USO VETERINARIO

Gentamicin (as gentamicin sulphate)

60 mg/ml

Solution for injection

Equine not intended for human consumption, dogs, cats

Spain

Industrial Veterinaria, S.A.

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona

Spain

GENTAMICINA GANADEXIL

Gentamicin (as gentamicin sulphate)

35 mg/ml

Solution for injection

Horses, cattle, dogs and cats

Spain

Laboratorios e Industrias IVEN, S.A.

Polígono Industrial de Vallecas.

C/Luis I s/n.

28031 Madrid

Spain

GENTAMICIVEN

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

LABIANA LIFE SCIENCE, S.A.

C/Venus, 26

Can Parellada Industrial Terrassa

08228 Barcelona

Spain

GENTASOL 80

Gentamicin (as gentamicin sulphate)

80 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

MEVET, S.A.U

Poligono Industrial El Segre, Parcela 409-410

25191 Lérida

Spain

GENTAVALL 40 MG/ML SOLUCIÓN INYECTABLE

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Spain

LABORATORIOS SYVA, S.A.U.

Avda. Parroco Pablo Diez, 49-57

24010 León

Spain

GENTAYET

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle, pigs, dogs and cats

Spain

LABORATORIOS MAYMO, S.A.

Via Augusta, 302

08017 Barcelona

Spain

MAYCOLI INYECTABLE

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle and pigs

Spain

CENAVISA

Camí Pedra Estela s/n

43205 Reus

Tarragona)

Spain

PURMICINA 40 MG/ML SOLUCIÓN INYECTABLE

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats

Spain

Laboratorios e Industrias IVEN, S.A

Luis I, 56

Poligono Industrial Vallecas

28031 Madrid

Spain

VETERSAN GENTAMICINA

Gentamicin (as gentamicin sulphate)

40 mg/ml

Solution for injection

Non food-producing horses, cattle, dogs and cats

Sweden

Franklin Pharmaceuticals Ltd.

Athboy Road

Trim

Co. Meath

Ireland

Gentaject vet

Gentamicin

100 mg/ml

Solution for injection

Horse

United Kingdom

Franklin Pharmaceuticals Ltd.

Athboy Road

Trim

Co. Meath

Ireland

Genta-Equine 100 mg/ml Solution for Injection for Horses

Gentamicin

100 mg/ml

Solution for injection

Horses (non-food producing)

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