# C_2013311EN.01000101.xml

| 25.10.2013 | EN | Official Journal of the European Union | C 311/1 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

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

2013/C 311/01

—   Issuing of a marketing authorization (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 |
| --------------------------------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------ | --------------------------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------ |
| 6.9.2013 | Procysbi | mercaptamine (cysteamine bitartrate) | Raptor Pharmaceuticals Europe BV Naritaweg 165, NL-1043 BW Amsterdam, Nederland | Raptor Pharmaceuticals Europe BV | Naritaweg 165, NL-1043 BW Amsterdam, Nederland | EU/1/13/861 | Gastro-resistant capsule, hard |
| Raptor Pharmaceuticals Europe BV | | | | | | | |
| Naritaweg 165, NL-1043 BW Amsterdam, Nederland | | | | | | | |
| 6.9.2013 | Provenge | Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T) | Dendreon UK Limited 41 Chalton Street, London NW1 1JD, United Kingdom | Dendreon UK Limited | 41 Chalton Street, London NW1 1JD, United Kingdom | EU/1/13/867 | Dispersion for infusion |
| Dendreon UK Limited | | | | | | | |
| 41 Chalton Street, London NW1 1JD, United Kingdom | | | | | | | |
| 10.9.2013 | Inflectra | Infliximab | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/13/854 | powder for concentrate for solution for infusion |
| Hospira UK Limited | | | | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | | | | |
| 10.9.2013 | Remsima | Infliximab | Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | Celltrion Healthcare Hungary Kft. | Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | EU/1/13/853 | powder for concentrate for solution for infusion |
| Celltrion Healthcare Hungary Kft. | | | | | | | |
| Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | | | | | | | |
| 12.9.2013 | Lemtrada | Alemtuzumab | Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | Genzyme Therapeutics Ltd | 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | Concentrate for solution for infusion |
| Genzyme Therapeutics Ltd | | | | | | | |
| 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | | | | | | | |
| 12.9.2013 | Orphacol | Cholic acid | Laboratoires CTRS (Cell Therapies Research & Services) 69 rue d’Aguesseau, F-92100 Boulogne-Billancourt, France | Laboratoires CTRS (Cell Therapies Research & Services) | 69 rue d’Aguesseau, F-92100 Boulogne-Billancourt, France | EU/1/13/870 | Capsule, hard |
| Laboratoires CTRS (Cell Therapies Research & Services) | | | | | | | |
| 69 rue d’Aguesseau, F-92100 Boulogne-Billancourt, France | | | | | | | |
| 19.9.2013 | Incresync | alogliptin / pioglitazone | Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/13/842 | Film-coated tablet |
| Takeda Pharma A/S | | | | | | | |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | | | | | | | |
| 19.9.2013 | Tybost | cobicistat | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT, United Kingdom | EU/1/13/872 | Film-coated tablet |
| Gilead Sciences International Limited | | | | | | | |
| Cambridge CB21 6GT, United Kingdom | | | | | | | |
| 19.9.2013 | Ultibro Breezhaler | indacaterol/glycopyrronium bromide | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/13/862 | Inhalation powder, hard capsule |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | | | | |
| 19.9.2013 | Vipdomet | alogliptin / metformin | Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/13/843 | Film-coated tablet |
| Takeda Pharma A/S | | | | | | | |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | | | | | | | |
| 19.9.2013 | Vipidia | alogliptin | Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/13/844 | Film-coated tablet |
| Takeda Pharma A/S | | | | | | | |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | | | | | | | |
| 19.9.2013 | Xoterna Breezhaler | indacaterol/glycopyrronium bromide | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/13/863 | Inhalation powder, hard capsule |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | | | | |
| 25.9.2013 | EVARREST | Human fibrinogen/Human thrombin | Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België | Omrix Biopharmaceuticals N.V. | Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/13/868 | Sealant matrix |
| Omrix Biopharmaceuticals N.V. | | | | | | | |
| Leonardo Da Vincilaan 15, B-1831 Diegem, België | | | | | | | |
| 25.9.2013 | Giotrif | afatinib | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/13/879 | Film-coated tablet |
| Boehringer Ingelheim International GmbH | | | | | | | |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | | | | | | | |
| 25.9.2013 | Imatinib Medac | Imatinib | medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/13/876 | Capsule, hard |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | | | | |
| Theaterstr. 6, D-22880 Wedel, Deutschland | | | | | | | |
| 27.9.2013 | Ovaleap | Follitropin alfa | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/13/871 | Solution for injection |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| -------------------------------------------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------------------------------------------------------- |
| 6.9.2013 | Labazenit | LABORATOIRES SMB SA 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België | LABORATOIRES SMB SA | 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België |
| LABORATOIRES SMB SA | | | | |
| 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België | | | | |

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------------------------------------------------------- |
| 3.9.2013 | Neulasta | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 3.9.2013 | Simponi | Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, NL-2333 CB Leiden, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland | | | | |
| 3.9.2013 | Vibativ | Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | Clinigen Healthcare Limited | Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |
| Clinigen Healthcare Limited | | | | |
| Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | | | | |
| 3.9.2013 | Victrelis | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 3.9.2013 | Xeplion | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 5.9.2013 | Mepact | Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France | Takeda France SAS | Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France |
| Takeda France SAS | | | | |
| Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France | | | | |
| 9.9.2013 | IDflu | Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France | Sanofi Pasteur SA | 2 avenue Pont Pasteur, F-69007 Lyon, France |
| Sanofi Pasteur SA | | | | |
| 2 avenue Pont Pasteur, F-69007 Lyon, France | | | | |
| 9.9.2013 | Intanza | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | |
| 12.9.2013 | Cystagon | Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | Orphan Europe S.A.R.L. | Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
| Orphan Europe S.A.R.L. | | | | |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | | | | |
| 12.9.2013 | Puregon | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 19.9.2013 | Elaprase | Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, SE-182 33 Danderyd, Sverige |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, SE-182 33 Danderyd, Sverige | | | | |
| 19.9.2013 | Elonva | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 19.9.2013 | Insuman | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, Deutschland |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, Deutschland | | | | |
| 19.9.2013 | NexoBrid | MediWound Germany GmbH Eisenstr. 5, D-65428 Ruesselsheim, Deutschland | MediWound Germany GmbH | Eisenstr. 5, D-65428 Ruesselsheim, Deutschland |
| MediWound Germany GmbH | | | | |
| Eisenstr. 5, D-65428 Ruesselsheim, Deutschland | | | | |
| 19.9.2013 | Orgalutran | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 19.9.2013 | PREZISTA | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 19.9.2013 | PREZISTA | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 19.9.2013 | Revolade | GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | GlaxoSmithKline Trading Services Limited | 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland |
| GlaxoSmithKline Trading Services Limited | | | | |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | | | | |
| 19.9.2013 | Savene | Norgine B.V. Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland | Norgine B.V. | Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland |
| Norgine B.V. | | | | |
| Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland | | | | |
| 19.9.2013 | Simponi | Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, NL-2333 CB Leiden, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland | | | | |
| 19.9.2013 | Stelara | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 24.9.2013 | Intanza | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | |
| 24.9.2013 | TOBI Podhaler | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 25.9.2013 | IDflu | Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France | Sanofi Pasteur SA | 2 avenue Pont Pasteur, F-69007 Lyon, France |
| Sanofi Pasteur SA | | | | |
| 2 avenue Pont Pasteur, F-69007 Lyon, France | | | | |
| 25.9.2013 | Multaq | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 25.9.2013 | Resolor | Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland | Shire Pharmaceuticals Ireland Limited | 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |
| Shire Pharmaceuticals Ireland Limited | | | | |
| 5 River Walk, Citywest Business Campus, Dublin 24, Ireland | | | | |
| 25.9.2013 | RoActemra | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |

—   Withdrawal of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------------------- |
| 3.9.2013 | Rasitrio | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |

Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 2 )): 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 |
| --------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ----------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------------------- | ----------------------------------------------- | -------------------- |
| 12.9.2013 | Apoquel | Oclacitinib maleate | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/13/154 | Film-coated tablet |
| Zoetis Belgium S.A. | | | | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | | | | |
| 19.9.2013 | Trifexis | Spinosad / Milbemycin oxime | Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | Eli Lilly and Company Ltd | Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/13/155 | Chewable tablet |
| Eli Lilly and Company Ltd | | | | | | | |
| Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | | | | | | | |

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------- |
| 12.9.2013 | Equip WNV | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 13.9.2013 | Zulvac 8 Bovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 13.9.2013 | Zulvac 8 Ovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 24.9.2013 | Masivet | AB Science S.A. 3 avenue George V, F-75008 Paris, France | AB Science S.A. | 3 avenue George V, F-75008 Paris, France |
| AB Science S.A. | | | | |
| 3 avenue George V, F-75008 Paris, France | | | | |
| 25.9.2013 | Melovem | Dopharma Research B.V.
Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland | EU/2/09/098 | 27.9.2013 |

—   Withdrawal of a marketing authorization (Article 38 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 authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- |
| 19.9.2013 | Netvax | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | |

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 |
| ----------------------------- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK-LONDON E14 4H |

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

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

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