# C_2012264EN.01000101.xml

| 31.8.2012 | EN | Official Journal of the European Union | C 264/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012

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

2012/C 264/01

—   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 |
| ----------------------------------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | -------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------------------------------------------- | ----------------------------------------------- | -------------------- |
| 20.7.2012 | Bretaris Genuair | aclidinium bromide | Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/12/781/001-003 | Inhalation powder |
| Almirall, S.A. | | | | | | | |
| Ronda General Mitre, 151, 08022 Barcelona, España | | | | | | | |
| 20.7.2012 | Eklira Genuair | aclidinium bromide | Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/12/778/001-003 | Inhalation powder |
| Almirall, S.A. | | | | | | | |
| Ronda General Mitre, 151, 08022 Barcelona, España | | | | | | | |
| 20.7.2012 | Jentadueto | linagliptin/metformin hydrochloride | Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780/001-028 | Film-coated tablet |
| Boehringer Ingelheim International GmbH | | | | | | | |
| Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | | | | | | | |
| 23.7.2012 | Fycompa | Perampanel | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom | Eisai Europe Limited | European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom | EU/1/12/776/001-016 | Film-coated tablet |
| Eisai Europe Limited | | | | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom | | | | | | | |
| 23.7.2012 | Kalydeco | ivacaftor | Vertex Pharmaceuticals (U.K.) Limited 88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom | Vertex Pharmaceuticals (U.K.) Limited | 88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom | EU/1/12/782/001-002 | Film-coated tablet |
| Vertex Pharmaceuticals (U.K.) Limited | | | | | | | |
| 88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom | | | | | | | |

—   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 |
| ------------------------------------------------------------------------------------------------ | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
| 3.7.2012 | 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 | | | | |
| 3.7.2012 | Kinzalkomb | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, Deutschland |
| Bayer Pharma AG | | | | |
| Berlin 13342, Deutschland | | | | |
| 3.7.2012 | MicardisPlus | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 3.7.2012 | Prevenar 13 | Wyeth-Lederle Vaccines S.A. Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique | Wyeth-Lederle Vaccines S.A. | Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique | | | | |
| 4.7.2012 | Arixtra | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd. | Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd. | | | | |
| Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 4.7.2012 | Iasibon | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
| Pharmathen S.A. | | | | |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | | | | |
| 4.7.2012 | Potactasol | Actavis Group PTC ehf. Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland | | | | |
| 6.7.2012 | Ganfort | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 6.7.2012 | Olazax | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | | | | |
| 6.7.2012 | Simulect | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 6.7.2012 | Trizivir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 12.7.2012 | Edarbi | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 12.7.2012 | Ipreziv | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 16.7.2012 | Olanzapine Glenmark | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | | | | |
| 20.7.2012 | Arzerra | Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 20.7.2012 | Avamys | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 20.7.2012 | BeneFIX | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 20.7.2012 | Celsentri | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 20.7.2012 | Cyanokit | Merck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, France | Merck Santé s.a.s. | 37, rue Saint-Romain, 69379 Lyon Cedex 08, France |
| Merck Santé s.a.s. | | | | |
| 37, rue Saint-Romain, 69379 Lyon Cedex 08, France | | | | |
| 20.7.2012 | InductOs | Medtronic Biopharma BV Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland | Medtronic Biopharma BV | Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland |
| Medtronic Biopharma BV | | | | |
| Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland | | | | |
| 20.7.2012 | Intelence | 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 | | | | |
| 23.7.2012 | Afinitor | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.7.2012 | Alimta | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, 3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, 3991 RA Houten, Nederland | | | | |
| 23.7.2012 | Bridion | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, 5349 AB Oss, Nederland |
| N.V. Organon | | | | |
| Kloosterstraat 6, 5349 AB Oss, Nederland | | | | |
| 23.7.2012 | Cayston | Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |
| Gilead Sciences International Limited | | | | |
| Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | | | | |
| 23.7.2012 | Epivir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 23.7.2012 | Eucreas | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.7.2012 | Galvus | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.7.2012 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | | | | |
| 23.7.2012 | Ketek | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, F-92160 Antony, France |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, F-92160 Antony, France | | | | |
| 23.7.2012 | Lumigan | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 23.7.2012 | Oslif Breezhaler | 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 | | | | |
| 26.7.2012 | Celvapan | Baxter AG Industriestraße 67, A-1221 Wien, Österreich | Baxter AG | Industriestraße 67, A-1221 Wien, Österreich |
| Baxter AG | | | | |
| Industriestraße 67, A-1221 Wien, Österreich | | | | |
| 26.7.2012 | Esmya | PregLem France SAS. 32, route de l'Eglise, 74140 Massongy, France | PregLem France SAS. | 32, route de l'Eglise, 74140 Massongy, France |
| PregLem France SAS. | | | | |
| 32, route de l'Eglise, 74140 Massongy, France | | | | |
| 26.7.2012 | Evicel | Omrix Biopharmaceuticals N.V. Leonardo Da Vinci Laan 15, B-1831 Diegem, België | Omrix Biopharmaceuticals N.V. | Leonardo Da Vinci Laan 15, B-1831 Diegem, België |
| Omrix Biopharmaceuticals N.V. | | | | |
| Leonardo Da Vinci Laan 15, B-1831 Diegem, België | | | | |
| 26.7.2012 | Grepid | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
| Pharmathen S.A. | | | | |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | | | | |
| 26.7.2012 | Onbrez Breezhaler | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 26.7.2012 | Pradaxa | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 26.7.2012 | Silapo | STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | STADA Arzneimittel AG | Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland |
| STADA Arzneimittel AG | | | | |
| Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | | | | |
| 26.7.2012 | Votubia | 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 | | | | |
| 26.7.2012 | Zalasta | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d.d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| KRKA, d.d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 31.7.2012 | Enbrel | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 31.7.2012 | Isentress | 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 | | | | |
| 31.7.2012 | NovoRapid | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 31.7.2012 | Tyverb | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 31.7.2012 | Victrelis | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hodderson, Hertfordshire EN11 9BU, 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 |
| ---------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------- |
| 4.7.2012 | Sprimeo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 6.7.2012 | Sprimeo HCT | 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 | | | | |
| 16.7.2012 | Regranex | 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 | | | | |

—   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 Décision | 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 |
| --------------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------- | ----------------------------------------------- | ------------------------ |
| 16.7.2012 | Nobivac L4 | — | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/12/143/001-005 | Suspension for injection |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | | | | | | | |
| 23.7.2012 | Cardalis | Benazepril hydrochloride, Spironolactone | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, 33500 Libourne, France | EU/2/12/142/001-006 | Tablet |
| CEVA SANTE ANIMALE | | | | | | | |
| 10 avenue de la Ballastière, 33500 Libourne, France | | | | | | | |

—   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 |
| ------------------------------------------------------ | ----------------------------- | ------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------ |
| 4.7.2012 | Proteq West Nile | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, 69007 LYON, France |
| MERIAL | | | | |
| 29 avenue Tony Garnier, 69007 LYON, France | | | | |
| 6.7.2012 | Vaxxitek HVT+ IBD | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, 69007 Lyon, France |
| Merial | | | | |
| 29 Avenue Tony Garnier, 69007 Lyon, France | | | | |
| 12.7.2012 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein, Deutschland | | | | |
| 12.7.2012 | Novem | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein, Deutschland | | | | |
| 20.7.2012 | ProMeris | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | | | | |
| 20.7.2012 | ProMeris Duo | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |

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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