# C_2014243EN.01000101.xml

| 25.7.2014 | EN | Official Journal of the European Union | C 243/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014

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

2014/C 243/01

—   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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ------------------------------------------------------------------ | ----------------------------- | ---------------------------------------- | ---------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------ | ----------------------------------------------- | -------------------- |
| 30.6.2014 | Mekinist | trametinib | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/931 | Film-coated tablet |
| Glaxo Group Ltd | | | | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | | | | |

—   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 |
| ---------------------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------------------------------------------------------------------------- |
| 3.6.2014 | Adasuve | Alexza UK Ltd. 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom | Alexza UK Ltd. | 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom |
| Alexza UK Ltd. | | | | |
| 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom | | | | |
| 3.6.2014 | Clopidogrel Krka d.d. | 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 | | | | |
| 3.6.2014 | Docetaxel Mylan | Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, F-69800 Saint Priest, France |
| Mylan S.A.S | | | | |
| 117 allée des Parcs, F-69800 Saint Priest, France | | | | |
| 3.6.2014 | Docetaxel Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 3.6.2014 | Efficib | 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 | | | | |
| 3.6.2014 | Ibandronic acid Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | | | | |
| 3.6.2014 | Janumet | 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 | | | | |
| 3.6.2014 | Kepivance | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum AB (publ) | SE-112 76, Stockholm, Sverige |
| Swedish Orphan Biovitrum AB (publ) | | | | |
| SE-112 76, Stockholm, Sverige | | | | |
| 3.6.2014 | Kiovig | Baxter AG Industriestraße 67, A-1221 Wien, Österreich | Baxter AG | Industriestraße 67, A-1221 Wien, Österreich |
| Baxter AG | | | | |
| Industriestraße 67, A-1221 Wien, Österreich | | | | |
| 3.6.2014 | Lysodren | Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France | Laboratoire HRA Pharma | 15 rue Béranger, F-75003 Paris, France |
| Laboratoire HRA Pharma | | | | |
| 15 rue Béranger, F-75003 Paris, France | | | | |
| 3.6.2014 | Macugen | 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 | | | | |
| 3.6.2014 | Memantine LEK | 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 | | | | |
| 3.6.2014 | Nevanac | Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | Alcon Laboratories (UK) Ltd. | Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | | | | |
| 3.6.2014 | 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 | | | | |
| 3.6.2014 | Prolia | 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 | | | | |
| 3.6.2014 | Ristfor | 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 | | | | |
| 3.6.2014 | Velmetia | 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 | | | | |
| 3.6.2014 | Yondelis | Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | Pharma Mar S.A. | Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |
| Pharma Mar S.A. | | | | |
| Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | | | | |
| 6.6.2014 | Champix | 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 | | | | |
| 6.6.2014 | Edarbi | Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark | Takeda Pharma A/S | Dybendal Alle 10, 2630 Taastrup, Danmark |
| Takeda Pharma A/S | | | | |
| Dybendal Alle 10, 2630 Taastrup, Danmark | | | | |
| 6.6.2014 | Gardasil | Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 162 avenue Jean Jaurès, 69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 162 avenue Jean Jaurès, 69007 Lyon, France | | | | |
| 6.6.2014 | 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 | | | | |
| 6.6.2014 | Silgard | 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 | | | | |
| 6.6.2014 | Telmisartan Teva Pharma | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 6.6.2014 | Topotecan Actavis | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | | | | |
| 6.6.2014 | Zutectra | Biotest Pharma GmbH Landsteinerstrasse 5, D-63303 Dreieich, Deutschland | Biotest Pharma GmbH | Landsteinerstrasse 5, D-63303 Dreieich, Deutschland |
| Biotest Pharma GmbH | | | | |
| Landsteinerstrasse 5, D-63303 Dreieich, Deutschland | | | | |
| 12.6.2014 | Imatinib Actavis | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | | | | |
| 19.6.2014 | 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 | | | | |
| 19.6.2014 | Enurev 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 | | | | |
| 19.6.2014 | Erivedge | 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 | | | | |
| 19.6.2014 | GILENYA | 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 | | | | |
| 19.6.2014 | Ilaris | 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 | | | | |
| 19.6.2014 | Incivo | 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 | | | | |
| 19.6.2014 | Javlor | Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France | Pierre Fabre Médicament | 45, place Abel Gance, F-92100 Boulogne, France |
| Pierre Fabre Médicament | | | | |
| 45, place Abel Gance, F-92100 Boulogne, France | | | | |
| 19.6.2014 | Osseor | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 19.6.2014 | Ozurdex | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, County Mayo, Ireland |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, County Mayo, Ireland | | | | |
| 19.6.2014 | Protelos | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 19.6.2014 | Remicade | 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 | | | | |
| 19.6.2014 | Repaglinide Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 19.6.2014 | Samsca | Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | Otsuka Pharmaceutical Europe Ltd. | Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
| Otsuka Pharmaceutical Europe Ltd. | | | | |
| Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | | | | |
| 19.6.2014 | Seebri 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 | | | | |
| 19.6.2014 | 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 | | | | |
| 19.6.2014 | Topotecan Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 19.6.2014 | Tovanor 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 | | | | |
| 19.6.2014 | Valdoxan | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 19.6.2014 | 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 | | | | |
| 23.6.2014 | Angiox | The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | The Medicines Company UK Ltd | 115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom |
| The Medicines Company UK Ltd | | | | |
| 115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | | | | |
| 23.6.2014 | Bosulif | 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 | | | | |
| 23.6.2014 | Brilique | AstraZeneca AB SE-151 85 Södertälje, Sverige | AstraZeneca AB | SE-151 85 Södertälje, Sverige |
| AstraZeneca AB | | | | |
| SE-151 85 Södertälje, Sverige | | | | |
| 23.6.2014 | Diacomit | Biocodex 7 avenue Gallieni, F-94250 Gentilly, France | Biocodex | 7 avenue Gallieni, F-94250 Gentilly, France |
| Biocodex | | | | |
| 7 avenue Gallieni, F-94250 Gentilly, France | | | | |
| 23.6.2014 | Prevenar 13 | 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 | | | | |
| 23.6.2014 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | Servier (Ireland) Industries Limited | Gorey Road, Arklow, Co. Wicklow, Ireland |
| Servier (Ireland) Industries Limited | | | | |
| Gorey Road, Arklow, Co. Wicklow, Ireland | | | | |
| 23.6.2014 | Vfend | 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 | | | | |
| 23.6.2014 | Yondelis | Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | Pharma Mar S.A. | Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |
| Pharma Mar S.A. | | | | |
| Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | | | | |
| 23.6.2014 | Zeffix | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 27.6.2014 | Amyvid | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 27.6.2014 | 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 | | | | |
| 27.6.2014 | Circadin | RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | RAD Neurim Pharmaceuticals EEC Limited | One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | | | | |
| 27.6.2014 | Esbriet | InterMune UK Limited Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom | InterMune UK Limited | Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom |
| InterMune UK Limited | | | | |
| Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom | | | | |
| 27.6.2014 | Foclivia | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, 53100 Siena, Italia |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina, 1, 53100 Siena, Italia | | | | |
| 27.6.2014 | HALAVEN | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | Eisai Europe Limited | European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
| Eisai Europe Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | | | | |
| 27.6.2014 | Ibandronic Acid Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 27.6.2014 | Kineret | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum AB (publ) | SE-112 76, Stockholm, Sverige |
| Swedish Orphan Biovitrum AB (publ) | | | | |
| SE-112 76, Stockholm, Sverige | | | | |
| 27.6.2014 | Orfadin | Swedish Orphan Biovitrum International AB SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum International AB | SE-112 76, Stockholm, Sverige |
| Swedish Orphan Biovitrum International AB | | | | |
| SE-112 76, Stockholm, Sverige | | | | |
| 27.6.2014 | Rasilamlo | 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 | | | | |
| 27.6.2014 | Rasilez | 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 | | | | |
| 27.6.2014 | Rasilez 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 | | | | |
| 27.6.2014 | Topotecan Hospira | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
| Hospira UK Limited | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | |
| 27.6.2014 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | UCB Pharma Ltd. | 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |
| UCB Pharma Ltd. | | | | |
| 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | | | | |
| 27.6.2014 | ZALTRAP | 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 | | | | |
| 27.6.2014 | Zoledronic acid Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 30.6.2014 | Arzerra | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 30.6.2014 | Avastin | 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 | | | | |
| 30.6.2014 | Exforge 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 | | | | |
| 30.6.2014 | Perjeta | 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 | | | | |

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ----------------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------ | --------------------------------------------- | ----------------------------------------------------- | ----------------------------------------------- | -------------------- |
| 6.6.2014 | Vectra Felis | dinotefuran, pyriproxyfen | CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/14/165 | Spot-on solution |
| CEVA SANTE ANIMALE | | | | | | | |
| 10 avenue de la Ballastière, F-33500 Libourne, France | | | | | | | |

—   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 |
| ----------------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------------- |
| 3.6.2014 | Activyl | 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 | | | | |
| 6.6.2014 | Cerenia | 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 | | | | |
| 6.6.2014 | Leucofeligen FeLV/RCP | Virbac 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France | Virbac | 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France |
| Virbac | | | | |
| 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France | | | | |
| 6.6.2014 | Melovem | Dopharma Research B.V. Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland | Dopharma Research B.V. | Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland |
| Dopharma Research B.V. | | | | |
| Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland | | | | |
| 6.6.2014 | Metacam | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 6.6.2014 | Suvaxyn PCV | 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 | | | | |
| 12.6.2014 | Leucogen | Virbac 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France | Virbac | 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France |
| Virbac | | | | |
| 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France | | | | |
| 19.6.2014 | Locatim | Biokema Anstalt Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein | Biokema Anstalt | Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein |
| Biokema Anstalt | | | | |
| Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein | | | | |
| 19.6.2014 | Previcox | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 23.6.2014 | Econor | Novartis Tiergesundheit GmbH Zielstattstrasse 40, D-81379 München, Deutschland | Novartis Tiergesundheit GmbH | Zielstattstrasse 40, D-81379 München, Deutschland |
| Novartis Tiergesundheit GmbH | | | | |
| Zielstattstrasse 40, D-81379 München, Deutschland | | | | |
| 27.6.2014 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España | Laboratorios Hipra, S.A. | Avda. La Selva, 135, E-17170- Amer (Girona), España |
| Laboratorios Hipra, S.A. | | | | |
| Avda. La Selva, 135, E-17170- Amer (Girona), España | | | | |
| 27.6.2014 | 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 | | | | |
| 27.6.2014 | 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 | | | | |
| 30.6.2014 | TruScient | 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 | | | | |

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, 30.4.04, p. 1.

( 2 )  OJ L 136, 30.4.04, p. 1.

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