# C_2014091EN.01000201.xml

| 28.3.2014 | EN | Official Journal of the European Union | C 91/2 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014

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

2014/C 91/02

—   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 |
| ------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------------- | ----------------------------------------------- | -------------------- |
| 20.2.2014 | Izba | travoprost | 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 | | | | | | | |
| 20.2.2014 | Neuraceq | florbetaben (18F) | Piramal Imaging GmbH Tegeler Strasse 6-7 13353 Berlin – Deutschland | Piramal Imaging GmbH | Tegeler Strasse 6-7 | 13353 Berlin – Deutschland | EU/1/13/906 |
| Piramal Imaging GmbH | | | | | | | |
| Tegeler Strasse 6-7 | | | | | | | |
| 13353 Berlin – Deutschland | | | | | | | |
| 21.2.2014 | Mirvaso | brimonidine | Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | Galderma International | Tour Europlaza, | 20 avenue André Prothin, | La Défense 4, |
| Galderma International | | | | | | | |
| Tour Europlaza, | | | | | | | |
| 20 avenue André Prothin, | | | | | | | |
| La Défense 4, | | | | | | | |
| La Défense Cedex 92927, | | | | | | | |
| France | | | | | | | |

—   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 |
| ----------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | ---------------------------------------------------- |
| 6.2.2014 | Cystadane | 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, |
| Orphan Europe S.A.R.L. | | | | |
| Immeuble Le Wilson, | | | | |
| 70 avenue du Général de Gaulle, | | | | |
| F-92 800 Puteaux, | | | | |
| France | | | | |
| 6.2.2014 | Humira | AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd | Maidenhead, |
| AbbVie Ltd | | | | |
| Maidenhead, | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 6.2.2014 | Repso | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| NL-3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 6.2.2014 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92165 Antony CEDEX, | | | | |
| France | | | | |
| 11.2.2014 | Pravafenix | 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, |
| LABORATOIRES SMB SA | | | | |
| 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, | | | | |
| 1080 Brussel/Bruxelles, | | | | |
| Belgique/België | | | | |
| 11.2.2014 | Sycrest | Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland | Organon N.V. | Kloosterstraat 6, |
| Organon N.V. | | | | |
| Kloosterstraat 6, | | | | |
| NL-5349 AB Oss, | | | | |
| Nederland | | | | |
| 11.2.2014 | Temozolomide Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| NL-3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 12.2.2014 | Mozobil | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| NL-1411 DD Naarden, | | | | |
| Nederland | | | | |
| 13.2.2014 | Lyrica | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 17.2.2014 | Conbriza | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 17.2.2014 | Modigraf | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, | | | | |
| NL-2333 BE Leiden, | | | | |
| Nederland | | | | |
| 17.2.2014 | Victrelis | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.2.2014 | Betmiga | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, | | | | |
| NL-2333 BE Leiden, | | | | |
| Nederland | | | | |
| 20.2.2014 | Bosulif | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 20.2.2014 | Capecitabine Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, 319 Pinner Road, |
| Accord Healthcare Limited | | | | |
| Sage House, 319 Pinner Road, | | | | |
| North Harrow, | | | | |
| Middlesex, HA1 4HF, | | | | |
| United Kingdom | | | | |
| 20.2.2014 | Capecitabine Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| NL-3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 20.2.2014 | Constella | Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, |
| Almirall, S.A. | | | | |
| Ronda General Mitre, 151, | | | | |
| E-08022 Barcelona, | | | | |
| España | | | | |
| 20.2.2014 | Helixate NexGen | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.2.2014 | KOGENATE Bayer | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.2.2014 | Metalyse | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Straße 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 20.2.2014 | Mycamine | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, | | | | |
| NL-2333 BE Leiden, | | | | |
| Nederland | | | | |
| 20.2.2014 | Nevirapine Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| NL-3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 20.2.2014 | Zoledronic acid Actavis | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegur 76-78, | | | | |
| 220 Hafnarfjörður, | | | | |
| Iceland | | | | |
| 20.2.2014 | Zoledronic acid Mylan | Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, |
| Mylan S.A.S | | | | |
| 117 allée des Parcs, | | | | |
| F-69800 Saint Priest, | | | | |
| France | | | | |
| 21.2.2014 | Celsentri | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex TW8 9GS, | | | | |
| United Kingdom | | | | |
| 21.2.2014 | CONTROLOC Control | Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Straße 2, |
| Takeda GmbH | | | | |
| Byk-Gulden-Straße 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 21.2.2014 | Fertavid | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 21.2.2014 | NeuroBloc | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, |
| Eisai Limited | | | | |
| European Knowledge Centre, | | | | |
| Mosquito Way, Hatfield, | | | | |
| Hertfordshire AL10 9SN, | | | | |
| United Kingdom | | | | |
| 21.2.2014 | NovoThirteen | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 21.2.2014 | PANTECTA Control | Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Straße 2, |
| Takeda GmbH | | | | |
| Byk-Gulden-Straße 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 21.2.2014 | PANTOLOC Control | Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Straße 2, |
| Takeda GmbH | | | | |
| Byk-Gulden-Straße 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 21.2.2014 | PANTOZOL Control | Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Straße 2, |
| Takeda GmbH | | | | |
| Byk-Gulden-Straße 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 21.2.2014 | SOMAC Control | Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Straße 2, |
| Takeda GmbH | | | | |
| Byk-Gulden-Straße 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 21.2.2014 | Stelara | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, | | | | |
| B-2340 Beerse, | | | | |
| België | | | | |
| 21.2.2014 | Synflorix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 21.2.2014 | Vectibix | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, |
| Amgen Europe B.V. | | | | |
| Minervum 7061, | | | | |
| NL-4817 ZK Breda, | | | | |
| Nederland | | | | |
| 28.2.2014 | Adjupanrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 28.2.2014 | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Theaterstr. 6, |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | |
| Theaterstr. 6, | | | | |
| D-22880 Wedel, | | | | |
| Deutschland | | | | |
| 28.2.2014 | Effentora | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| NL-3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 28.2.2014 | Instanyl | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, | | | | |
| DK-4000 Roskilde, | | | | |
| Danmark | | | | |
| 28.2.2014 | Ixiaro | Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich | Valneva Austria GmbH | Campus Vienna Biocenter 3, |
| Valneva Austria GmbH | | | | |
| Campus Vienna Biocenter 3, | | | | |
| A-1030 Wien, | | | | |
| Österreich | | | | |
| 28.2.2014 | Menveo | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina, 1, | | | | |
| 53100 Siena, | | | | |
| Italia | | | | |
| 28.2.2014 | Mirapexin | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Straße 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 28.2.2014 | PecFent | Archimedes Development Ltd Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom | Archimedes Development Ltd | Albert Einstein Centre, |
| Archimedes Development Ltd | | | | |
| Albert Einstein Centre, | | | | |
| Nottingham Science and Technology Park, | | | | |
| University Boulevard NG7 2 TN Nottingham, | | | | |
| United Kingdom | | | | |
| 28.2.2014 | Prepandrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 28.2.2014 | Pumarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 28.2.2014 | Rebif | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, | | | | |
| London E14 9TP, | | | | |
| United Kingdom | | | | |
| 28.2.2014 | Samsca | Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | Otsuka Pharmaceutical Europe Ltd. | Gallions, Wexham Springs, |
| Otsuka Pharmaceutical Europe Ltd. | | | | |
| Gallions, Wexham Springs, | | | | |
| Framewood Road, | | | | |
| Wexham, SL3 6PJ, | | | | |
| United Kingdom | | | | |
| 28.2.2014 | Sifrol | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Straße 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 28.2.2014 | Temozolomide Hospira | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, |
| Hospira UK Limited | | | | |
| Queensway, | | | | |
| Royal Leamington Spa, | | | | |
| Warwickshire CV31 3RW, | | | | |
| United Kingdom | | | | |
| 28.2.2014 | Xolair | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| 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 |
| --------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 17.2.2014 | Onduarp | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Straße 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |

—   Lift of suspension of a marketing authorization (Article 20 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 |
| ---------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 21.2.2014 | Luminity | Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom | Lantheus MI UK Limited | Festival House, |
| Lantheus MI UK Limited | | | | |
| Festival House, | | | | |
| 39 Oxford Street, | | | | |
| Newbury, | | | | |
| Berkshire RG14 1JG, | | | | |
| 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 |
| --------------------------- | ----------------------------- | ---------------------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- | ----------------------------------------------- | -------------------- |
| 11.2.2014 | Bravecto | Fluralaner | 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 | | | | | | | |
| 11.2.2014 | NexGard | afoxolaner | 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 | | | | | | | |

—   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 |
| --------------------------------- | ----------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------ |
| 6.2.2014 | Melovem | Dopharma Research B.V. Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland | Dopharma Research B.V. | Zalmweg 24, |
| Dopharma Research B.V. | | | | |
| Zalmweg 24, | | | | |
| NL-4941 VX Raamsdonksveer, | | | | |
| Nederland | | | | |
| 10.2.2014 | Startvac | Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España | Laboratorios Hipra, S.A. | Avda. La Selva, 135, |
| Laboratorios Hipra, S.A. | | | | |
| Avda. La Selva, 135, | | | | |
| E-17170- Amer (Girona), | | | | |
| España | | | | |
| 13.2.2014 | Contacera | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, | | | | |
| 1348 Louvain-La-Neuve, | | | | |
| Belgique | | | | |
| 13.2.2014 | Melosus | CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland | CP-Pharma Handelsgesellschaft mbH | Ostlandring 13, |
| CP-Pharma Handelsgesellschaft mbH | | | | |
| Ostlandring 13, | | | | |
| D-31303 Burgdorf, | | | | |
| Deutschland | | | | |
| 20.2.2014 | CaniLeish | VIRBAC S.A. 1ère Avenue - 2065 m - L.I.D., F-06516 Carros CEDEX, France | VIRBAC S.A. | 1ère Avenue - 2065 m - L.I.D., |
| VIRBAC S.A. | | | | |
| 1ère Avenue - 2065 m - L.I.D., | | | | |
| F-06516 Carros CEDEX, | | | | |
| France | | | | |

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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