# C_2014029EN.01000101.xml

| 31.1.2014 | EN | Official Journal of the European Union | C 29/1 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013

(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 29/01

—   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 |
| ------------------------------ | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------- | ----------------------------------------------- | -------------------- |
| 4.12.2013 | Fluenz Tetra | Influenza Virus Type A, H1N1 / Influenza Virus Type A, H3N2 / Influenza Virus Type B (Victoria lineage) / Influenza Virus, Type B (Yamagata lineage) | MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | MedImmune, LLC | Lagelandseweg 78, | NL-6545 CG Nijmegen, | Nederland |
| MedImmune, LLC | | | | | | | |
| Lagelandseweg 78, | | | | | | | |
| NL-6545 CG Nijmegen, | | | | | | | |
| Nederland | | | | | | | |
| 4.12.2013 | Memantine Accord | memantine | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, | 319 Pinner Road, North Harrow, | Middlesex, |
| Accord Healthcare Limited | | | | | | | |
| Sage House, | | | | | | | |
| 319 Pinner Road, North Harrow, | | | | | | | |
| Middlesex, | | | | | | | |
| HA1 4HF, | | | | | | | |
| United Kingdom | | | | | | | |
| 18.12.2013 | Brintellix | vortioxetine | H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark | H. Lundbeck A/S | Ottiliavej 9, | DK-2500 Valby, | Danmark |
| H. Lundbeck A/S | | | | | | | |
| Ottiliavej 9, | | | | | | | |
| DK-2500 Valby, | | | | | | | |
| Danmark | | | | | | | |
| 20.12.2013 | Opsumit | macitentan | Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | Cheswick Tower, 13th floor, | 389 Cheswick High Road, | London |
| Actelion Registration Ltd | | | | | | | |
| Cheswick Tower, 13th floor, | | | | | | | |
| 389 Cheswick High Road, | | | | | | | |
| London | | | | | | | |
| W4 4AL, | | | | | | | |
| 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 |
| --------------------------------------------------------------- | ------------------------------------- | ------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | --------------------------------------------------------------- |
| 3.12.2013 | Abraxane | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, | | | | |
| Uxbridge | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Bondronat | 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, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Cubicin | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Dynastat | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Orencia | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Rasilamlo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Rasilez | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Rasilez HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 3.12.2013 | Xeplion | 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 | | | | |
| 3.12.2013 | Zoledronic acid 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 | | | | |
| 4.12.2013 | Synagis | AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd | Maidenhead, |
| AbbVie Ltd | | | | |
| Maidenhead, | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 4.12.2013 | Tamiflu | 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, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 9.12.2013 | Sildenafil ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, |
| ratiopharm GmbH | | | | |
| Graf-Arco-Straße 3, | | | | |
| D-89079 Ulm, | | | | |
| Deutschland | | | | |
| 13.12.2013 | Dificlir | 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 | | | | |
| 13.12.2013 | Inovelon | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, Herts |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts | | | | |
| AL10 9SN, | | | | |
| United Kingdom | | | | |
| 13.12.2013 | Irbesartan / Hydrochlorothiazide 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 | | | | |
| 13.12.2013 | JEVTANA | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, | | | | |
| F-75008 Paris, | | | | |
| France | | | | |
| 13.12.2013 | Mimpara | 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 | | | | |
| 13.12.2013 | Revatio | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.12.2013 | Temozolomide HEXAL | Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | Hexal AG | Industriestrasse 25, |
| Hexal AG | | | | |
| Industriestrasse 25, | | | | |
| D-83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 13.12.2013 | Tracleer | Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | Cheswick Tower, 13th floor, 389 Cheswick High Road, |
| Actelion Registration Ltd | | | | |
| Cheswick Tower, 13th floor, 389 Cheswick High Road, | | | | |
| London | | | | |
| W4 4AL, | | | | |
| United Kingdom | | | | |
| 17.12.2013 | Benlysta | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 17.12.2013 | 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, |
| InterMune UK Limited | | | | |
| Grove House, 2nd Floor, 248A Marylebone Road, | | | | |
| London | | | | |
| NW1 6JZ, | | | | |
| United Kingdom | | | | |
| 17.12.2013 | Glybera | uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland | uniQure biopharma B.V. | Meibergdreef 61, |
| uniQure biopharma B.V. | | | | |
| Meibergdreef 61, | | | | |
| NL-1105 BA Amsterdam, | | | | |
| Nederland | | | | |
| 17.12.2013 | Isentress | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 17.12.2013 | Ovitrelle | 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 | | | | |
| 18.12.2013 | Actraphane | 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 | | | | |
| 18.12.2013 | Actrapid | 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 | | | | |
| 18.12.2013 | Aflunov | 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 | | | | |
| 18.12.2013 | Aldurazyme | 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 | | | | |
| 18.12.2013 | APTIVUS | 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 | | | | |
| 18.12.2013 | Bonviva | 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, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Bronchitol | Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom | Pharmaxis Pharmaceuticals Limited | The Priory, Stomp Road, Burnham, Buckinghamshire |
| Pharmaxis Pharmaceuticals Limited | | | | |
| The Priory, Stomp Road, Burnham, Buckinghamshire | | | | |
| SL1 7LW, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Buccolam | ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | ViroPharma SPRL-BVBA rue Montoyer 47, | 1000 Bruxelles, Belgique / Montoyerstraat 47, |
| ViroPharma SPRL-BVBA rue Montoyer 47, | | | | |
| 1000 Bruxelles, Belgique / Montoyerstraat 47, | | | | |
| 1000 Brussel, | | | | |
| België | | | | |
| 18.12.2013 | Cervarix | 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 | | | | |
| 18.12.2013 | Corlentor | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, | | | | |
| F-92284 Suresnes CEDEX, | | | | |
| France | | | | |
| 18.12.2013 | Dexdor | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, |
| Orion Corporation | | | | |
| Orionintie 1, | | | | |
| FI-02200 | | | | |
| Espoo, | | | | |
| Suomi | | | | |
| 18.12.2013 | Efient | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| NL-3991 RA Houten, | | | | |
| Nederland | | | | |
| 18.12.2013 | Emend | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Eporatio | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, |
| ratiopharm GmbH | | | | |
| Graf-Arco-Straße 3, | | | | |
| D-89079 Ulm, | | | | |
| Deutschland | | | | |
| 18.12.2013 | Erbitux | Merck KGaA 64271 Darmstadt | Merck KGaA | 64271 Darmstadt |
| Merck KGaA | | | | |
| 64271 Darmstadt | | | | |
| 18.12.2013 | Esmya | Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország | Gedeon Richter Plc. | Gyömrői út 19-21., |
| Gedeon Richter Plc. | | | | |
| Gyömrői út 19-21., | | | | |
| H-1103 Budapest, | | | | |
| Magyarország | | | | |
| 18.12.2013 | Extavia | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Faslodex | AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | AstraZeneca UK Limited | Alderley Park, Macclesfield, Cheshire, |
| AstraZeneca UK Limited | | | | |
| Alderley Park, Macclesfield, Cheshire, | | | | |
| SK10 4TG | | | | |
| United Kingdom | | | | |
| 18.12.2013 | GILENYA | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Herceptin | 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, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Hizentra | CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | CSL Behring GmbH | Emil-von-Behring-Straße 76, |
| CSL Behring GmbH | | | | |
| Emil-von-Behring-Straße 76, | | | | |
| D-35041 | | | | |
| Marburg, | | | | |
| Deutschland | | | | |
| 18.12.2013 | Incivo | 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 | | | | |
| 18.12.2013 | Kaletra | AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd | Maidenhead, |
| AbbVie Ltd | | | | |
| Maidenhead, | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | Sun Pharmaceutical Industries Europe BV | Polarisavenue 87, |
| Sun Pharmaceutical Industries Europe BV | | | | |
| Polarisavenue 87, | | | | |
| NL-2132 JH | | | | |
| Hoofddorp, | | | | |
| Nederland | | | | |
| 18.12.2013 | Lojuxta | Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | Aegerion Pharmaceuticals Limited | Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge |
| Aegerion Pharmaceuticals Limited | | | | |
| Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge | | | | |
| UB11 1BD, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Luveris | 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 | | | | |
| 18.12.2013 | Mepact | Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France | Takeda France SAS | Immeuble Pacific, |
| Takeda France SAS | | | | |
| Immeuble Pacific, | | | | |
| 11-13 cours Valmy, | | | | |
| 92800 Puteaux, | | | | |
| France | | | | |
| 18.12.2013 | Myozyme | 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 | | | | |
| 18.12.2013 | Nivestim | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire |
| Hospira UK Limited | | | | |
| Queensway, Royal Leamington Spa, Warwickshire | | | | |
| CV31 3RW, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Norvir | AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd | Maidenhead, |
| AbbVie Ltd | | | | |
| Maidenhead, | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | NovoSeven | 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 | | | | |
| 18.12.2013 | Pradaxa | 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 | | | | |
| 18.12.2013 | Procoralan | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, | | | | |
| F-92284 Suresnes CEDEX, | | | | |
| France | | | | |
| 18.12.2013 | ProQuad | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, | | | | |
| F-69007 Lyon, | | | | |
| France | | | | |
| 18.12.2013 | Protopic | 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 | | | | |
| 18.12.2013 | Removab | Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland | Fresenius Biotech GmbH | Am Haag 6-7, |
| Fresenius Biotech GmbH | | | | |
| Am Haag 6-7, | | | | |
| D-82166 Graefelfing, | | | | |
| Deutschland | | | | |
| 18.12.2013 | Repaglinide 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 | | | | |
| 18.12.2013 | Ribavirin Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | Generics [UK] Limited | Station Close, Potters Bar, Hertfordshire, |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, Hertfordshire, | | | | |
| EN6 1TL, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Soliris | Alexion Europe SAS 25 boulevard de l'Amiral Bruix, F-75016 Paris, France | Alexion Europe SAS | 25 boulevard de l'Amiral Bruix, |
| Alexion Europe SAS | | | | |
| 25 boulevard de l'Amiral Bruix, | | | | |
| F-75016 Paris, | | | | |
| France | | | | |
| 18.12.2013 | Temodal | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | VELCADE | 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 | | | | |
| 18.12.2013 | Xeloda | 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, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Xgeva | 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 | | | | |
| 18.12.2013 | Yervoy | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 18.12.2013 | Yondelis | Pharma Mar S.A. Polígono Industrial La Mina, Avda de los Reyes 1, E-28770 Colmenar Viejo, Madrid, España | Pharma Mar S.A. | Polígono Industrial La Mina, |
| Pharma Mar S.A. | | | | |
| Polígono Industrial La Mina, | | | | |
| Avda de los Reyes 1, | | | | |
| E-28770 Colmenar Viejo, Madrid, | | | | |
| España | | | | |
| 18.12.2013 | Zelboraf | 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, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | Abraxane | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | Advate | Baxter AG Industriestraße 67, A-1221 Wien, Österreich | Baxter AG | Industriestraße 67, |
| Baxter AG | | | | |
| Industriestraße 67, | | | | |
| A-1221 Wien, | | | | |
| Österreich | | | | |
| 20.12.2013 | Atriance | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | Caprelsa | AstraZeneca AB SE-151 85 Södertälje, Sverige | AstraZeneca AB | SE-151 85 Södertälje, |
| AstraZeneca AB | | | | |
| SE-151 85 Södertälje, | | | | |
| Sverige | | | | |
| 20.12.2013 | Comtan | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | ellaOne | Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France | Laboratoire HRA Pharma | 15 rue Béranger, |
| Laboratoire HRA Pharma | | | | |
| 15 rue Béranger, | | | | |
| F-75003 Paris, | | | | |
| France | | | | |
| 20.12.2013 | Iclusig | ARIAD Pharma Ltd Brooklands Business Park, Wellington Way, Weybridge, KT13 0TT, United Kingdom | ARIAD Pharma Ltd | Brooklands Business Park, Wellington Way, Weybridge, |
| ARIAD Pharma Ltd | | | | |
| Brooklands Business Park, Wellington Way, Weybridge, | | | | |
| KT13 0TT, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | Ivemend | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | Lantus | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, | | | | |
| Deutschland | | | | |
| 20.12.2013 | Lumigan | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, County Mayo, |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, County Mayo, | | | | |
| Ireland | | | | |
| 20.12.2013 | Mixtard | 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 | | | | |
| 20.12.2013 | Nplate | 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 | | | | |
| 20.12.2013 | Optisulin | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, | | | | |
| Deutschland | | | | |
| 20.12.2013 | Pioglitazone Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, 319 Pinner Road, North Harrow, Middlesex, |
| Accord Healthcare Limited | | | | |
| Sage House, 319 Pinner Road, North Harrow, Middlesex, | | | | |
| HA1 4HF, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | Prolia | 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 | | | | |
| 20.12.2013 | Sabervel | Pharmathen S.A. Dervenakion 6, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | Dervenakion 6, |
| Pharmathen S.A. | | | | |
| Dervenakion 6, | | | | |
| 15351 Pallini Attiki, | | | | |
| Ελλάδα | | | | |
| 20.12.2013 | Tasigna | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.12.2013 | Vizarsin | Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | Krka, d. d., Novo mesto | Šmarješka cesta 6, |
| Krka, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, | | | | |
| 8501 Novo mesto, | | | | |
| Slovenija | | | | |
| 20.12.2013 | VPRIV | 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, |
| Shire Pharmaceuticals Ireland Limited | | | | |
| 5 River Walk, Citywest Business Campus, Dublin 24, | | | | |
| Ireland | | | | |
| 20.12.2013 | Xaluprine | Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | Nova Laboratories Limited | Martin House, Gloucester Crescent, Wigston Leicester, |
| Nova Laboratories Limited | | | | |
| Martin House, Gloucester Crescent, Wigston Leicester, | | | | |
| LE18 4YL, | | | | |
| 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 |
| ---------------------------- | ----------------------------- | -------------------------------------------------- | ------------------------------------------------------------------------ | --------------------------------------------- | ---------------------------- | ----------------------------------------------- | -------------------- |
| 4.12.2013 | BROADLINE | Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel | 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 | | | | | | | |
| 4.12.2013 | Vectra 3D | dinotefuran, pyriproxyfen, permethrin | CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, | F-33500 Libourne, | France |
| CEVA SANTE ANIMALE | | | | | | | |
| 10 avenue de la Ballastière, | | | | | | | |
| F-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 |
| ---------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------- |
| 3.12.2013 | Emdocam | Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, België | Emdoka bvba | J. Lijsenstraat 16, |
| Emdoka bvba | | | | |
| J. Lijsenstraat 16, | | | | |
| B-2321 Hoogstraten, | | | | |
| België | | | | |
| 3.12.2013 | Meloxidolor | Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland | Le Vet Beheer B.V. | Wilgenweg 7, |
| Le Vet Beheer B.V. | | | | |
| Wilgenweg 7, | | | | |
| NL-3421 TV Oudewater, | | | | |
| Nederland | | | | |
| 4.12.2013 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road, New Malden, Surrey |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road, New Malden, Surrey | | | | |
| KT3 4QS | | | | |
| United Kingdom | | | | |
| 9.12.2013 | Acticam | Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, België | Ecuphar NV | Legeweg 157-I, |
| Ecuphar NV | | | | |
| Legeweg 157-I, | | | | |
| B-8020 Oostkamp, | | | | |
| België | | | | |
| 13.12.2013 | Porcilis PCV | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, | | | | |
| NL-5831 AN Boxmeer, | | | | |
| Nederland | | | | |
| 13.12.2013 | Prac-Tic | Novartis Sanidad Animal S.L. Calle de la Marina, 206, E-08013 Barcelona, España | Novartis Sanidad Animal S.L. | Calle de la Marina, 206, |
| Novartis Sanidad Animal S.L. | | | | |
| Calle de la Marina, 206, | | | | |
| E-08013 Barcelona, | | | | |
| España | | | | |
| 18.12.2013 | Meloxidyl | CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, |
| CEVA SANTE ANIMALE | | | | |
| 10 avenue de la Ballastière, | | | | |
| F-33500 Libourne, | | | | |
| 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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