# C_2013380EN.01000101.xml

| 28.12.2013 | EN | Official Journal of the European Union | C 380/1 |
| ---------- | -- | -------------------------------------- | ------- |

---

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

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

2013/C 380/01

—   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 |
| ------------------------------------- | ------------------------------------ | ------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------ | ----------------------------------------------- | -------------------- |
| 11.11.2013 | Levodopa-Carbidopa-Entacapone Sandoz | levodopa / carbidopa / entacapone | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, | FI-02200 Espoo, | Suomi |
| Orion Corporation | | | | | | | |
| Orionintie 1, | | | | | | | |
| FI-02200 Espoo, | | | | | | | |
| Suomi | | | | | | | |
| 13.11.2013 | NovoEight | turoctocog alfa | 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 | | | | | | | |
| 13.11.2013 | Relvar Elllipta | fluticasone furoate/vilanterol trifenatate | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, | Brentford, Middlesex, | TW8 9GS, |
| Glaxo Group Ltd | | | | | | | |
| 980 Great West Road, | | | | | | | |
| Brentford, Middlesex, | | | | | | | |
| TW8 9GS, | | | | | | | |
| United Kingdom | | | | | | | |
| 13.11.2013 | Vitekta | elvitegravir | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge | CB21 6GT, | United Kingdom |
| Gilead Sciences International Limited | | | | | | | |
| Cambridge | | | | | | | |
| CB21 6GT, | | | | | | | |
| United Kingdom | | | | | | | |
| 13.11.2013 | Xofigo | Radium Ra 223 dichloride | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, | Deutschland | EU/1/13/873 |
| Bayer Pharma AG | | | | | | | |
| D-13342 Berlin, | | | | | | | |
| Deutschland | | | | | | | |
| 15.11.2013 | ABILIFY MAINTENA | Aripiprazole | Otsuka Pharmaceutical Europe Ltd. Gallions Wexham Springs, Framewood Road, Wexham, Slough, Berkshire SL3 6PJ, United Kingdom | Otsuka Pharmaceutical Europe Ltd. | Gallions Wexham Springs, | Framewood Road, | Wexham, Slough, |
| Otsuka Pharmaceutical Europe Ltd. | | | | | | | |
| Gallions Wexham Springs, | | | | | | | |
| Framewood Road, | | | | | | | |
| Wexham, Slough, | | | | | | | |
| Berkshire SL3 6PJ, | | | | | | | |
| United Kingdom | | | | | | | |
| 15.11.2013 | Invokana | canagliflozin | 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 | | | | | | | |
| 15.11.2013 | Kadcyla | Trastuzumab emtansine | 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 | | | | | | | |
| 15.11.2013 | Lidocaine/Prilocaine Plethora | lidocaine / prilocaine | Plethora Solutions Limited Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom | Plethora Solutions Limited | Hampden House, | Monument Business Park, | Chalgrove, OX44 7RW |
| Plethora Solutions Limited | | | | | | | |
| Hampden House, | | | | | | | |
| Monument Business Park, | | | | | | | |
| Chalgrove, OX44 7RW | | | | | | | |
| United Kingdom | | | | | | | |
| 20.11.2013 | Intelence | etravirine | 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 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| -------------------- | ----------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 8.11.2013 | Xeljanz | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| 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 |
| ---------------------------------------------------------- | -------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | --------------------------- |
| 11.11.2013 | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 11.11.2013 | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 11.11.2013 | Oprymea | 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 | | | | |
| 11.11.2013 | Rapamune | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.11.2013 | Actos | 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 | | | | |
| 13.11.2013 | Competact | Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | PO Box 88, |
| Takeda Pharma A/S | | | | |
| PO Box 88, | | | | |
| Langebjerg 1, | | | | |
| DK-4000 Roskilde, | | | | |
| Danmark | | | | |
| 13.11.2013 | 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 | | | | |
| 13.11.2013 | Enbrel | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.11.2013 | Filgrastim Hexal | Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | Hexal AG | Industriestrasse 25, |
| Hexal AG | | | | |
| Industriestrasse 25, | | | | |
| D-83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 13.11.2013 | Firmagon | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 København S, Danmark | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11, |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11, | | | | |
| DK-2300 København S, | | | | |
| Danmark | | | | |
| 13.11.2013 | Firmagon | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 København S, Danmark | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11, |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11, | | | | |
| DK-2300 København S, | | | | |
| Danmark | | | | |
| 13.11.2013 | Fycompa | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | Eisai Europe Limited | European Knowledge Centre, |
| Eisai Europe Limited | | | | |
| European Knowledge Centre, | | | | |
| Mosquito Way, | | | | |
| Hatfield, | | | | |
| Herts AL10 9SN, | | | | |
| United Kingdom | | | | |
| 13.11.2013 | Glubrava | 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 | | | | |
| 13.11.2013 | Glustin | 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 | | | | |
| 13.11.2013 | Invirase | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 13.11.2013 | Jakavi | 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 | | | | |
| 13.11.2013 | Kuvan | 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 | | | | |
| 13.11.2013 | Ranexa | Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | Menarini International Operations Luxembourg S.A. | 1 avenue de la Gare, |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1 avenue de la Gare, | | | | |
| L-1611 Luxembourg, | | | | |
| Grand-Duché de Luxembourg | | | | |
| 13.11.2013 | Rasilez HCT | 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 | | | | |
| 13.11.2013 | ReFacto AF | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.11.2013 | Revlimid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, | | | | |
| Stockley Park, | | | | |
| Uxbridge, | | | | |
| Middlesex UB11 1DB, | | | | |
| United Kingdom | | | | |
| 13.11.2013 | Silodyx | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | Recordati Ireland Ltd. | Raheens East, |
| Recordati Ireland Ltd. | | | | |
| Raheens East, | | | | |
| Ringaskiddy Co. Cork, | | | | |
| Ireland | | | | |
| 13.11.2013 | Tandemact | 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 | | | | |
| 13.11.2013 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | Servier (Ireland) Industries Limited | Gorey Road, |
| Servier (Ireland) Industries Limited | | | | |
| Gorey Road, | | | | |
| Arklow, | | | | |
| Co. Wicklow, | | | | |
| Ireland | | | | |
| 13.11.2013 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | Servier (Ireland) Industries Limited | Gorey Road, |
| Servier (Ireland) Industries Limited | | | | |
| Gorey Road, | | | | |
| Arklow, | | | | |
| Co. Wicklow, | | | | |
| Ireland | | | | |
| 13.11.2013 | Urorec | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | Recordati Ireland Ltd. | Raheens East, |
| Recordati Ireland Ltd. | | | | |
| Raheens East, | | | | |
| Ringaskiddy Co. Cork, | | | | |
| Ireland | | | | |
| 13.11.2013 | Valdoxan | 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 | | | | |
| 13.11.2013 | Valdoxan | 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 | | | | |
| 13.11.2013 | Vidaza | Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, |
| Celgene Europe Limited | | | | |
| Riverside House, | | | | |
| Riverside Walk, | | | | |
| Windsor, | | | | |
| Berkshire SL4 1NA, | | | | |
| United Kingdom | | | | |
| 13.11.2013 | Zarzio | Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich | Sandoz GmbH | Biochemiestrasse 10, |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, | | | | |
| A-6250 Kundl, | | | | |
| Österreich | | | | |
| 15.11.2013 | Alimta | 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 | | | | |
| 15.11.2013 | Azilect | Teva Pharma GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | Teva Pharma GmbH | Graf-Arco-Straße 3, |
| Teva Pharma GmbH | | | | |
| Graf-Arco-Straße 3, | | | | |
| D-89079 Ulm, | | | | |
| Deutschland | | | | |
| 15.11.2013 | Bretaris Genuair | 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 | | | | |
| 15.11.2013 | Ecansya | 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 | | | | |
| 15.11.2013 | Eklira Genuair | 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 | | | | |
| 15.11.2013 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/Pfizer EEIG | Bristol-Myers Squibb House, |
| Bristol-Myers Squibb/Pfizer EEIG | | | | |
| Bristol-Myers Squibb House, | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge, | | | | |
| Middlesex UB8 1DH, | | | | |
| United Kingdom | | | | |
| 15.11.2013 | Kineret | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum AB (publ) | SE-112 76, |
| Swedish Orphan Biovitrum AB (publ) | | | | |
| SE-112 76, | | | | |
| Stockholm, | | | | |
| Sverige | | | | |
| 15.11.2013 | Multaq | 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 | | | | |
| 15.11.2013 | Neulasta | 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 | | | | |
| 15.11.2013 | PREZISTA | 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 | | | | |
| 15.11.2013 | Rapiscan | Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom | Rapidscan Pharma Solutions EU Ltd. | Regent's Place, |
| Rapidscan Pharma Solutions EU Ltd. | | | | |
| Regent's Place, | | | | |
| 338 Euston Road, | | | | |
| London NW1 3BT, | | | | |
| United Kingdom | | | | |
| 15.11.2013 | Sutent | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 15.11.2013 | Tygacil | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 15.11.2013 | Votubia | 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 | | | | |
| 20.11.2013 | 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, |
| The Medicines Company UK Ltd | | | | |
| 115 L Milton Park, | | | | |
| Abingdon, | | | | |
| Oxfordshire OX14 4SA, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | Beromun | 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 | | | | |
| 20.11.2013 | Evicel | Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België | Omrix Biopharmaceuticals N.V. | Leonardo Da Vincilaan 15, |
| Omrix Biopharmaceuticals N.V. | | | | |
| Leonardo Da Vincilaan 15, | | | | |
| B-1831 Diegem, | | | | |
| België | | | | |
| 20.11.2013 | Fasturtec | 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 | | | | |
| 20.11.2013 | HALAVEN | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | Eisai Europe Limited | European Knowledge Centre, |
| Eisai Europe Limited | | | | |
| European Knowledge Centre, | | | | |
| Mosquito Way, | | | | |
| Hatfield, | | | | |
| Herts AL10 9SN, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | Hycamtin | SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | SmithKline Beecham Ltd. | 980 Great West Road, |
| SmithKline Beecham Ltd. | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex TW8 9GS, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | Kalydeco | Vertex Pharmaceuticals (U.K.) Limited Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom | Vertex Pharmaceuticals (U.K.) Limited | Cardinal Point, |
| Vertex Pharmaceuticals (U.K.) Limited | | | | |
| Cardinal Point, | | | | |
| Park Road, | | | | |
| Rickmansworth, | | | | |
| Herts WD3 1RE, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | Mabthera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | Opgenra | Olympus Biotech International Limited Raheen Business Park, Limerick, Ireland | Olympus Biotech International Limited | Raheen Business Park, |
| Olympus Biotech International Limited | | | | |
| Raheen Business Park, | | | | |
| Limerick, | | | | |
| Ireland | | | | |
| 20.11.2013 | Plenadren | ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | ViroPharma SPRL-BVBA | rue Montoyer 47, |
| ViroPharma SPRL-BVBA | | | | |
| rue Montoyer 47, | | | | |
| 1000 Bruxelles, | | | | |
| Belgique / Montoyerstraat 47, | | | | |
| 1000 Brussel, | | | | |
| België | | | | |
| 20.11.2013 | Prevenar 13 | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | Rotarix | 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 | | | | |
| 20.11.2013 | Telzir | 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 | | | | |
| 20.11.2013 | Torisel | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | Zoledronic acid Teva Pharma | 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 | | | | |
| 25.11.2013 | Cimzia | UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | UCB Pharma S.A. | Allée de la Recherche 60, |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/Researchdreef 60, | | | | |
| 1070 Brussel, | | | | |
| België | | | | |
| 25.11.2013 | Elaprase | Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, | | | | |
| SE-182 33 Danderyd, | | | | |
| Sverige | | | | |
| 25.11.2013 | GILENYA | 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 | | | | |
| 25.11.2013 | Pandemic influenza vaccine H5N1 BAXTER | Baxter AG Industriestraße 67, A-1221 Wien, Österreich | Baxter AG | Industriestraße 67, |
| Baxter AG | | | | |
| Industriestraße 67, | | | | |
| A-1221 Wien, | | | | |
| Österreich | | | | |
| 25.11.2013 | Reyataz | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge UB8 1DH, | | | | |
| United Kingdom | | | | |
| 25.11.2013 | 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 | | | | |
| 25.11.2013 | Vepacel | Baxter Innovations GmbH Industriestraße 67, A-1221 Wien, Österreich | Baxter Innovations GmbH | Industriestraße 67, |
| Baxter Innovations GmbH | | | | |
| Industriestraße 67, | | | | |
| A-1221 Wien, | | | | |
| Österreich | | | | |
| 28.11.2013 | Jalra | 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 | | | | |
| 28.11.2013 | Xiliarx | 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 | | | | |
| 29.11.2013 | Arixtra | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, | | | | |
| Brentford, Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 29.11.2013 | Busilvex | Pierre Fabre Médicament 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France | Pierre Fabre Médicament | 45 place Abel Gance, |
| Pierre Fabre Médicament | | | | |
| 45 place Abel Gance, | | | | |
| F-92654 Boulogne-Billancourt CEDEX, | | | | |
| France | | | | |
| 29.11.2013 | Eviplera | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT, |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT, | | | | |
| United Kingdom | | | | |
| 29.11.2013 | Preotact | NPS Pharma Holdings Limited Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland | NPS Pharma Holdings Limited | Grand Canal House, |
| NPS Pharma Holdings Limited | | | | |
| Grand Canal House, | | | | |
| 1 Grand Canal Street Upper, | | | | |
| Dublin 4, | | | | |
| Ireland | | | | |
| 29.11.2013 | Prevenar | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 29.11.2013 | Xeloda | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ------------------------------ | ----------------------------- | -------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------ |
| 8.11.2013 | Onsior | Novartis Animal Health UK Ltd Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom | Novartis Animal Health UK Ltd | Frimley Business Park, |
| Novartis Animal Health UK Ltd | | | | |
| Frimley Business Park, | | | | |
| Frimley/Camberley, | | | | |
| Surrey, | | | | |
| GU16 7SR, | | | | |
| United Kingdom | | | | |
| 8.11.2013 | Zulvac 1+8 Bovis | 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 | | | | |
| 11.11.2013 | Easotic | 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 | | | | |
| 13.11.2013 | Comfortis | Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | Eli Lilly and Company Ltd | Priestley Road, |
| Eli Lilly and Company Ltd | | | | |
| Priestley Road, | | | | |
| Basingstoke, | | | | |
| Hampshire RG24 9NL, | | | | |
| United Kingdom | | | | |
| 20.11.2013 | CERTIFECT | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, |
| Merial | | | | |
| 29 avenue Tony Garnier, | | | | |
| F-69007 Lyon, | | | | |
| 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.

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