# C_2012224EN.01000101.xml

| 27.7.2012 | EN | Official Journal of the European Union | C 224/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012

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

2012/C 224/01

—   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 |
| ---------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | ------------------- | ----------------------------------------------- | -------------------- |
| 15.06.2012 | Rienso | Ferumoxytol | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, | London WC2B 4AE, | United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | | | | |
| 61 Aldwych, | | | | | | | |
| London WC2B 4AE, | | | | | | | |
| United Kingdom | | | | | | | |

—   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 |
| ------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | -------------------- |
| 21.06.2012 | Folotyn | Allos Therapeutics Limited 71 Knowl Piece, Wilbury Way, Hitchin, Hertfordshire SG4 0TY, United Kingdom | Allos Therapeutics Limited | 71 Knowl Piece, |
| Allos Therapeutics Limited | | | | |
| 71 Knowl Piece, | | | | |
| Wilbury Way, | | | | |
| Hitchin, Hertfordshire SG4 0TY, | | | | |
| 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 |
| --------------------------------------------- | ------------------------------------ | ------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | -------------------------------------- |
| 01.06.2012 | Osigraft | 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 | | | | |
| 11.06.2012 | Levetiracetam Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 11.06.2012 | Mycophenolate mofetil Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| DR Utrecht 3542, | | | | |
| Nederland | | | | |
| 11.06.2012 | Myfenax | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| DR Utrecht 3542, | | | | |
| Nederland | | | | |
| 14.06.2012 | Nivestim | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited Queensway, | Royal Leamington Spa, |
| Hospira UK Limited Queensway, | | | | |
| Royal Leamington Spa, | | | | |
| Warwickshire CV31 3RW, | | | | |
| United Kingdom | | | | |
| 14.06.2012 | Quadramet | CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette - France | CIS bio international Boite Postale | 32 - F-91192 Gif-sur-Yvette - |
| CIS bio international Boite Postale | | | | |
| 32 - F-91192 Gif-sur-Yvette - | | | | |
| France | | | | |
| 15.06.2012 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37, |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37, | | | | |
| D-58638 Iserlohn, | | | | |
| Deutschland | | | | |
| 15.06.2012 | Azopt | Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Pentagon Park, |
| Alcon Laboratories (UK) Ltd. | | | | |
| Pentagon Park, | | | | |
| Boundary Way, | | | | |
| Hemel Hempstead, | | | | |
| Herts HP2 7UD, | | | | |
| United Kingdom | | | | |
| 15.06.2012 | Epivir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 15.06.2012 | Evra | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV Turnhoutseweg, | 30 - 2340 Beerse - |
| Janssen-Cilag International NV Turnhoutseweg, | | | | |
| 30 - 2340 Beerse - | | | | |
| België | | | | |
| 15.06.2012 | Optimark | Covidien Deutschland GmbH Gewerbepark 1, Neustadt/Donau 93333, Deutschland | Covidien Deutschland GmbH | Gewerbepark 1, |
| Covidien Deutschland GmbH | | | | |
| Gewerbepark 1, | | | | |
| Neustadt/Donau 93333, | | | | |
| Deutschland | | | | |
| 15.06.2012 | Prevenar | Wyeth-Lederle Vaccines S.A. Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium | Wyeth-Lederle Vaccines S.A. | Pleainlaan 17 Boulevard de la Plaine, |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Pleainlaan 17 Boulevard de la Plaine, | | | | |
| 1050 Brussels - Bruxelles, | | | | |
| Belgium | | | | |
| 15.06.2012 | Temozolomide HEXAL | HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | HEXAL AG | Industriestrasse 25, |
| HEXAL AG | | | | |
| Industriestrasse 25, | | | | |
| D-83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 15.06.2012 | Temozolomide Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, | | | | |
| 83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 18.06.2012 | Atriance | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 18.06.2012 | Binocrit | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | Sandoz GmbH | Biochemiestrasse 10, |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, | | | | |
| Kundl 6250, | | | | |
| Österreich | | | | |
| 18.06.2012 | Epoetin alfa Hexal | Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland | Hexal AG. | Industriestrasse 25, |
| Hexal AG. | | | | |
| Industriestrasse 25, | | | | |
| D-83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 18.06.2012 | GILENYA | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 18.06.2012 | GILENYA | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 18.06.2012 | Soliris | Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France | Alexion Europe S.A.S. | 25, boulevard |
| Alexion Europe S.A.S. | | | | |
| 25, boulevard | | | | |
| de l'Amiral Bruix, | | | | |
| 75016 Paris, | | | | |
| France | | | | |
| 18.06.2012 | Soliris | Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France | Alexion Europe S.A.S. | 25, boulevard |
| Alexion Europe S.A.S. | | | | |
| 25, boulevard | | | | |
| de l'Amiral Bruix, | | | | |
| 75016 Paris, | | | | |
| France | | | | |
| 21.06.2012 | alli | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkeley Avenue, |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, | | | | |
| Greenford, Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 21.06.2012 | Cimzia | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/Researchdreef, | | | | |
| 60, Brussel 1070, | | | | |
| België | | | | |
| 21.06.2012 | Ketek | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92160 Antony, | | | | |
| France | | | | |
| 21.06.2012 | Tarceva | 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 | | | | |
| 21.06.2012 | Yervoy | 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 | | | | |
| 27.06.2012 | Abraxane | 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 | | | | |
| 27.06.2012 | 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 | | | | |
| 27.06.2012 | 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 | | | | |
| 27.06.2012 | Avastin | 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 | | | | |
| 27.06.2012 | Cimzia | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/Researchdreef, | | | | |
| 60, Brussel 1070, | | | | |
| België | | | | |
| 27.06.2012 | Dificlir | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, | | | | |
| 2353 EW Leiderdorp, | | | | |
| Nederland | | | | |
| 27.06.2012 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, | | | | |
| Vanwall Business Park, | | | | |
| Vanwall Road, | | | | |
| Maidenhead, | | | | |
| Berkshire SL6 4XE, | | | | |
| United Kingdom | | | | |
| 27.06.2012 | Insulatard | 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 | | | | |
| 27.06.2012 | Invanz | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 27.06.2012 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - | | | | |
| 2340 Beerse - | | | | |
| België | | | | |
| 27.06.2012 | 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 | | | | |
| 27.06.2012 | Irbesartan HCT Zentiva (Ex-Winthrop) | Sanofi 54, rue La Boétie, 75008 Paris, France | Sanofi | 54, rue La Boétie, |
| Sanofi | | | | |
| 54, rue La Boétie, | | | | |
| 75008 Paris, | | | | |
| France | | | | |
| 27.06.2012 | Javlor | Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France | Pierre Fabre Médicament | 45, place Abel Gance, |
| Pierre Fabre Médicament | | | | |
| 45, place Abel Gance, | | | | |
| F-92100 Boulogne, | | | | |
| France | | | | |
| 27.06.2012 | Karvezide | 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 | | | | |
| 27.06.2012 | Lucentis | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.06.2012 | 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 | | | | |
| 27.06.2012 | 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 | | | | |
| 27.06.2012 | Nexavar | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 27.06.2012 | Osseor | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, | | | | |
| 92284 Suresnes cedex, | | | | |
| France | | | | |
| 27.06.2012 | PREZISTA | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - | | | | |
| 2340 Beerse - | | | | |
| België | | | | |
| 27.06.2012 | Protaphane | 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 | | | | |
| 27.06.2012 | Protelos | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, | | | | |
| 92284 Suresnes cedex, | | | | |
| France | | | | |
| 27.06.2012 | 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 | | | | |
| 27.06.2012 | Revolade | GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | GlaxoSmithKline Trading Services Limited | 6900 Cork Airport Business Park, |
| GlaxoSmithKline Trading Services Limited | | | | |
| 6900 Cork Airport Business Park, | | | | |
| Kinsale Road, | | | | |
| Cork, | | | | |
| Ireland | | | | |
| 27.06.2012 | Stocrin | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 27.06.2012 | Sustiva | 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 | | | | |
| 27.06.2012 | Sycrest | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, 5349 AB Oss, |
| N.V. Organon | | | | |
| Kloosterstraat 6, 5349 AB Oss, | | | | |
| Nederland | | | | |
| 27.06.2012 | Synagis | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, | | | | |
| Vanwall Business Park, | | | | |
| Vanwall Road, | | | | |
| Maidenhead, | | | | |
| Berkshire SL6 4XE, | | | | |
| United Kingdom | | | | |
| 27.06.2012 | Tasigna | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.06.2012 | Temodal | 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 | | | | |
| 27.06.2012 | Trisenox | Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France | Cephalon Europe | 5 Rue Charles Martigny, |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny, | | | | |
| 94700 Maisons Alfort, | | | | |
| Cedex, | | | | |
| France | | | | |
| 27.06.2012 | Viracept | 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 | | | | |
| 27.06.2012 | VPRIV | Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | Shire Pharmaceuticals Ireland Limited | 5 Riverwalk, |
| Shire Pharmaceuticals Ireland Limited | | | | |
| 5 Riverwalk, | | | | |
| Citywest Business Campus, | | | | |
| Dublin 24, | | | | |
| Ireland | | | | |
| 27.06.2012 | 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 | | | | |
| 27.06.2012 | Zeffix | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd. | Greenford Road, |
| Glaxo Group Ltd. | | | | |
| Greenford Road, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 27.06.2012 | Zypadhera | 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 | | | | |
| 27.06.2012 | Zyprexa | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 27.06.2012 | Zyprexa Velotab | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 28.06.2012 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 54, rue La Boétie, 75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54, rue La Boétie, |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54, rue La Boétie, | | | | |
| 75008 Paris, | | | | |
| France | | | | |
| 28.06.2012 | Copalia HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Dafiro HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Ecalta | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | ellaOne | Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France | Laboratoire HRA Pharma | 15, rue Béranger, |
| Laboratoire HRA Pharma | | | | |
| 15, rue Béranger, | | | | |
| 75003 Paris, | | | | |
| France | | | | |
| 28.06.2012 | Exforge | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Firmagon | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, Copenhagen S 2300, Danmark | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11, |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11, | | | | |
| Copenhagen S 2300, | | | | |
| Danmark | | | | |
| 28.06.2012 | GONAL-f | Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Ltd. | 56, Marsh Wall, |
| Merck Serono Europe Ltd. | | | | |
| 56, Marsh Wall, | | | | |
| London E14 9TP, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Icandra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Imprida | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Insulin Human Winthrop | 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 | | | | |
| 28.06.2012 | Jalra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Lamivudine Teva Pharma B.V. | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 28.06.2012 | Myclausen | Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, 14167 Berlin, Deutschland | Herbert J. Passauer GmbH & Co. KG | Stubenrauchstrasse 33, |
| Herbert J. Passauer GmbH & Co. KG | | | | |
| Stubenrauchstrasse 33, | | | | |
| 14167 Berlin, | | | | |
| Deutschland | | | | |
| 28.06.2012 | 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 | | | | |
| 28.06.2012 | PritorPlus | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 28.06.2012 | Rasilez HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Rilonacept Regeneron | Regeneron UK Limited 40 Bank Street, E14 5DS London, United Kingdom | Regeneron UK Limited | 40 Bank Street, |
| Regeneron UK Limited | | | | |
| 40 Bank Street, | | | | |
| E14 5DS London, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Riprazo 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 | | | | |
| 28.06.2012 | Siklos | ADDMEDICA 101, rue Saint Lazare, Paris 75009, France | ADDMEDICA | 101, rue Saint Lazare, |
| ADDMEDICA | | | | |
| 101, rue Saint Lazare, | | | | |
| Paris 75009, | | | | |
| France | | | | |
| 28.06.2012 | Siklos | ADDMEDICA 101, rue Saint Lazare, Paris 75009, France | ADDMEDICA | 101, rue Saint Lazare, |
| ADDMEDICA | | | | |
| 101, rue Saint Lazare, | | | | |
| Paris 75009, | | | | |
| France | | | | |
| 28.06.2012 | Sprimeo 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 | | | | |
| 28.06.2012 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | 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 | | | | |
| 28.06.2012 | 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 | | | | |
| 28.06.2012 | Vyndaqel | Pfizer Specialty UK Limited Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Specialty UK Limited | Ramsgate Road, |
| Pfizer Specialty UK Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Xiliarx | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, RH12 5AB, | | | | |
| United Kingdom | | | | |
| 28.06.2012 | Zomarist | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| 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 |
| -------------------- | ----------------------------- | --------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 28.06.2012 | Hexavac | Aventis Pasteur MSD 8, rue Jonas Salk, 69007 Lyon, France | Aventis Pasteur MSD | 8, rue Jonas Salk, |
| Aventis Pasteur MSD | | | | |
| 8, rue Jonas Salk, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 2 )
): Accepted

| Date of the Décision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | ----------------------- | ----------------------------------------------- | -------------------- |
| 14.06.2012 | Porcilis ColiClos | — | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, | 5831 AN Boxmeer, | Nederland |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35, | | | | | | | |
| 5831 AN Boxmeer, | | | | | | | |
| Nederland | | | | | | | |
| 15.06.2012 | Poulvac E. coli | — | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, | Sandwich, Kent, | CT13 9NJ, |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, | | | | | | | |
| Sandwich, Kent, | | | | | | | |
| CT13 9NJ, | | | | | | | |
| 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 |
| --------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | ----------------------- |
| 11.06.2012 | Activyl | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, | | | | |
| 5831 AN Boxmeer, | | | | |
| Nederland | | | | |
| 14.06.2012 | Emdocam | Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe | Emdoka bvba | J. Lijsenstraat 16, |
| Emdoka bvba | | | | |
| J. Lijsenstraat 16, | | | | |
| B-2321 Hoogstraten, | | | | |
| Belgïe | | | | |
| 27.06.2012 | Bovilis BTV8 | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, | | | | |
| 5831 AN Boxmeer, | | | | |
| Nederland | | | | |
| 28.06.2012 | Nobilis IB 4-91 | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, | | | | |
| 5831 AN Boxmeer, | | | | |
| Nederland | | | | |
| 28.06.2012 | Oxyglobin | OPK Biotech Netherlands BV Teleportboulevard 140, 1043EJ Amsterdam, Nederland | OPK Biotech Netherlands BV | Teleportboulevard 140, |
| OPK Biotech Netherlands BV | | | | |
| Teleportboulevard 140, | | | | |
| 1043EJ Amsterdam, | | | | |
| Nederland | | | | |

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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