# C_2012148EN.01000101.xml

| 25.5.2012 | EN | Official Journal of the European Union | C 148/1 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 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 148/01

—   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 |
| ------------------------------------------ | ----------------------------- | ------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------ | ----------------------------------------------- | -------------------- |
| 13.4.2012 | Bronchitol | Mannitol | Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom | Pharmaxis Pharmaceuticals Limited | The Priory, Stomp Road, Burnham, | Buckinghamshire, | SL1 7LW, |
| Pharmaxis Pharmaceuticals Limited | | | | | | | |
| The Priory, Stomp Road, Burnham, | | | | | | | |
| Buckinghamshire, | | | | | | | |
| SL1 7LW, | | | | | | | |
| United Kingdom | | | | | | | |
| 13.4.2012 | Sabervel | Irbesartan | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, | 15351 Pallini Attiki, | Ελλάδα |
| Pharmathen S.A. | | | | | | | |
| 6 Dervenakion, | | | | | | | |
| 15351 Pallini Attiki, | | | | | | | |
| Ελλάδα | | | | | | | |
| 20.4.2012 | Capecitabine Accord | capecitabine | 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 | HA1 4HF |
| Accord Healthcare Limited | | | | | | | |
| Sage house, 319 Pinner road, North Harrow, | | | | | | | |
| Middlesex | | | | | | | |
| HA1 4HF | | | | | | | |
| United Kingdom | | | | | | | |
| 20.4.2012 | Capecitabine Krka | capecitabine | KRKA, d.d Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia | KRKA, d.d | Novo mesto, Šmarješka cesta 6, | 8501 Novo mesto, | Slovenia |
| KRKA, d.d | | | | | | | |
| Novo mesto, Šmarješka cesta 6, | | | | | | | |
| 8501 Novo mesto, | | | | | | | |
| Slovenia | | | | | | | |
| 20.4.2012 | Capecitabine Teva | capecitabine | TEVA Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | TEVA Pharma B.V. | Computerweg 10, | 3542 DR Utrecht, | Nederland |
| TEVA Pharma B.V. | | | | | | | |
| Computerweg 10, | | | | | | | |
| 3542 DR Utrecht, | | | | | | | |
| Nederland | | | | | | | |
| 20.4.2012 | Nimenrix | Meningococcal group A, C, W-135 and Y conjugate vaccine | GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | Rue de l'Institut 89, | 1330 Rixensart, | Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | | | | |
| Rue de l'Institut 89, | | | | | | | |
| 1330 Rixensart, | | | | | | | |
| Belgique | | | | | | | |
| 20.4.2012 | SANCUSO | granisetron | ProStrakan Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | ProStrakan Limited | Galabank Business Park, | Galashiels, | TD1 1QH, |
| ProStrakan Limited | | | | | | | |
| Galabank Business Park, | | | | | | | |
| Galashiels, | | | | | | | |
| TD1 1QH, | | | | | | | |
| United Kingdom | | | | | | | |
| 20.4.2012 | Zoledronic acid Actavis | zoledronic acid | Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | Actavis Group PTC ehf. | ReykjavÍkurvegur 76-78, | Hafnarfjörður 220, | Iceland |
| Actavis Group PTC ehf. | | | | | | | |
| ReykjavÍkurvegur 76-78, | | | | | | | |
| Hafnarfjörður 220, | | | | | | | |
| Iceland | | | | | | | |
| 24.4.2012 | Signifor | pasireotide | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, | West Sussex, | RH12 5AB, |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, | | | | | | | |
| West Sussex, | | | | | | | |
| RH12 5AB, | | | | | | | |
| 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 |
| -------------------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | -------------------------------------------------------------- |
| 3.4.2012 | Kinzalkomb | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 4.4.2012 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 4.4.2012 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France - |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France - | | | | |
| 75013 Paris, | | | | |
| France | | | | |
| 4.4.2012 | Rebetol | Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België | Schering Plough Europe | Clos du Lynx 5, |
| Schering Plough Europe | | | | |
| Clos du Lynx 5, | | | | |
| 1200 Bruxelles, | | | | |
| Belgique – | | | | |
| Lynx Binnenhof 5, | | | | |
| 1200 Brussel, | | | | |
| België | | | | |
| 4.4.2012 | Telzir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, | | | | |
| Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 10.4.2012 | Vedrop | Orphan Europe SARL Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France | Orphan Europe SARL | Immeuble Le Wilson - |
| Orphan Europe SARL | | | | |
| Immeuble Le Wilson - | | | | |
| 70 Avenue du Général de Gaulle - | | | | |
| F 92 800 Puteaux - | | | | |
| France | | | | |
| 13.4.2012 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, | | | | |
| NL-2353 EW Leiderdorp, | | | | |
| Nederland | | | | |
| 13.4.2012 | alli | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkeley Avenue, Greenford, |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 13.4.2012 | Champix | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.4.2012 | Evoltra | Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland | Genzyme Europe BV | Gooimeer 10, |
| Genzyme Europe BV | | | | |
| Gooimeer 10, | | | | |
| 1411 DD Naarden, | | | | |
| Nederland | | | | |
| 13.4.2012 | Foscan | Biolitec pharma Ltd United Drug House, Magna Drive, Dublin 24, Ireland | Biolitec pharma Ltd | United Drug House, Magna Drive, |
| Biolitec pharma Ltd | | | | |
| United Drug House, Magna Drive, | | | | |
| Dublin 24, | | | | |
| Ireland | | | | |
| 13.4.2012 | 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 | | | | |
| 13.4.2012 | Prometax | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 13.4.2012 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Sandwich, |
| Pfizer Limited | | | | |
| Sandwich, | | | | |
| Kent, | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.4.2012 | Revlimid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, | | | | |
| Middlesex, | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 13.4.2012 | Soliris | Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France | Alexion Europe S.A.S. | 25, boulevard de l'Amiral Bruix, |
| Alexion Europe S.A.S. | | | | |
| 25, boulevard de l'Amiral Bruix, | | | | |
| 75016 Paris, | | | | |
| France | | | | |
| 13.4.2012 | Tyverb | 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 | | | | |
| 13.4.2012 | Viramune | 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 | | | | |
| 13.4.2012 | Volibris | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, |
| Glaxo Group Ltd | | | | |
| Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Abraxane | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, | | | | |
| Middlesex, | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Aclasta | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | 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 | | | | |
| 20.4.2012 | Altargo | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkeley Avenue, Greenford, |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Apidra | 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 | | | | |
| 20.4.2012 | Ceplene | EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland | EpiCept GmbH | Goethestrasse 4, |
| EpiCept GmbH | | | | |
| Goethestrasse 4, | | | | |
| D-80336 München, | | | | |
| Deutschland | | | | |
| 20.4.2012 | Circadin | RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | RAD Neurim Pharmaceuticals EEC Limited | One Forbury Square, The Forbury, Reading, |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| One Forbury Square, The Forbury, Reading, | | | | |
| Berkshire | | | | |
| RG1 3EB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Exelon | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Focetria | 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 | | | | |
| 20.4.2012 | HALAVEN | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | Eisai Europe Limited | European Knowledge Centre, Mosquito Way, Hatfield, |
| Eisai Europe Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, | | | | |
| Herts | | | | |
| AL10 9SN, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Helixate NexGen | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.4.2012 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | 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 | | | | |
| 20.4.2012 | Insuman | 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 | | | | |
| 20.4.2012 | IOA | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, |
| N.V. Organon | | | | |
| Kloosterstraat 6, | | | | |
| 5349 AB Oss, | | | | |
| Nederland | | | | |
| 20.4.2012 | Iressa | AstraZeneca AB S 151 85 Sodertalje, Sverige | AstraZeneca AB | S 151 85 Sodertalje, |
| AstraZeneca AB | | | | |
| S 151 85 Sodertalje, | | | | |
| Sverige | | | | |
| 20.4.2012 | Kogenate Bayer | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.4.2012 | 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 | | | | |
| 20.4.2012 | Norvir | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | NovoNorm | 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 | | | | |
| 20.4.2012 | Opgenra | Olympus Biotech International Limited Raheen Business Park, Limerick, Ireland | Olympus Biotech International Limited | Raheen Business Park, Limerick, |
| Olympus Biotech International Limited | | | | |
| Raheen Business Park, Limerick, | | | | |
| Ireland | | | | |
| 20.4.2012 | Optimark | Covidien Deutschland GmbH Gewerbepark 1, 93333 Neustadt/Donau, Deutschland | Covidien Deutschland GmbH | Gewerbepark 1, |
| Covidien Deutschland GmbH | | | | |
| Gewerbepark 1, | | | | |
| 93333 Neustadt/Donau, | | | | |
| Deutschland | | | | |
| 20.4.2012 | 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 | | | | |
| 20.4.2012 | Pelzont | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Prandin | 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 | | | | |
| 20.4.2012 | Preotact | Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark | Nycomed Danmark ApS | Langebjerg 1, |
| Nycomed Danmark ApS | | | | |
| Langebjerg 1, | | | | |
| DK-4000 Roskilde, | | | | |
| Danmark | | | | |
| 20.4.2012 | 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 | | | | |
| 20.4.2012 | ProQuad | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |
| 20.4.2012 | Rasilamlo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex, | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Rasilez | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Riprazo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Riprazo HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex, | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Samsca | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, | | | | |
| Middlesex | | | | |
| UB8 1LX, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Sebivo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Silodyx | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | Recordati Ireland Ltd. | Raheens East, Ringaskiddy Co. Cork, |
| Recordati Ireland Ltd. | | | | |
| Raheens East, Ringaskiddy Co. Cork, | | | | |
| Ireland | | | | |
| 20.4.2012 | Sprimeo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Sprimeo HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex, | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Tracleer | Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor, 389 Chiswick High Road, |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor, 389 Chiswick High Road, | | | | |
| London | | | | |
| W4 4AL, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Tredaptive | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Trevaclyn | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Urorec | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | Recordati Ireland Ltd. | Raheens East, Ringaskiddy Co. Cork, |
| Recordati Ireland Ltd. | | | | |
| Raheens East, Ringaskiddy Co. Cork, | | | | |
| Ireland | | | | |
| 20.4.2012 | Ventavis | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.4.2012 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Victoza | 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 | | | | |
| 20.4.2012 | Vidaza | Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Ltd | 1 Longwalk Road, Stockley Park, |
| Celgene Europe Ltd | | | | |
| 1 Longwalk Road, Stockley Park, | | | | |
| Uxbridge, | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Xenical | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn | | | | |
| Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | Yttriga | Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Str. 10, 13125 Berlin, Deutschland | Eckert & Ziegler Radiopharma GmbH | Robert-Rössle-Str. 10, |
| Eckert & Ziegler Radiopharma GmbH | | | | |
| Robert-Rössle-Str. 10, | | | | |
| 13125 Berlin, | | | | |
| Deutschland | | | | |
| 20.4.2012 | Zoely | Theramex S.r.l. Via Messina 38, 20154 Milano, Italia | Theramex S.r.l. | Via Messina 38, |
| Theramex S.r.l. | | | | |
| Via Messina 38, | | | | |
| 20154 Milano, | | | | |
| Italia | | | | |
| 24.4.2012 | 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 | | | | |
| 24.4.2012 | Rasilez HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.4.2012 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Fehlandtstrasse 3, |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | |
| Fehlandtstrasse 3, | | | | |
| D-20354 Hamburg - | | | | |
| Deutschland | | | | |
| 26.4.2012 | Revolade | GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | GlaxoSmithKline Trading Services Limited | 6900 Cork Airport Business Park, Kinsale Road, Cork, |
| GlaxoSmithKline Trading Services Limited | | | | |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, | | | | |
| Ireland | | | | |
| 26.4.2012 | Yervoy | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, | | | | |
| Uxbridge | | | | |
| UB8 1DH, | | | | |
| 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 |
| ------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------------------------------------------------------- |
| 20.4.2012 | PhotoBarr | Pinnacle Biologics B.V. p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, Nederland | Pinnacle Biologics B.V. | p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, |
| Pinnacle Biologics B.V. | | | | |
| p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, | | | | |
| 1043 DP Amsterdam, | | | | |
| Nederland | | | | |
| 24.4.2012 | Refludan | Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Ltd | 1 Longwalk Road, Stockley Park, |
| Celgene Europe Ltd | | | | |
| 1 Longwalk Road, Stockley Park, | | | | |
| Uxbridge, | | | | |
| UB11 1DB, | | | | |
| 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 |
| ----------------------------- | ----------------------------- | -------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------ |
| 10.4.2012 | Slentrol | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.4.2012 | Cerenia | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 20.4.2012 | BTVPUR AlSap 1 | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, |
| MERIAL | | | | |
| 29 avenue Tony Garnier, | | | | |
| 69007 LYON, | | | | |
| France | | | | |
| 20.4.2012 | BTVPUR AlSap 1-8 | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, |
| MERIAL | | | | |
| 29 avenue Tony Garnier, | | | | |
| 69007 LYON, | | | | |
| France | | | | |
| 20.4.2012 | Loxicom | Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | Norbrook Laboratories Limited | Station Works, Newry, |
| Norbrook Laboratories Limited | | | | |
| Station Works, Newry, | | | | |
| Co. Down, | | | | |
| BT35 6JP, | | | | |
| United Kindgom | | | | |
| 20.4.2012 | Meloxivet | Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België | Janssen Pharmaceutica N.V. | Turnhoutseweg 30, |
| Janssen Pharmaceutica N.V. | | | | |
| Turnhoutseweg 30, | | | | |
| B-2340 Beerse, | | | | |
| België | | | | |

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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