# C_2013154EN.01000101.xml

| 31.5.2013 | EN | Official Journal of the European Union | C 154/1 |
| --------- | -- | -------------------------------------- | ------- |

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

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

2013/C 154/01

—   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 |
| ------------------------------------------------------------------ | ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------ | ----------------------------------------------- | --------------------------------- |
| 17.4.2013 | Hexacima | Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) | Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France | Sanofi Pasteur SA | 2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | Suspension for injection |
| Sanofi Pasteur SA | | | | | | | |
| 2 avenue Pont Pasteur, F-69007 Lyon, France | | | | | | | |
| 17.4.2013 | Hexyon | diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France | EU/1/13/829 | Suspension for injection |
| Sanofi Pasteur MSD, SNC | | | | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | | | | |
| 17.4.2013 | Imatinib Actavis | Imatinib | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/13/825 | Capsule, hard
Film-coated tablet |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | | | | | | | |
| 22.4.2013 | Memantine LEK | Memantine | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/13/826 | Film-coated tablet |
| Pharmathen S.A. | | | | | | | |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | | | | | | | |
| 22.4.2013 | Memantine Mylan | Memantine | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | Generics [UK] Limited | Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/13/827 | Film-coated tablet |
| Generics [UK] Limited | | | | | | | |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | | | | | | | |
| 22.4.2013 | Nemdatine | Memantine | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/13/824 | Film-coated tablet |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | | | | | | | |
| 29.4.2013 | Maruxa | Memantine | Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | Krka, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/820 | Film-coated tablet |
| Krka, d. d., Novo mesto | | | | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | | | | |

—   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 |
| ----------------------------------------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------------------------------------- |
| 9.4.2013 | NULOJIX | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 9.4.2013 | Oprymea | Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | Krka, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| Krka, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 9.4.2013 | Thalidomide Celgene | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | | | | |
| 9.4.2013 | Xiapex | Auxilium UK Limited Orchard Lea, Winkfield Lane, Windsor, Berks SL4 4RU, United Kingdom | Auxilium UK Limited | Orchard Lea, Winkfield Lane, Windsor, Berks SL4 4RU, United Kingdom |
| Auxilium UK Limited | | | | |
| Orchard Lea, Winkfield Lane, Windsor, Berks SL4 4RU, United Kingdom | | | | |
| 10.4.2013 | Rasitrio | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.4.2013 | Competact | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 17.4.2013 | Doribax | 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 | | | | |
| 17.4.2013 | Rasilez | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.4.2013 | Rasilez HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.4.2013 | Rivastigmine Actavis | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | | | | |
| 17.4.2013 | Tyverb | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 17.4.2013 | Viagra | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 22.4.2013 | Emselex | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 22.4.2013 | Incivo | 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 | | | | |
| 22.4.2013 | INCRELEX | Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | Ipsen Pharma | 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
| Ipsen Pharma | | | | |
| 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | | | | |
| 22.4.2013 | Jentadueto | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 22.4.2013 | Mabthera | 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, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 22.4.2013 | Rasilamlo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 22.4.2013 | Tandemact | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 22.4.2013 | Trajenta | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 22.4.2013 | Vedrop | Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | Orphan Europe S.A.R.L. | Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
| Orphan Europe S.A.R.L. | | | | |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | | | | |
| 29.4.2013 | Actos | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 29.4.2013 | Glubrava | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 29.4.2013 | Glustin | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 29.4.2013 | Soliris | Alexion Europe SAS 25 boulevard de l'Amiral Bruix, F-75016 Paris, France | Alexion Europe SAS | 25 boulevard de l'Amiral Bruix, F-75016 Paris, France |
| Alexion Europe SAS | | | | |
| 25 boulevard de l'Amiral Bruix, F-75016 Paris, France | | | | |
| 29.4.2013 | Stocrin | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 29.4.2013 | Sustiva | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 29.4.2013 | Viread | 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 | | | | |

—   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 |
| ---------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------- |
| 10.4.2013 | Pelzont | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 10.4.2013 | Tredaptive | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 10.4.2013 | Trevaclyn | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |

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

| Date of the 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 |
| -------------------------------------------------- | ----------------------------- | ---------------------------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------------- | ----------------------------------------------- | ------------------------ |
| 10.4.2013 | ECOPORC SHIGA | Genetically modified recombinant Stx2e antigen | IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | IDT Biologika GmbH | Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | EU/2/13/149 | Suspension for injection |
| IDT Biologika GmbH | | | | | | | |
| Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | | | | | | | |
| 22.4.2013 | Meloxidolor | Meloxicam | Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland | Le Vet Beheer B.V. | Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/13/148 | Solution for injection |
| Le Vet Beheer B.V. | | | | | | | |
| Wilgenweg 7, NL-3421 TV Oudewater, Nederland | | | | | | | |

—   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 |
| ----------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- |
| 10.4.2013 | Equilis Prequenza Te | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | |

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| ----------------------------- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK-LONDON E14 4H |

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( 1 )  OJ L 136, 30.4.2004, p. 1.

( 2 )  OJ L 136, 30.4.2004, p. 1.

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