# C_2014199EN.01000101.xml

| 27.6.2014 | EN | Official Journal of the European Union | C 199/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2014 to 31 May 2014

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

2014/C 199/01

—   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 |
| ------------------------------------------------------------------ | ----------------------------- | ------------------------------------------- | -------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------ | ----------------------------------------------- | ------------------------------------------------ |
| 2.5.2014 | Revinty Ellipta | 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, United Kingdom | EU/1/14/929 | Inhalation powder, pre-dispensed |
| Glaxo Group Ltd | | | | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | | | | |
| 8.5.2014 | Anoro | umeclidinium bromide/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, United Kingdom | EU/1/14/898 | Inhalation powder, pre-dispensed |
| Glaxo Group Ltd | | | | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | | | | |
| 8.5.2014 | Laventair | umeclidinium bromide/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, United Kingdom | EU/1/14/899 | Inhalation powder, pre-dispensed |
| Glaxo Group Ltd | | | | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | | | | |
| 14.5.2014 | OLYSIO | simeprevir | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/924 | Capsule, hard |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | | | | |
| 22.5.2014 | Ebilfumin | oseltamivir | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/14/915 | Capsule, hard |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | | | | | | | |
| 22.5.2014 | Entyvio | vedolizumab | Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark | Takeda Pharma A/S | Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | Powder for concentrate for solution for infusion |
| Takeda Pharma A/S | | | | | | | |
| Dybendal Alle 10, 2630 Taastrup, Danmark | | | | | | | |
| 22.5.2014 | Jardiance | Empagliflozin | 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 | EU/1/14/930 | Film-coated tablet |
| Boehringer Ingelheim International GmbH | | | | | | | |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | | | | | | | |
| 22.5.2014 | Sylvant | siltuximab | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/928 | Powder for concentrate for solution for infusion |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | | | | |

—   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 |
| ----------------------------------------------------------------------------------------- | -------------------------------------- | --------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------------------------------------------- |
| 2.5.2014 | Invirase | 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 | | | | |
| 6.5.2014 | NutropinAq | 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 | | | | |
| 6.5.2014 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH Keltenring 1 + 3, D-82041 Oberhaching, Deutschland | 1 A Pharma GmbH | Keltenring 1 + 3, D-82041 Oberhaching, Deutschland |
| 1 A Pharma GmbH | | | | |
| Keltenring 1 + 3, D-82041 Oberhaching, Deutschland | | | | |
| 6.5.2014 | Vyndaqel | 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 | | | | |
| 7.5.2014 | Tresiba | 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 | | | | |
| 7.5.2014 | Trobalt | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 8.5.2014 | Clopidogrel Teva Pharma | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 8.5.2014 | Zylagren | 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 | | | | |
| 14.5.2014 | Clopidogrel Krka | 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 | | | | |
| 14.5.2014 | InductOs | Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | Medtronic BioPharma B.V. | Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland |
| Medtronic BioPharma B.V. | | | | |
| Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | | | | |
| 14.5.2014 | Isentress | 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 | | | | |
| 14.5.2014 | Pandemic influenza vaccine H5N1 BAXTER | Baxter AG Industriestraße 67, A-1221 Wien, Österreich | Baxter AG | Industriestraße 67, A-1221 Wien, Österreich |
| Baxter AG | | | | |
| Industriestraße 67, A-1221 Wien, Österreich | | | | |
| 14.5.2014 | XALKORI | 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 | | | | |
| 14.5.2014 | Zyllt | 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 | | | | |
| 16.5.2014 | Afinitor | 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 | | | | |
| 16.5.2014 | 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, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | | | | |
| 16.5.2014 | Clopidogrel Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 16.5.2014 | Clopidogrel Teva Pharma B.V. | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 16.5.2014 | Docetaxel Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
| Accord Healthcare Limited | | | | |
| Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | | | | |
| 16.5.2014 | Javlor | Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France | Pierre Fabre Médicament | 45, place Abel Gance, F-92100 Boulogne, France |
| Pierre Fabre Médicament | | | | |
| 45, place Abel Gance, F-92100 Boulogne, France | | | | |
| 16.5.2014 | Vizarsin | 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 | | | | |
| 22.5.2014 | Adjupanrix | 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 | | | | |
| 22.5.2014 | Busilvex | Pierre Fabre Médicament 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France | Pierre Fabre Médicament | 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France |
| Pierre Fabre Médicament | | | | |
| 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France | | | | |
| 22.5.2014 | Clopidogrel DURA | Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland | Mylan dura GmbH | Wittichstraße 6, D-64295 Darmstadt, Deutschland |
| Mylan dura GmbH | | | | |
| Wittichstraße 6, D-64295 Darmstadt, Deutschland | | | | |
| 22.5.2014 | Clopidogrel Mylan | Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, F-69800 Saint Priest, France |
| Mylan S.A.S | | | | |
| 117 allée des Parcs, F-69800 Saint Priest, France | | | | |
| 22.5.2014 | Clopidogrel ratiopharm GmbH | Archie Samuel s.r.o. Slunná 16, CZ-61700 Brno, Česká republika | Archie Samuel s.r.o. | Slunná 16, CZ-61700 Brno, Česká republika |
| Archie Samuel s.r.o. | | | | |
| Slunná 16, CZ-61700 Brno, Česká republika | | | | |
| 22.5.2014 | Clopidogrel TAD | TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | TAD Pharma GmbH | Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland |
| TAD Pharma GmbH | | | | |
| Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | | | | |
| 22.5.2014 | Docetaxel Kabi | Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | Fresenius Kabi Oncology Plc. | Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom |
| Fresenius Kabi Oncology Plc. | | | | |
| Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | | | | |
| 22.5.2014 | Fampyra | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
| Biogen Idec Limited | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | |
| 22.5.2014 | Grastofil | Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland | Apotex Europe B.V. | Darwinweg 20, NL- 2333 CR Leiden, Nederland |
| Apotex Europe B.V. | | | | |
| Darwinweg 20, NL- 2333 CR Leiden, Nederland | | | | |
| 22.5.2014 | Iasibon | 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 | | | | |
| 22.5.2014 | Ipreziv | Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark | Takeda Pharma A/S | Dybendal Alle 10, 2630 Taastrup, Danmark |
| Takeda Pharma A/S | | | | |
| Dybendal Alle 10, 2630 Taastrup, Danmark | | | | |
| 22.5.2014 | Osseor | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 22.5.2014 | PegIntron | 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 | | | | |
| 22.5.2014 | Prepandrix | 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 | | | | |
| 22.5.2014 | Protelos | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 22.5.2014 | Selincro | H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark | H. Lundbeck A/S | Ottiliavej 9, DK-2500 Valby, Danmark |
| H. Lundbeck A/S | | | | |
| Ottiliavej 9, DK-2500 Valby, Danmark | | | | |
| 22.5.2014 | Vaniqa | Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, E-08022 Barcelona, España |
| Almirall, S.A. | | | | |
| Ronda General Mitre, 151, E-08022 Barcelona, España | | | | |
| 22.5.2014 | ViraferonPeg | 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 | | | | |
| 23.5.2014 | Clopidogrel Acino | Acino AG Am Windfeld 35, 83714 Miesbach, Deutschland | Acino AG | Am Windfeld 35, 83714 Miesbach, Deutschland |
| Acino AG | | | | |
| Am Windfeld 35, 83714 Miesbach, Deutschland | | | | |
| 23.5.2014 | GILENYA | 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 | | | | |
| 23.5.2014 | Invega | 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 | | | | |
| 23.5.2014 | 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 | | | | |
| 23.5.2014 | Nexavar | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 23.5.2014 | Suboxone | RB Pharmaceuticals Limited 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom | RB Pharmaceuticals Limited | 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom |
| RB Pharmaceuticals Limited | | | | |
| 103-105 Bath Road, Slough, Berkshire, SL1 3UH, 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 |
| ---------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------- |
| 16.5.2014 | Preotact | NPS Pharma Holdings Limited Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland | NPS Pharma Holdings Limited | Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland |
| NPS Pharma Holdings Limited | | | | |
| Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland | | | | |

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --------------------------------------------------- | ----------------------------- | ---------------------------------------- | ----------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------- | ----------------------------------------------- | ----------------------------------------------------- |
| 7.5.2014 | Versican Plus DHPPi/L4 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/164 | Lyophilisate and solvent for suspension for injection |
| Zoetis Belgium S.A. | | | | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | | | | |
| 7.5.2014 | Versican Plus DHPPi/L4R | Versican Plus DHPPi/L4R | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/163 | Lyophilisate and solvent for suspension for injection |
| Zoetis Belgium S.A. | | | | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | | | | |

—   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 |
| -------------------------------------------- | ----------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------- |
| 7.5.2014 | Recocam | Cross Vetpharm Group, Ltd Broomhill Road, Tallaght Dublin 24, Ireland | Cross Vetpharm Group, Ltd | Broomhill Road, Tallaght Dublin 24, Ireland |
| Cross Vetpharm Group, Ltd | | | | |
| Broomhill Road, Tallaght Dublin 24, Ireland | | | | |
| 16.5.2014 | Circovac | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |

—   Withdrawal of a marketing authorization (Article 38 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 |
| --------------------------------- | ----------------------------- | ---------------------------------------------------------------- | --------------------------------------------- | --------------------------------- |
| 6.5.2014 | Flexicam | Dechra Veterinary Products A/S Mekuvej 9, DK-7171 Uldum, Danmark | Dechra Veterinary Products A/S | Mekuvej 9, DK-7171 Uldum, Danmark |
| Dechra Veterinary Products A/S | | | | |
| Mekuvej 9, DK-7171 Uldum, Danmark | | | | |

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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