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)
Date: 2014-06-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014199EN.01000101.xml










27.6.2014   


EN


Official Journal of the European Union


C 199/1





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






EU/1/14/929


Inhalation powder, pre-dispensed


R03AK10


6.5.2014




8.5.2014


Anoro


umeclidinium bromide/vilanterol trifenatate







Glaxo Group Ltd




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/14/898


Inhalation powder, pre-dispensed


R03AL03


13.5.2014




8.5.2014


Laventair


umeclidinium bromide/vilanterol trifenatate







Glaxo Group Ltd




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/14/899


Inhalation powder, pre-dispensed


R03AL03


13.5.2014




14.5.2014


OLYSIO


simeprevir







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/14/924


Capsule, hard


J05AE14


16.5.2014




22.5.2014


Ebilfumin


oseltamivir







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/14/915


Capsule, hard


J05AH02


27.5.2014




22.5.2014


Entyvio


vedolizumab







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/14/923


Powder for concentrate for solution for infusion


L04AA33


27.5.2014




22.5.2014


Jardiance


Empagliflozin







Boehringer Ingelheim International GmbH




Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


Film-coated tablet


A10BX12


27.5.2014




22.5.2014


Sylvant


siltuximab







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/14/928


Powder for concentrate for solution for infusion


Pending


27.5.2014




—   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






EU/1/96/026


6.5.2014




6.5.2014


NutropinAq







Ipsen Pharma




65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France






EU/1/00/164


9.5.2014




6.5.2014


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Keltenring 1 + 3, D-82041 Oberhaching, Deutschland






EU/1/09/585


8.5.2014




6.5.2014


Vyndaqel







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/11/717


8.5.2014




7.5.2014


Tresiba







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/12/807


9.5.2014




7.5.2014


Trobalt







Glaxo Group Ltd




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/11/681


9.5.2014




8.5.2014


Clopidogrel Teva Pharma







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/561


14.5.2014




8.5.2014


Zylagren







Krka, d. d., Novo Mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/558


13.5.2014




14.5.2014


Clopidogrel Krka







Krka, d. d., Novo Mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/556


16.5.2014




14.5.2014


InductOs







Medtronic BioPharma B.V.




Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland






EU/1/02/226


16.5.2014




14.5.2014


Isentress







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/436


16.5.2014




14.5.2014


Pandemic influenza vaccine H5N1 BAXTER







Baxter AG




Industriestraße 67, A-1221 Wien, Österreich






EU/1/09/571


16.5.2014




14.5.2014


XALKORI







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/12/793


16.5.2014




14.5.2014


Zyllt







Krka, d. d., Novo Mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/553


16.5.2014




16.5.2014


Afinitor







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/538


20.5.2014




16.5.2014


Cimzia







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/09/544


20.5.2014




16.5.2014


Clopidogrel Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/540


20.5.2014




16.5.2014


Clopidogrel Teva Pharma B.V.







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/10/649


20.5.2014




16.5.2014


Docetaxel Accord







Accord Healthcare Limited




Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom






EU/1/12/769


20.5.2014




16.5.2014


Javlor







Pierre Fabre Médicament




45, place Abel Gance, F-92100 Boulogne, France






EU/1/09/550


20.5.2014




16.5.2014


Vizarsin







Krka, d. d., Novo Mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/551


20.5.2014




22.5.2014


Adjupanrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/578


27.5.2014




22.5.2014


Busilvex







Pierre Fabre Médicament




45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France






EU/1/03/254


27.5.2014




22.5.2014


Clopidogrel DURA







Mylan dura GmbH




Wittichstraße 6, D-64295 Darmstadt, Deutschland






EU/1/09/560


27.5.2014




22.5.2014


Clopidogrel Mylan







Mylan S.A.S




117 allée des Parcs, F-69800 Saint Priest, France






EU/1/09/559


27.5.2014




22.5.2014


Clopidogrel ratiopharm GmbH







Archie Samuel s.r.o.




Slunná 16, CZ-61700 Brno, Česká republika






EU/1/09/541


27.5.2014




22.5.2014


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland






EU/1/09/555


27.5.2014




22.5.2014


Docetaxel Kabi







Fresenius Kabi Oncology Plc.




Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom






EU/1/12/770


27.5.2014




22.5.2014


Fampyra







Biogen Idec Limited




Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom






EU/1/11/699


27.5.2014




22.5.2014


Grastofil







Apotex Europe B.V.




Darwinweg 20, NL- 2333 CR Leiden, Nederland






EU/1/13/877


27.5.2014




22.5.2014


Iasibon







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/10/659


27.5.2014




22.5.2014


Ipreziv







Takeda Pharma A/S




Dybendal Alle 10, 2630 Taastrup, Danmark






EU/1/11/735


27.5.2014




22.5.2014


Osseor







Les Laboratoires Servier




50 rue Carnot, F-92284 Suresnes CEDEX, France






EU/1/04/287


27.5.2014




22.5.2014


PegIntron







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/00/131


27.5.2014




22.5.2014


Prepandrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/08/453


27.5.2014




22.5.2014


Protelos







Les Laboratoires Servier




50 rue Carnot, F-92284 Suresnes CEDEX, France






EU/1/04/288


27.5.2014




22.5.2014


Selincro







H. Lundbeck A/S




Ottiliavej 9, DK-2500 Valby, Danmark






EU/1/12/815


27.5.2014




22.5.2014


Vaniqa







Almirall, S.A.




Ronda General Mitre, 151, E-08022 Barcelona, España






EU/1/01/173


27.5.2014




22.5.2014


ViraferonPeg







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/00/132


27.5.2014




23.5.2014


Clopidogrel Acino







Acino AG




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/532


27.5.2014




23.5.2014


GILENYA







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/11/677


27.5.2014




23.5.2014


Invega







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/07/395


27.5.2014




23.5.2014


Mabthera







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/98/067


27.5.2014




23.5.2014


Nexavar







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/06/342


27.5.2014




23.5.2014


Suboxone







RB Pharmaceuticals Limited




103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom






EU/1/06/359


27.5.2014




—   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






EU/1/06/339


20.5.2014




—   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






EU/2/14/164


Lyophilisate and solvent for suspension for injection


QI07AI02


9.5.2014




7.5.2014


Versican Plus DHPPi/L4R


Versican Plus DHPPi/L4R







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/14/163


Lyophilisate and solvent for suspension for injection


QI07AJ06


9.5.2014




—   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






EU/2/11/133


8.5.2014




16.5.2014


Circovac







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/07/075


20.5.2014




—   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






EU/2/06/058


8.5.2014




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






(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.