EN Official Journal of the European Union C 165/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 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 165/01

— 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 3.4.2014 Rivastigmine 3M Health Care Ltd. rivastigmine 3M Health Care Limited 1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom EU/1/14/911 Transdermal patch N06DA03 7.4.2014 4.4.2014 Cholic Acid FGK cholic acid FGK Representative Service GmbH Heimeranstraße 35, D-80339 München, Deutschland EU/1/13/895 Capsule, hard A05AA03 8.4.2014 7.4.2014 Para-aminosalicylic acid Lucane Para-aminosalicylic acid Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/896 Gastro-resistant granules J04AA01 9.4.2014 10.4.2014 Pregabalin Pfizer pregabalin Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/14/916 Capsule, hard N03AX16 14.4.2014 23.4.2014 Hemangiol propranolol PIERRE FABRE DERMATOLOGIE 45 place Abel Gance, F- 92100 Boulogne, France EU/1/14/919 Oral solution C07AA05 25.4.2014 23.4.2014 Ulunar Breezhaler indacaterol/glycopyrronium bromide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/14/917 Inhalation powder, hard capsule R03AL04 25.4.2014 23.4.2014 Vokanamet canagliflozin/metformin hydrochloride Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/918 Film-coated tablet A10BD16 25.4.2014 28.4.2014 BiResp Spiromax budesonide/formoterol Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/921 Inhalation powder R03AK07 1.5.2014 28.4.2014 Deltyba delamanid Otsuka Novel Products GmbH Erika-Mann-Straße 21, D-80636 München, Deutschland EU/1/13/875 Film-coated tablet J04AK06 30.4.2014 28.4.2014 DuoResp Spiromax budesonide/formoterol Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/920 Inhalation powder R03AK07 1.5.2014 28.4.2014 Incruse umeclidinium bromide Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/922 Inhalation powder, pre-dispensed R03BB07 30.4.2014 28.4.2014 Vimizim elosulfase alfa BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/14/914 Concentrate and solvent for solution for infusion A16AB12 30.4.2014

— 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 3.4.2014 Neuraceq Piramal Imaging Limited Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, United Kingdom EU/1/13/906 9.4.2014 3.4.2014 Xiapex Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/11/671 7.4.2014 7.4.2014 Exelon Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066 9.4.2014 10.4.2014 Abilify Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/04/276 14.4.2014 10.4.2014 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/09/559 14.4.2014 10.4.2014 Lonquex UAB ‘Sicor Biotech’ V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania EU/1/13/856 15.4.2014 10.4.2014 Pixuvri CTI Life Sciences Ltd Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 14.4.2014 10.4.2014 Viramune Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/055 14.4.2014 11.4.2014 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535 15.4.2014 11.4.2014 Mozobil Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/537 15.4.2014 11.4.2014 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 15.4.2014 15.4.2014 Osseor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/287 17.4.2014 15.4.2014 Protelos Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/288 17.4.2014 23.4.2014 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/04/306 25.4.2014 23.4.2014 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/12/809 25.4.2014 23.4.2014 Bretaris Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/12/781 25.4.2014 23.4.2014 CANCIDAS Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196 25.4.2014 23.4.2014 Eklira Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/12/778 25.4.2014 23.4.2014 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/06/365 25.4.2014 23.4.2014 Ferriprox Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland EU/1/99/108 25.4.2014 23.4.2014 Instanyl Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/09/531 25.4.2014 23.4.2014 Integrilin Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/109 25.4.2014 23.4.2014 Iressa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/09/526 25.4.2014 23.4.2014 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/01/191 25.4.2014 23.4.2014 Nimenrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/12/767 25.4.2014 23.4.2014 Noxafil Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/320 28.4.2014 23.4.2014 Onglyza Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545 25.4.2014 23.4.2014 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221 25.4.2014 23.4.2014 Qutenza Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/09/524 25.4.2014 23.4.2014 Rivastigmine HEXAL Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/09/589 25.4.2014 23.4.2014 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 28.4.2014 23.4.2014 Ryzodeg Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/806 25.4.2014 23.4.2014 Siklos Addmedica 101 rue Saint Lazare, F-75009 Paris, France EU/1/07/397 25.4.2014 23.4.2014 Stocrin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111 25.4.2014 23.4.2014 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 25.4.2014 23.4.2014 Vedrop Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/09/533 25.4.2014 23.4.2014 Vfend Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212 28.4.2014 23.4.2014 Volibris Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/08/451 25.4.2014 28.4.2014 alli Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/401 30.4.2014 28.4.2014 Avamys Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/434 30.4.2014 28.4.2014 Exjade Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356 30.4.2014 28.4.2014 Glybera uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland EU/1/12/791 30.4.2014 28.4.2014 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389 30.4.2014 28.4.2014 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221 30.4.2014 28.4.2014 Rebetol Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/107 30.4.2014 28.4.2014 Ribavirin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/10/634 30.4.2014 28.4.2014 Ribavirin Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/509 1.5.2014 28.4.2014 Ribavirin Teva Pharma BV Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/527 1.5.2014 28.4.2014 Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland EU/1/09/599 30.4.2014 28.4.2014 Tepadina ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/10/622 30.4.2014 28.4.2014 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 30.4.2014

— 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 11.4.2014 Parvoduk Live attenuated Muscovy duck parvovirus Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/14/162 Suspension and diluent for suspension for injection QI01BD03 15.4.2014

— 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 7.4.2014 Aftovaxpur Doe Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/153 9.4.2014 10.4.2014 Equilis StrepE Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/04/043 14.4.2014 10.4.2014 Improvac Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/095 14.4.2014 11.4.2014 BTVPUR AlSap 2-4 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/108 15.4.2014

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, 30.4.04, p. 1.

(2) OJ L 136, 30.4.04, p. 1.