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)
Date: 2014-05-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014165EN.01000101.xml










29.5.2014   


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.