Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-09-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015318EN.01000101.xml










25.9.2015   


EN


Official Journal of the European Union


C 318/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2015/C 318/01)
—   Issuing of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




14.8.2015


Odomzo


sonidegib


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/15/1030


Capsule, hard


L01XX48


18.8.2015




14.8.2015


Unituxin


dinutuximab


United Therapeutics Europe Ltd
Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom


EU/1/15/1022


Concentrate for solution for infusion


L01XC16


18.8.2015




20.8.2015


Aripiprazole Sandoz


Aripiprazole


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1029


Tablet


N05AX12


24.8.2015




20.8.2015


Duloxetine Zentiva


duloxetine


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/15/1028


Gastro-resistant capsule, hard


N06AX21


25.8.2015




20.8.2015


Respreeza


human alpha1-proteinase inhibitor


CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/15/1006


Powder and solvent for solution for infusion


B02AB02


25.8.2015




28.8.2015


Docetaxel Hospira UK Limited


docetaxel


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/15/1017


Concentrate for solution for infusion


L01CD02


1.9.2015




28.8.2015


Farydak


panobinostat


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/15/1023


Capsule, hard


L01XX42


1.9.2015




28.8.2015


Kanuma


sebelipase alfa


Synageva BioPharma Ltd
1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom


EU/1/15/1033


Concentrate and solvent for solution for infusion


Pending


1.9.2015




28.8.2015


Pregabalin Accord


pregabalin


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


EU/1/15/1027


Capsule, hard


N03AX16


1.9.2015




28.8.2015


Strensiq


asfotase alfa


Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France


EU/1/15/1015


Solution for injection


Pending


1.9.2015




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




6.8.2015


Aerius


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/00/160


10.8.2015




6.8.2015


Azomyr


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/00/157


10.8.2015




6.8.2015


IDflu


Sanofi Pasteur SA
2 avenue Pont Pasteur, F-69007 Lyon, France


EU/1/08/507


10.8.2015




6.8.2015


Intanza


Sanofi Pasteur MSD SNC
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/08/505


10.8.2015




12.8.2015


Cyanokit


SERB S.A.
Avenue Louise 480, 1050 Brussels, Belgique


EU/1/07/420


14.8.2015




12.8.2015


Retacrit


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom


EU/1/07/431


14.8.2015




14.8.2015


Cialis


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/02/237


18.8.2015




14.8.2015


Komboglyze


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/731


18.8.2015




14.8.2015


Norvir


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/96/016


18.8.2015




20.8.2015


Adcirca


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/08/476


24.8.2015




20.8.2015


BeneFIX


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


EU/1/97/047


24.8.2015




20.8.2015


Eliquis


Bristol-Myers Squibb/Pfizer EEIG
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom


EU/1/11/691


24.8.2015




20.8.2015


Entyvio


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/14/923


24.8.2015




20.8.2015


Eporatio


ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/09/573


24.8.2015




20.8.2015


Fareston


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/96/004


24.8.2015




20.8.2015


Infanrix hexa


GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89, 1330 Rixensart, Belgique


EU/1/00/152


1.9.2015




20.8.2015


Invokana


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/13/884


24.8.2015




20.8.2015


Kalydeco


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/12/782


27.8.2015




20.8.2015


Keppra


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/00/146


24.8.2015




20.8.2015


OLYSIO


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/14/924


24.8.2015




20.8.2015


Qutenza


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/09/524


24.8.2015




20.8.2015


Stayveer


Marklas Nederland B.V.
Beneluxlaan 2b, NL-3446 GR Woerden, Nederland


EU/1/13/832


24.8.2015




20.8.2015


Tracleer


Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/02/220


24.8.2015




20.8.2015


Twynsta


Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland


EU/1/10/648


24.8.2015




20.8.2015


Vokanamet


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/14/918


24.8.2015




25.8.2015


Adasuve


Ferrer Internacional S.A.
Gran Via Carlos III, 94 08028 Barcelona Spain


EU/1/13/823


27.8.2015




25.8.2015


Biopoin


Teva GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/09/565


27.8.2015




25.8.2015


IDflu


Sanofi Pasteur SA
2 avenue Pont Pasteur, F-69007 Lyon, France


EU/1/08/507


27.8.2015




25.8.2015


Intanza


Sanofi Pasteur MSD SNC
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/08/505


27.8.2015




25.8.2015


Mekinist


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/14/931


27.8.2015




25.8.2015


Optaflu


Novartis Influenza Vaccines Marburg GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/07/394


27.8.2015




25.8.2015


Revolade


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/10/612


27.8.2015




25.8.2015


Tafinlar


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/13/865


27.8.2015




25.8.2015


Temozolomide Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/09/606


27.8.2015




25.8.2015


Zykadia


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/15/999


27.8.2015




28.8.2015


Fluenz Tetra


MedImmune, LLC
Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland


EU/1/13/887


1.9.2015




—   Issuing of a marketing authorisation (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


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




28.8.2015


Porcilis PCV ID


Porcine circovirus type 2 ORF2 subunit antigen


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/15/187


Emulsion for injection


QI09AA07


1.9.2015




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




6.8.2015


Advocate


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/03/039


10.8.2015




20.8.2015


Eurican Herpes 205


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/01/029


24.8.2015




28.8.2015


Equilis StrepE


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/04/043


1.9.2015




28.8.2015


Fevaxyn Pentofel


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/96/002


1.9.2015




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.