Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 October 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-11-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018433EN.01000601.xml










30.11.2018   


EN


Official Journal of the European Union


C 433/6






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 October 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 433/02)






—



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




31.10.2018


Symkevi


tezacaftor/ivacaftor


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


EU/1/18/1306


Film-coated tablet


R07AX31


6.11.2018










—



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




4.10.2018


Exviera


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/14/983


8.10.2018




4.10.2018


Grastofil


Apotex Europe B.V.
Archimedesweg 2, 2333 CN Leiden, Nederland


EU/1/13/877


8.10.2018




4.10.2018


Palonosetron Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/16/1100


8.10.2018




10.10.2018


Irbesartan Zentiva


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


EU/1/06/376


12.10.2018




10.10.2018


Kalydeco


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


EU/1/12/782


12.10.2018




11.10.2018


Riximyo


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/17/1184


15.10.2018




16.10.2018


ABILIFY MAINTENA


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland


EU/1/13/882


18.10.2018




16.10.2018


Kivexa


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/04/298


18.10.2018




16.10.2018


Leflunomide Zentiva


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


EU/1/09/604


18.10.2018




16.10.2018


Rapamune


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/01/171


18.10.2018




16.10.2018


Sutent


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/06/347


18.10.2018




18.10.2018


Evoltra


Genzyme Europe B.V.
Gooimeer 10, 1411 DD Naarden, Nederland


EU/1/06/334


22.10.2018




18.10.2018


Forsteo


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/03/247


22.10.2018




18.10.2018


Irbesartan/Hydrochlorothiazide Teva


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


EU/1/09/583


22.10.2018




18.10.2018


Pemetrexed Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/15/1057


22.10.2018




18.10.2018


Velphoro


Vifor Fresenius Medical Care Renal Pharma France
100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France


EU/1/14/943


22.10.2018




23.10.2018


Cosentyx


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/980


25.10.2018




23.10.2018


Micardis


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


EU/1/98/090


25.10.2018




23.10.2018


XALKORI


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/12/793


25.10.2018




23.10.2018


Xtandi


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


EU/1/13/846


25.10.2018




23.10.2018


Zinbryta


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


EU/1/16/1107


25.10.2018




25.10.2018


Clopidogrel/Acetylsalicylic acid Zentiva


Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France


EU/1/10/623


29.10.2018




25.10.2018


Clopidogrel Zentiva


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


EU/1/08/465


29.10.2018




25.10.2018


Cyltezo


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


EU/1/17/1240


29.10.2018




25.10.2018


DuoPlavin


Sanofi Clir SNC
54 rue La Boétie, 75008 Paris, France


EU/1/10/619


29.10.2018




25.10.2018


Iscover


Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France


EU/1/98/070


29.10.2018




25.10.2018


Plavix


Sanofi Clir SNC
54 rue La Boétie, 75008 Paris, France


EU/1/98/069


29.10.2018




25.10.2018


Replagal


Shire Human Genetic Therapies AB
Vasagatan 7, 111 20 Stockholm, Sverige


EU/1/01/189


29.10.2018




25.10.2018


Sustiva


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/99/110


29.10.2018




25.10.2018


Synflorix


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


EU/1/09/508


29.10.2018




29.10.2018


AMGEVITA


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/16/1164


31.10.2018




29.10.2018


Evista


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/98/073


31.10.2018




29.10.2018


Imraldi


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/17/1216


31.10.2018




29.10.2018


Integrilin


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/99/109


31.10.2018




29.10.2018


Protopic


Leo Pharma A/S
Industriparken 55, 2750 Ballerup, Danmark


EU/1/02/201


1.11.2018




29.10.2018


RoActemra


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/08/492


31.10.2018




29.10.2018


Taxespira


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


EU/1/15/1017


31.10.2018




29.10.2018


Venclyxto


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/16/1138


31.10.2018




29.10.2018


Volibris


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/08/451


31.10.2018




31.10.2018


Arzerra


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/10/625


6.11.2018




31.10.2018


Elebrato Ellipta


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/17/1237


6.11.2018




31.10.2018


Neulasta


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/02/227


6.11.2018




31.10.2018


Samsca


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland


EU/1/09/539


6.11.2018




31.10.2018


Trelegy Ellipta


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/17/1236


6.11.2018










—



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




29.10.2018


Lusduna


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/16/1162


31.10.2018




30.10.2018


Taxespira


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


EU/1/15/1017


1.11.2018










—



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




17.10.2018


Recocam


Bimeda Animal Health Limited
2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland


EU/2/11/133


19.10.2018




18.10.2018


NexGard


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/159


22.10.2018




18.10.2018


NEXGARD SPECTRA


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/14/177


22.10.2018




23.10.2018


Canigen L4


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


EU/2/15/183


25.10.2018




30.10.2018


Dexdomitor


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/2/02/033


1.11.2018




30.10.2018


Improvac


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


EU/2/09/095


5.11.2018




30.10.2018


Zolvix


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/09/101


1.11.2018




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.