Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-09-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2016362EN.01000101.xml










30.9.2016   


EN


Official Journal of the European Union


C 362/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 362/01)
—   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




16.8.2016


Cinqaero


reslizumab


Teva Pharmaceuticals Limited
Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom


EU/1/16/1125


Concentrate for solution for infusion


R03DX08


18.8.2016




18.8.2016


Aerivio Spiromax


salmeterol/fluticasone propionate


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


EU/1/16/1122


Inhalation powder


R03AK06


22.8.2016




18.8.2016


Airexar Spiromax


salmeterol/fluticasone propionate


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


EU/1/16/1123


Inhalation powder


R03AK06


22.8.2016




18.8.2016


Nordimet


methotrexate


Nordic Group B.V.
Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland


EU/1/16/1124


Solution for injection


L01BA01


22.8.2016




18.8.2016


Zalmoxis


Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)


MolMed S.p.A.
Via Olgettina 58, I-20132 Milano, Italia


EU/1/16/1121


Dispersion for infusion


Pending


23.8.2016




22.8.2016


Atazanavir Mylan


atazanavir


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/16/1091


Capsule, hard


J05AE08


24.8.2016




25.8.2016


Kisplyx


lenvatinib


Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom


EU/1/16/1128


Capsule, hard


L01XE29


30.8.2016




—   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




1.8.2016


Aripiprazole Mylan Pharma


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/15/1005


3.8.2016




1.8.2016


Ilaris


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


EU/1/09/564


3.8.2016




1.8.2016


Pegasys


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


EU/1/02/221


3.8.2016




1.8.2016


Pradaxa


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


EU/1/08/442


3.8.2016




1.8.2016


Rasagiline ratiopharm


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


EU/1/14/977


3.8.2016




1.8.2016


XALKORI


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


EU/1/12/793


3.8.2016




8.8.2016


Desloratadine ratiopharm


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


EU/1/11/746


10.8.2016




8.8.2016


Desloratadine Teva


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


EU/1/11/732


10.8.2016




8.8.2016


Levetiracetam Actavis Group


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland


EU/1/11/738


10.8.2016




8.8.2016


Plenadren


Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/715


10.8.2016




8.8.2016


Zavesca


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


EU/1/02/238


10.8.2016




9.8.2016


IDflu


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


EU/1/08/507


11.8.2016




9.8.2016


Intanza


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


EU/1/08/505


11.8.2016




9.8.2016


Kaletra


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/01/172


11.8.2016




9.8.2016


Memantine ratiopharm


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


EU/1/13/836


11.8.2016




12.8.2016


Ibandronic acid Accord


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


EU/1/12/798


17.8.2016




12.8.2016


Imvanex


Bavarian Nordic A/S
Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark


EU/1/13/855


17.8.2016




12.8.2016


Myclausen


Passauer Pharma GmbH
Eiderstedter Weg 3, 14129 Berlin, Deutschland


EU/1/10/647


17.8.2016




12.8.2016


Scenesse


Clinuvel UK Limited
Devonshire House, 60 Goswell Road, London EC1M 7AD, United Kingdom


EU/1/14/969


17.8.2016




16.8.2016


Aflunov


Seqirus S.r.l.
Via Fiorentina, 1, Siena, Italia


EU/1/10/658


18.8.2016




16.8.2016


Dasselta


Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/11/739


18.8.2016




16.8.2016


Eylea


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/12/797


18.8.2016




16.8.2016


HALAVEN


Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom


EU/1/11/678


18.8.2016




16.8.2016


Mekinist


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


EU/1/14/931


18.8.2016




18.8.2016


Kaletra


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/01/172


22.8.2016




18.8.2016


KEYTRUDA


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


EU/1/15/1024


22.8.2016




18.8.2016


OLYSIO


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


EU/1/14/924


22.8.2016




18.8.2016


Sevelamer carbonate Zentiva


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


EU/1/14/952


22.8.2016




18.8.2016


Tracleer


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


EU/1/02/220


22.8.2016




18.8.2016


Truvada


Gilead Sciences International Ltd.
Cambridge, CB21 6GT, United Kingdom


EU/1/04/305


22.8.2016




18.8.2016


Vargatef


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


EU/1/14/954


22.8.2016




18.8.2016


Viekirax


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/14/982


22.8.2016




22.8.2016


Brimica Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/963


24.8.2016




22.8.2016


Dificlir


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


EU/1/11/733


24.8.2016




22.8.2016


Duaklir Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/964


24.8.2016




22.8.2016


Lumark


IDB Holland B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland


EU/1/15/1013


24.8.2016




22.8.2016


Nimenrix


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


EU/1/12/767


24.8.2016




22.8.2016


Tasmar


Meda AB
Pipers väg 2A, S-170 09 Solna, Sverige


EU/1/97/044


24.8.2016




25.8.2016


Iclusig


ARIAD Pharma Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom


EU/1/13/839


30.8.2016




25.8.2016


IMBRUVICA


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


EU/1/14/945


29.8.2016




25.8.2016


Orencia


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


EU/1/07/389


30.8.2016




25.8.2016


Renvela


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


EU/1/09/521


29.8.2016




25.8.2016


Revestive


Shire Pharmaceuticals Ireland Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/12/787


29.8.2016




25.8.2016


Tasermity


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


EU/1/14/953


29.8.2016




25.8.2016


VPRIV


Shire Pharmaceuticals Ireland Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/10/646


29.8.2016




25.8.2016


XALKORI


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


EU/1/12/793


30.8.2016




25.8.2016


Zurampic


Grünenthal GmbH
Zieglerstrasse 6, D-52078, Aachen, Deutschland


EU/1/15/1080


29.8.2016




31.8.2016


Ketoconazole HRA


Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, France


EU/1/14/965


2.9.2016




31.8.2016


Renagel


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


EU/1/99/123


2.9.2016




—   Issuing 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


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




12.8.2016


Sedadex


dexmedetomidine


Le Vet Beheer B.V.
Wilgenweg 7, NL-3421 TV Oudewater, Nederland


EU/2/16/198


Solution for injection


QN05CM18


17.8.2016




—   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




9.8.2016


Recocam


Cross Vetpharm Group, Ltd
Broomhill Road, Tallaght Dublin 24, Ireland


EU/2/11/133


11.8.2016




12.8.2016


Metacam


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/97/004


17.8.2016




26.8.2016


Panacur AquaSol


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


EU/2/11/135


30.8.2016




—   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




22.8.2016


Velactis


Ceva Santé Animale
10 av. de La Ballastière, 33500 Libourne, France


EU/2/15/192


24.8.2016




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.