Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2016 to 31 May 2016 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-06-24
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2016229EN.01000101.xml










24.6.2016   


EN


Official Journal of the European Union


C 229/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2016 to 31 May 2016
(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 229/01)
—   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




11.5.2016


Empliciti


elotuzumab


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


EU/1/16/1088


Powder for concentrate for solution for infusion


L01XC23


13.5.2016




11.5.2016


IDELVION


albutrepenonacog alfa


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


EU/1/16/1095


Powder and solvent for solution for injection


B02BD04


13.5.2016




12.5.2016


ALPROLIX


eftrenonacog alfa


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


EU/1/16/1098


Powder and solvent for solution for injection


B02BD04


13.5.2016




12.5.2016


Uptravi


selexipag


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


EU/1/15/1083


Film-coated tablet


B01AC27


19.5.2016




20.5.2016


Darzalex


daratumumab


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


EU/1/16/1101


Concentrate for solution for infusion


L01XC24


24.5.2016




20.5.2016


Pandemic influenza vaccine H5N1 MedImmune


Pandemic influenza vaccine (H5N1) (live attenuated, nasal)


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


EU/1/16/1089


Nasal spray, suspension


J07BB03


24.5.2016




26.5.2016


Galafold


migalastat


Amicus Therapeutics UK Ltd
Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom


EU/1/15/1082


Capsule, hard


Pending


31.5.2016




26.5.2016


Neparvis


sacubitril/valsartan


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


EU/1/16/1103


Film-coated tablet


C09DX04


30.5.2016




26.5.2016


Palonosetron Accord


palonosetron


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


EU/1/16/1104


Solution for injection


A04AA05


31.5.2016




—   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




2.5.2016


Bortezomib Accord


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


EU/1/15/1019


4.5.2016




2.5.2016


Combivir


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/98/058


4.5.2016




2.5.2016


Ebilfumin


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


EU/1/14/915


4.5.2016




2.5.2016


ellaOne


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


EU/1/09/522


4.5.2016




2.5.2016


HALAVEN


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


EU/1/11/678


4.5.2016




2.5.2016


Harvoni


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/958


4.5.2016




2.5.2016


Ixiaro


Valneva Austria GmbH
Campus Vienna Biocenter 3, A-1030 Wien, Österreich


EU/1/08/501


4.5.2016




2.5.2016


Lyxumia


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


EU/1/12/811


4.5.2016




2.5.2016


Norvir


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/96/016


4.5.2016




2.5.2016


Quadramet


CIS bio international
Boite Postale 32, F-91192 Gif-sur-Yvette, France


EU/1/97/057


4.5.2016




2.5.2016


Synflorix


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


EU/1/09/508


4.5.2016




2.5.2016


Tafinlar


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


EU/1/13/865


4.5.2016




11.5.2016


Desloratadine Actavis


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


EU/1/11/745


13.5.2016




11.5.2016


Humalog


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


EU/1/96/007


13.5.2016




11.5.2016


Humira


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/03/256


13.5.2016




11.5.2016


Imatinib Medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/13/876


13.5.2016




11.5.2016


Inlyta


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


EU/1/12/777


13.5.2016




11.5.2016


Opdivo


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


EU/1/15/1014


13.5.2016




11.5.2016


Plenadren


ViroPharma SPRL-BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/715


13.5.2016




11.5.2016


Zerit


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


EU/1/96/009


13.5.2016




12.5.2016


Brimica Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/963


16.5.2016




12.5.2016


Clopidogrel Mylan


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


EU/1/09/559


17.5.2016




12.5.2016


Desloratadine Teva


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


EU/1/11/732


17.5.2016




12.5.2016


Docetaxel Winthrop


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France


EU/1/07/384


17.5.2016




12.5.2016


Enurev Breezhaler


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


EU/1/12/789


16.5.2016




12.5.2016


Glybera


uniQure biopharma B.V.
Meibergdreef 61, NL-1105 BA Amsterdam, Nederland


EU/1/12/791


17.5.2016




12.5.2016


Integrilin


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/99/109


16.5.2016




12.5.2016


NovoEight


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/13/888


17.5.2016




12.5.2016


Seebri Breezhaler


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


EU/1/12/788


16.5.2016




12.5.2016


Tepadina


ADIENNE S.r.l.
Via Galileo Galilei 19, 20867 Caponago (MB), Italia


EU/1/10/622


16.5.2016




12.5.2016


Tovanor Breezhaler


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


EU/1/12/790


16.5.2016




13.5.2016


Hexacima


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


EU/1/13/828


24.5.2016




17.5.2016


Capecitabine SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland


EU/1/13/831


19.5.2016




17.5.2016


Champix


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


EU/1/06/360


19.5.2016




17.5.2016


Epivir


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/96/015


19.5.2016




17.5.2016


Imatinib Teva


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


EU/1/12/808


19.5.2016




17.5.2016


Wilzin


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France


EU/1/04/286


19.5.2016




20.5.2016


Ceprotin


Baxter AG
Industriestrasse 67, A-1221 Wien, Österreich


EU/1/01/190


24.5.2016




20.5.2016


Clopidogrel Krka d.d.


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


EU/1/09/562


24.5.2016




20.5.2016


Gazyvaro


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


EU/1/14/937


24.5.2016




20.5.2016


Hexyon


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


EU/1/13/829


24.5.2016




26.5.2016


Actos


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


EU/1/00/150


30.5.2016




26.5.2016


Afinitor


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


EU/1/09/538


30.5.2016




26.5.2016


Buccolam


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


EU/1/11/709


30.5.2016




26.5.2016


Capecitabine medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/12/802


30.5.2016




26.5.2016


Cayston


Gilead Sciences International Limited
Granta Park, Abington, Cambridge CB21 6GT, United Kingdom


EU/1/09/543


31.5.2016




26.5.2016


Cinryze


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


EU/1/11/688


30.5.2016




26.5.2016


Clopidogrel/Acetylsalicylic acid Teva


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


EU/1/14/942


30.5.2016




26.5.2016


Clopidogrel HCS


HCS bvba
H. Kennisstraat 53, B-2650 Edegem, België


EU/1/10/651


30.5.2016




26.5.2016


Clopidogrel Teva


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


EU/1/09/540


30.5.2016




26.5.2016


Competact


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


EU/1/06/354


30.5.2016




26.5.2016


Conbriza


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


EU/1/09/511


31.5.2016




26.5.2016


Constella


Allergan Pharmaceuticals International Ltd.
Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland


EU/1/12/801


30.5.2016




26.5.2016


DepoCyte


Pacira Limited
Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom


EU/1/01/187


28.5.2016




26.5.2016


Dexdor


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/11/718


30.5.2016




26.5.2016


Duaklir Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/964


30.5.2016




26.5.2016


Ferriprox


Apotex Europe B.V.
Darwinweg 20, NL-2333 CR Leiden, Nederland


EU/1/99/108


30.5.2016




26.5.2016


Firazyr


Shire Orphan Therapies GmbH
Friedrichstraße 149, D-10117 Berlin, Deutschland


EU/1/08/461


30.5.2016




26.5.2016


Glubrava


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


EU/1/07/421


30.5.2016




26.5.2016


Glustin


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


EU/1/00/151


30.5.2016




26.5.2016


HyQvia


Baxalta Innovations GmbH
Industriestrasse 67, A-1221 Wien, Österreich


EU/1/13/840


30.5.2016




26.5.2016


IMBRUVICA


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


EU/1/14/945


30.5.2016




26.5.2016


Imnovid


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom


EU/1/13/850


31.5.2016




26.5.2016


Levodopa/Carbidopa/Entacapone Orion


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/11/706


30.5.2016




26.5.2016


Liprolog


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


EU/1/01/195


30.5.2016




26.5.2016


Mabthera


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


EU/1/98/067


31.5.2016




26.5.2016


Neulasta


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


EU/1/02/227


30.5.2016




26.5.2016


Nexium Control


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


EU/1/13/860


31.5.2016




26.5.2016


Rixubis


Baxalta Innovations GmbH
Industriestrasse 67, A-1221 Wien, Österreich


EU/1/14/970


30.5.2016




26.5.2016


Strimvelis


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


EU/1/16/1097


30.5.2016




26.5.2016


Tandemact


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


EU/1/06/366


30.5.2016




26.5.2016


Taxotere


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France


EU/1/95/002


30.5.2016




26.5.2016


Trevicta


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


EU/1/14/971


30.5.2016




26.5.2016


Vibativ


Clinigen Healthcare Limited
Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom


EU/1/11/705


28.5.2016




26.5.2016


Victoza


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/09/529


30.5.2016




26.5.2016


XALKORI


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


EU/1/12/793


31.5.2016




26.5.2016


Ytracis


CIS bio international
Boite Postale 32, F-91192 Gif-sur-Yvette, France


EU/1/03/250


30.5.2016




26.5.2016


Zytiga


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


EU/1/11/714


30.5.2016




—   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




3.5.2016


Suvaxyn PCV


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


EU/2/09/099


20.5.2016




17.5.2016


Apoquel


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


EU/2/13/154


19.5.2016




17.5.2016


Bravecto


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


EU/2/13/158


19.5.2016




17.5.2016


MS-H vaccine


Pharmsure International Ltd
Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom


EU/2/11/126


19.5.2016




17.5.2016


Proteq West Nile


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


EU/2/11/129


19.5.2016




26.5.2016


Aivlosin


ECO Animal Health Ltd
78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom


EU/2/04/044


31.5.2016




—   Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




26.5.2016


RevitaCAM


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


EU/2/12/138


30.5.2016




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.