Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2016 to 30 November 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2016490EN.01000101.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2016 to 30 November 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 490/01)
—   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




9.11.2016


Emtricitabine/Tenofovir disoproxil Zentiva


emtricitabine/tenofovir disoproxil


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


EU/1/16/1148


Film-coated tablet


J05AR03


11.11.2016




9.11.2016


IBRANCE


palbociclib


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


EU/1/16/1147


Capsule, hard


L01XE33


11.11.2016




9.11.2016


Lartruvo


olaratumab


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


EU/1/16/1143


Concentrate for solution for infusion


L01XC27


11.11.2016




11.11.2016


Glyxambi


empagliflozin/linagliptin


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


EU/1/16/1146


Film-coated tablet


A10BD19


15.11.2016




11.11.2016


Ivabradine JensonR


ivabradine


JensonR+ Limited
Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 UD, United Kingdom


EU/1/16/1145


Film-coated tablet


C01EB17


15.11.2016




11.11.2016


Ivabradine Zentiva


ivabradine


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


EU/1/16/1144


Film-coated tablet


C01EB17


15.11.2016




11.11.2016


Parsabiv


etelcalcetide


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


EU/1/16/1142


Solution for injection


H05BX04


15.11.2016




11.11.2016


XALKORI


crizotinib


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


EU/1/12/793


Capsule, hard


L01XE16


15.11.2016




14.11.2016


Erivedge


vismodegib


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


EU/1/13/848


Capsule, hard


L01XX43


16.11.2016




14.11.2016


Granpidam


sildenafil


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


EU/1/16/1137


Film-coated tablet


G04BE03


16.11.2016




21.11.2016


Ninlaro


ixazomib


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


EU/1/16/1094


Capsule, hard


L01XX50


23.11.2016




—   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




3.11.2016


Daliresp


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/668


7.11.2016




3.11.2016


Emtriva


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/03/261


7.11.2016




3.11.2016


Intanza


Sanofi Pasteur Europe
2 Avenue Pont Pasteur, 69007 Lyon, France


EU/1/08/505


7.11.2016




3.11.2016


Libertek


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/666


7.11.2016




3.11.2016


Vibativ


Theravance Biopharma Ireland Limited
Fitzwilliam Hall, Fitzwilliam Place, Dublin 2, Ireland


EU/1/11/705


7.11.2016




9.11.2016


Iclusig


Incyte Biosciences UK Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom


EU/1/13/839


11.11.2016




9.11.2016


Lyrica


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


EU/1/04/279


11.11.2016




9.11.2016


Sutent


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


EU/1/06/347


11.11.2016




9.11.2016


Zytiga


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


EU/1/11/714


14.11.2016




11.11.2016


Abraxane


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


EU/1/07/428


15.11.2016




11.11.2016


Desloratadine Actavis


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


EU/1/11/745


15.11.2016




11.11.2016


Erivedge


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


EU/1/13/848


15.11.2016




11.11.2016


Foscan


biolitec Pharma Ltd.
Otto-Schott-Str. 15, 07745 Jena, Deutschland


EU/1/01/197


15.11.2016




11.11.2016


Glidipion


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


EU/1/12/756


15.11.2016




11.11.2016


Hexyon


Sanofi Pasteur Europe
2 Avenue Pont Pasteur, 69007 Lyon, France


EU/1/13/829


15.11.2016




11.11.2016


Incruse


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


EU/1/14/922


15.11.2016




11.11.2016


Keppra


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


EU/1/00/146


15.11.2016




11.11.2016


Lojuxta


Aegerion Pharmaceuticals Limited
Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom


EU/1/13/851


15.11.2016




11.11.2016


Lucentis


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


EU/1/06/374


15.11.2016




11.11.2016


Mirvaso


Galderma International
Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France


EU/1/13/904


15.11.2016




11.11.2016


Neuraceq


Piramal Imaging Limited
Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom


EU/1/13/906


15.11.2016




11.11.2016


Picato


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


EU/1/12/796


15.11.2016




11.11.2016


Pioglitazone Actavis


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


EU/1/12/755


15.11.2016




11.11.2016


Pregabalin Pfizer


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


EU/1/14/916


15.11.2016




11.11.2016


Stelara


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


EU/1/08/494


15.11.2016




11.11.2016


Strensiq


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


EU/1/15/1015


15.11.2016




11.11.2016


Taxespira


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


EU/1/15/1017


15.11.2016




11.11.2016


Teysuno


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


EU/1/11/669


15.11.2016




11.11.2016


Translarna


PTC Therapeutics International Limited
77 Sir John Rogerson’s Quay, Dublin 2, Ireland


EU/1/13/902


15.11.2016




14.11.2016


Bretaris Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/781


16.11.2016




14.11.2016


Clopidogrel ratiopharm


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


EU/1/14/975


16.11.2016




14.11.2016


Duloxetine Zentiva


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


EU/1/15/1028


16.11.2016




14.11.2016


Edarbi


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


EU/1/11/734


16.11.2016




14.11.2016


Eklira Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/778


16.11.2016




14.11.2016


Esmya


Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Magyarország


EU/1/12/750


16.11.2016




14.11.2016


Giotrif


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


EU/1/13/879


16.11.2016




14.11.2016


Iasibon


Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα


EU/1/10/659


16.11.2016




14.11.2016


Isentress


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


EU/1/07/436


16.11.2016




14.11.2016


Levetiracetam SUN


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


EU/1/11/741


16.11.2016




14.11.2016


Lucentis


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


EU/1/06/374


16.11.2016




14.11.2016


Numient


Impax Laboratories Ireland Limited, 56 Fitzwilliam Square, Dublin 2, Ireland


EU/1/15/1044


16.11.2016




14.11.2016


Pioglitazone Actavis


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


EU/1/12/755


17.11.2016




14.11.2016


Pioglitazone Teva


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


EU/1/12/757


16.11.2016




14.11.2016


Praluent


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


EU/1/15/1031


16.11.2016




14.11.2016


Ribavirin Teva


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


EU/1/09/509


16.11.2016




14.11.2016


Ribavirin Teva Pharma BV


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


EU/1/09/527


16.11.2016




14.11.2016


Topotecan Hospira


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


EU/1/10/633


16.11.2016




14.11.2016


Trisenox


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


EU/1/02/204


16.11.2016




14.11.2016


Triumeq


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


EU/1/14/940


16.11.2016




18.11.2016


Daxas


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/10/636


22.11.2016




18.11.2016


Jakavi


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


EU/1/12/773


22.11.2016




18.11.2016


Pioglitazone Teva Pharma


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


EU/1/12/758


22.11.2016




18.11.2016


Procysbi


Raptor Pharmaceuticals Europe BV
Naritaweg 165, NL-1043 BW Amsterdam, Nederland


EU/1/13/861


22.12.2016




18.11.2016


Selincro


H. Lundbeck A/S
Ottiliavej 9, DK-2500 Valby, Danmark


EU/1/12/815


22.11.2016




18.11.2016


Signifor


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


EU/1/12/753


22.11.2016




18.11.2016


Thymanax


Servier (Ireland) Industries Limited
Gorey Road, Arklow, Co. Wicklow, Ireland


EU/1/08/498


22.11.2016




18.11.2016


Valdoxan


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes Cedex, France


EU/1/08/499


22.11.2016




18.11.2016


Xaluprine


Nova Laboratories Limited
Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom


EU/1/11/727


22.11.2016




21.11.2016


Ameluz


Biofrontera Bioscience GmbH
Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland


EU/1/11/740


23.11.2016




21.11.2016


Bemfola


Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Magyarország


EU/1/13/909


23.11.2016




21.11.2016


Cystadane


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


EU/1/06/379


23.11.2016




21.11.2016


Elonva


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


EU/1/09/609


23.11.2016




21.11.2016


Opdivo


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


EU/1/15/1014


23.11.2016




29.11.2016


Ammonaps


Swedish Orphan Biovitrum International AB
SE-112 76 Stockholm, Sverige


EU/1/99/120


1.12.2016




29.11.2016


PANTOLOC Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/519


1.12.2016




—   Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




3.11.2016


Vitekta


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/883


7.11.2016




21.11.2016


Celvapan


Nanotherapeutics Bohumil, s.r.o.
Bohumil 138, 28163 Jevany, Česká republika


EU/1/08/506


23.11.2016




—   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




3.11.2016


Fungitraxx


Avimedical B.V.
Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland


EU/2/13/160


7.11.2016




9.11.2016


Draxxin


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


EU/2/03/041


14.11.2016




9.11.2016


Inflacam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/11/134


11.11.2016




9.11.2016


Semintra


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


EU/2/12/146


11.11.2016




11.11.2016


Sileo


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/2/15/181


15.11.2016




29.11.2016


BROADLINE


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


EU/2/13/157


1.12.2016




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.