Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-04-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2016154EN.01000101.xml










29.4.2016   


EN


Official Journal of the European Union


C 154/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 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 154/01)
—   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




16.3.2016


Coagadex


human coagulation factor X


Bio Products Laboratory Ltd
Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom


EU/1/16/1087


Powder and solvent for solution for injection


B02BD13


18.3.2016




16.3.2016


Neofordex


dexamethasone


Laboratoires CTRS
63 rue de l’Est, F-92100 Boulogne-Billancourt, France


EU/1/15/1053


Tablet


H02AB02


18.3.2016




22.3.2016


Amlodipine/Valsartan Mylan


amlodipine/valsartan


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


EU/1/16/1092


Film-coated tablet


C09DB01


29.3.2016




31.3.2016


Wakix


Pitolisant hydrochloride


Bioprojet Pharma
9 rue Rameau, F-75002 Paris, France


EU/1/15/1068


Film-coated tablet


N07XX11


4.4.2016




31.3.2016


Zonisamide Mylan


zonisamide


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


EU/1/16/1093


Capsule, hard


N03AX15


4.4.2016




—   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




2.3.2016


Copalia


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


EU/1/06/372


4.3.2016




2.3.2016


Dafiro


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


EU/1/06/371


4.3.2016




2.3.2016


DuoPlavin


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


EU/1/10/619


7.3.2016




2.3.2016


Efavirenz Teva


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


EU/1/11/742


4.3.2016




2.3.2016


Exforge HCT


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


EU/1/09/569


4.3.2016




2.3.2016


Faslodex


AstraZeneca UK Limited
Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom


EU/1/03/269


4.3.2016




2.3.2016


Jentadueto


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


EU/1/12/780


7.3.2016




2.3.2016


Menveo


GSK Vaccines S.r.l.
Via Fiorentina, 1, IT-53100 Siena, Italia


EU/1/10/614


4.3.2016




2.3.2016


Mozobil


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


EU/1/09/537


4.3.2016




2.3.2016


Xydalba


Durata Therapeutics International B.V.
Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland


EU/1/14/986


4.3.2016




7.3.2016


Avamys


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


EU/1/07/434


9.3.2016




7.3.2016


Dacogen


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


EU/1/12/792


9.3.2016




7.3.2016


Signifor


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


EU/1/12/753


9.3.2016




7.3.2016


Triumeq


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


EU/1/14/940


9.3.2016




10.3.2016


Celsentri


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


EU/1/07/418


14.3.2016




10.3.2016


Onglyza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/09/545


14.3.2016




11.3.2016


Deltyba


Otsuka Novel Products GmbH
Erika-Mann-Straße 21, D-80636 München, Deutschland


EU/1/13/875


16.3.2016




11.3.2016


Savene


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


EU/1/06/350


16.3.2016




11.3.2016


Topotecan Teva


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


EU/1/09/552


16.3.2016




16.3.2016


Cuprymina


SPARKLE S.r.l.
Località Cavallino, 62010 Montecosaro (MC), Italia


EU/1/12/784


21.3.2016




22.3.2016


Copalia HCT


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


EU/1/09/575


29.3.2016




22.3.2016


Exforge


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


EU/1/06/370


29.3.2016




22.3.2016


Exjade


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


EU/1/06/356


29.3.2016




22.3.2016


Iclusig


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


EU/1/13/839


29.3.2016




22.3.2016


Kepivance


Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige


EU/1/05/314


29.3.2016




22.3.2016


Laventair


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


EU/1/14/899


29.3.2016




22.3.2016


Mekinist


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


EU/1/14/931


29.3.2016




22.3.2016


Pixuvri


CTI Life Sciences Ltd
Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom


EU/1/12/764


29.3.2016




22.3.2016


Trajenta


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


EU/1/11/707


29.3.2016




22.3.2016


Zykadia


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


EU/1/15/999


29.3.2016




23.3.2016


Elocta


Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige


EU/1/15/1046


30.3.2016




30.3.2016


Abseamed


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37, D-58638 Iserlohn, Deutschland


EU/1/07/412


1.4.2016




30.3.2016


Anoro


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


EU/1/14/898


1.4.2016




30.3.2016


Evra


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


EU/1/02/223


1.4.2016




30.3.2016


TachoSil


Takeda Austria GmbH
St.-Peter-Strasse 25, A-4020 Linz, Österreich


EU/1/04/277


1.4.2016




30.3.2016


Vidaza


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


EU/1/08/488


1.4.2016




31.3.2016


Betmiga


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


EU/1/12/809


4.4.2016




31.3.2016


Binocrit


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/07/410


4.4.2016




31.3.2016


Caelyx


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


EU/1/96/011


4.4.2016




31.3.2016


Capecitabine Teva


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


EU/1/12/761


4.4.2016




31.3.2016


Ecansya


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


EU/1/12/763


4.4.2016




31.3.2016


Epoetin alfa Hexal


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/07/411


4.4.2016




31.3.2016


Eviplera


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/11/737


4.4.2016




31.3.2016


Giotrif


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


EU/1/13/879


4.4.2016




31.3.2016


Lynparza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/959


4.4.2016




31.3.2016


Revatio


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


EU/1/05/318


4.4.2016




31.3.2016


Ruconest


Pharming Group N.V.
Darwinweg 24, NL-2333 CR Leiden, Nederland


EU/1/10/641


4.4.2016




31.3.2016


Vargatef


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


EU/1/14/954


4.4.2016




—   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




2.3.2016


Nuedexta


Jenson Pharmaceutical Services Ltd
Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom


EU/1/13/833


4.3.2016




—   Suspension of a marketing authorisation (Article 20 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




23.3.2016


Zydelig


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/938


30.3.2016




—   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




8.3.2016


Palladia


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


EU/2/09/100


10.3.2016




15.3.2016


BLUEVAC BTV8


CZ Veterinaria, S.A.
La Relva s/n, 36400 Porriño, España


EU/2/11/122


17.3.2016




15.3.2016


Versican Plus DHPPi


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


EU/2/14/169


17.3.2016




15.3.2016


Versican Plus DHPPi/L4


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


EU/2/14/164


17.3.2016




15.3.2016


Versican Plus DHPPi/L4R


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


EU/2/14/163


17.3.2016




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.