29.4.2016

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.

29.4.2016

Official Journal of the European Union

C 154/8

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2016/C 154/02)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision	Name(s) of the medicinal product	INN (International Non-Proprietary Name)	Holder(s) of the marketing authorisation	Member State concerned	Date of notification
22.3.2016	Closamectin Pour-On Solution and associated names — Art. 78	Closantel and ivermectin	See Annex	See Annex	29.3.2016
7.3.2016	Rivastigmine Rectificative Decision PSUSA 2654 201501	Rivastigmine	Not applicable	Not applicable	8.3.2016

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX

List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holder in the Member States

Member State (EU/EEA)	Marketing authorisation holder	Product name	INN	Strength	Pharmaceutical form	Animal species	Route of administration
Austria	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Belgium	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Czech Republic	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet — pour-on	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Denmark	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin Pour-On	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
France	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Germany	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Greece	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Ireland	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Ireland	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closivet Pour-On Solution for Cattle	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Italy	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Italy	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Poland	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Portugal	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Romania	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Spain	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Spain	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closivet Solución Pour-On	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Sweden	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Slovenia	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
Slovakia	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
United Kingdom	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
United Kingdom	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use
United Kingdom	Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland	Norofas Pour-On Solution for Cattle	Ivermectin Closantel	5 mg/ml 200 mg/ml	Pour-On solution	Cattle	Topical use

		ISSN 1977-091X
Official Journal of the European Union		C 154

English edition	Information and Notices	Volume 59 29 April 2016

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2016/C 154/01	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 154/02	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)	8