Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2019-03-04
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2019080EN.01000101.xml










4.3.2019   


EN


Official Journal of the European Union


C 80/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2019/C 80/01)






—



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




7.1.2019


Silodosin Recordati


silodosin


Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland


EU/1/18/1343


Capsule, hard


G04CA04


9.1.2019




11.1.2019


Macimorelin Aeterna Zentaris


macimorelin


Æterna Zentaris GmbH
Weismüllerstraße 50, 60314 Frankfurt am Main, Deutschland


EU/1/18/1337


Granules for oral solution


V04CD06


15.1.2019




14.1.2019


Erleada


apalutamide


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


EU/1/18/1342


Film-coated tablet


L02BB05


16.1.2019










—



Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected














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




7.1.2019


Eladynos


Radius International Ltd
Liberty House, 222 Regent Street, W1B 5TR, London, United Kingdom


—


23.1.2019










—



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




7.1.2019


Ivabradine Anpharm


ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B, 03–236 Warszawa, Polska


EU/1/15/1041


9.1.2019




7.1.2019


Omidria


Omeros London Limited
Berkeley Square House, Berkeley Square, London, W1J 6BD, United Kingdom


EU/1/15/1018


9.1.2019




7.1.2019


Pregabalin Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1011


9.1.2019




7.1.2019


Pregabalin Sandoz GmbH


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1012


9.1.2019




7.1.2019


Strensiq


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


EU/1/15/1015


10.1.2019




7.1.2019


Thymanax


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


EU/1/08/498


9.1.2019




11.1.2019


Corlentor


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


EU/1/05/317


15.1.2019




11.1.2019


Ebymect


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1051


16.1.2019




11.1.2019


Hemangiol


Pierre Fabre Dermatologie
45 place Abel Gance, 92100 Boulogne, France


EU/1/14/919


15.1.2019




11.1.2019


Hizentra


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


EU/1/11/687


15.1.2019




11.1.2019


Imatinib Actavis


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


EU/1/13/825


15.1.2019




11.1.2019


Incruse Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/922


15.1.2019




11.1.2019


KEYTRUDA


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/15/1024


15.1.2019




11.1.2019


Laventair Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/899


15.1.2019




11.1.2019


Opdivo


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


EU/1/15/1014


15.1.2019




11.1.2019


Orbactiv


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/15/989


16.1.2019




11.1.2019


Ovaleap


Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland


EU/1/13/871


16.1.2019




11.1.2019


Procoralan


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


EU/1/05/316


15.1.2019




11.1.2019


Savene


Clinigen Healthcare B.V.
Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ Schiphol, The Netherlands


EU/1/06/350


17.1.2019




11.1.2019


Sirturo


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


EU/1/13/901


15.1.2019




11.1.2019


Symkevi


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/18/1306


15.1.2019




11.1.2019


Tamiflu


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/02/222


16.1.2019




11.1.2019


Vepacel


Ology Bioservices Ireland LTD
Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland


EU/1/12/752


16.1.2019




11.1.2019


Vizamyl


GE Healthcare AS
Nycoveien 1, 0485, Oslo, Norge


EU/1/14/941


15.1.2019




11.1.2019


Yervoy


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


EU/1/11/698


15.1.2019




14.1.2019


Cyltezo


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


EU/1/17/1240


16.1.2019




14.1.2019


Onivyde


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


EU/1/16/1130


16.1.2019




15.1.2019


Anoro Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/898


17.1.2019




15.1.2019


Armisarte


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


EU/1/15/1063


17.1.2019




15.1.2019


Caprelsa


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


EU/1/11/749


17.1.2019




15.1.2019


Hemangiol


Pierre Fabre Dermatologie
45 place Abel Gance, 92100 Boulogne, France


EU/1/14/919


17.1.2019




15.1.2019


Holoclar


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/14/987


17.1.2019




15.1.2019


Natpar


Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND


EU/1/15/1078


17.1.2019




15.1.2019


Orkambi


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/15/1059


17.1.2019




15.1.2019


RoActemra


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/08/492


17.1.2019




15.1.2019


Ulunar Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/917


17.1.2019




17.1.2019


CRYSVITA


Kyowa Kirin Holdings B.V.
Bloemlaan 2, 2132 NP Hoofddorp, Nederland


EU/1/17/1262


21.1.2019




18.1.2019


Adempas


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/907


22.1.2019




18.1.2019


Blincyto


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


EU/1/15/1047


22.1.2019




18.1.2019


Dexdor


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/11/718


22.1.2019




18.1.2019


Lumigan


Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland


EU/1/02/205


22.1.2019




18.1.2019


Silapo


STADA Arzneimittel AG
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland


EU/1/07/432


22.1.2019




21.1.2019


Humalog


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


EU/1/96/007


23.1.2019




21.1.2019


Lonquex


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


EU/1/13/856


23.1.2019




23.1.2019


Axumin


Blue Earth Diagnostics Ireland Ltd
6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland


EU/1/17/1186


25.1.2019




23.1.2019


Biopoin


Teva GmbH
Graf-Arco-Straße 3, 89079 Ulm, Deutschland


EU/1/09/565


25.1.2019




23.1.2019


Bronchitol


Pharmaxis Europe Limited
108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland


EU/1/12/760


25.1.2019




23.1.2019


Dacogen


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


EU/1/12/792


25.1.2019




23.1.2019


Emtricitabine/Tenofovir disoproxil Zentiva


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


EU/1/16/1148


6.2.2019




23.1.2019


Infanrix hexa


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


EU/1/00/152


25.1.2019




23.1.2019


Juluca


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/18/1282


25.1.2019




23.1.2019


Luxturna


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/18/1331


25.1.2019




23.1.2019


OCALIVA


Intercept Pharma International Ltd
10 Earlsfort Terrace, Dublin 2, Ireland


EU/1/16/1139


28.1.2019




23.1.2019


Pregabalin Accord


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


EU/1/15/1027


25.1.2019




23.1.2019


Rapiscan


GE Healthcare AS
Nycoveien 1, 0485, Oslo, Norge


EU/1/10/643


25.1.2019




23.1.2019


Revestive


Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland


EU/1/12/787


25.1.2019




23.1.2019


Rubraca


Clovis Oncology Ireland Limited
Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland


EU/1/17/1250


25.1.2019




23.1.2019


Topotecan Teva


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


EU/1/09/552


25.1.2019




23.1.2019


Trimbow


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/17/1208


25.1.2019




23.1.2019


Zoely


Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland


EU/1/11/690


25.1.2019




31.1.2019


Aripiprazole Accord


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


EU/1/15/1045


4.2.2019




31.1.2019


Clopidogrel Teva


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


EU/1/09/540


4.2.2019




31.1.2019


Combivir


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/98/058


4.2.2019




31.1.2019


Elmiron


bene-Arzneimittel GmbH
Herterichstraße 1-3, 81479 München, Deutschland


EU/1/17/1189


4.2.2019




31.1.2019


Feraccru


Norgine B.V.
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland


EU/1/15/1075


4.2.2019




31.1.2019


Imatinib Medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland


EU/1/13/876


4.2.2019




31.1.2019


Memantine Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/13/880


4.2.2019




31.1.2019


Nplate


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


EU/1/08/497


4.2.2019




31.1.2019


Olanzapine Glenmark


Glenmark Arzneimittel GmbH
Industriestr. 31, D — 82194 Gröbenzell, Deutschland


EU/1/09/587


4.2.2019




31.1.2019


Olanzapine Glenmark Europe


Glenmark Arzneimittel GmbH
Industriestr. 31, D — 82194 Gröbenzell, Deutschland


EU/1/09/588


4.2.2019




31.1.2019


Onivyde


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


EU/1/16/1130


4.2.2019




31.1.2019


Plenadren


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


EU/1/11/715


4.2.2019




31.1.2019


Privigen


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


EU/1/08/446


4.2.2019




31.1.2019


Resolor


Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland


EU/1/09/581


4.2.2019




31.1.2019


Respreeza


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


EU/1/15/1006


4.2.2019




31.1.2019


Revestive


Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland


EU/1/12/787


4.2.2019




31.1.2019


Reyataz


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


EU/1/03/267


4.2.2019




31.1.2019


Stalevo


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/03/260


4.2.2019




31.1.2019


Taxotere


Aventis Pharma S.A.
20 avenue Raymond Aron, 92165 Antony Cedex, France


EU/1/95/002


4.2.2019




31.1.2019


Vizarsin


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


EU/1/09/551


4.2.2019




31.1.2019


Xaluprine


Nova Laboratories Ireland Limited
3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland


EU/1/11/727


4.2.2019




31.1.2019


Zoely


Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland


EU/1/11/690


4.2.2019










—



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




11.1.2019


Topotecan Actavis


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


EU/1/09/536


15.1.2019




15.1.2019


Cyltezo


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


EU/1/17/1240


17.1.2019










—



Issuing 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


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




9.1.2019


Isemid


Torasemide


Ceva Santé Animale
10 avenue de la Ballastière, 33500 Libourne, France


EU/2/18/232


Chewable tablet


QC03CA04


11.1.2019




9.1.2019


Syvazul BTV


Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)


LABORATORIOS SYVA, S.A.U.
Av. Párroco Pablo Diez 49-57, 24010 León, España


EU/2/18/231


Suspension for injection


QI04AA02


11.1.2019










—



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




9.1.2019


Parvoduk


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/14/162


11.1.2019




11.1.2019


Meloxidyl


Ceva Santé Animale
10 avenue de la Ballastière, 33500 Libourne, France


EU/2/06/070


15.1.2019




23.1.2019


Loxicom


Norbrook Laboratories Ltd
Station Works, Newry, Co. Down, BT35 6JP, United Kindgom


EU/2/08/090


25.1.2019




24.1.2019


Clomicalm


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/98/007


28.1.2019




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.