Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1June 2019 to 30 June 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2019-07-26
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2019252EN.01000101.xml










26.7.2019   


EN


Official Journal of the European Union


C 252/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2019 to 30 June 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 252/01)






—



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




6.6.2019


Pixuvri


pixantrone


CTI Life Sciences Deutschland GmbH
Universitätsstraβe 71, 50931 Köln, Deutschland


EU/1/12/764


Powder for concentrate for solution for infusion


L01DB11


11.6.2019




12.6.2019


Temybric Ellipta


fluticasone furoate / umeclidinium / vilanterol


GlaxoSmithKline Trading Services Limited Currabinny, Co. Cork, Ireland


EU/1/19/1378


Inhalation powder, pre-dispensed


R03AL08


14.6.2019




20.6.2019


Ambrisentan Mylan


ambrisentan


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


EU/1/19/1368


Film-coated tablet


C02KX02


24.6.2019




20.6.2019


Doptelet


avatrombopag


Dova Pharmaceuticals Ireland Limited
6th Floor, 2 Grand Canal Square, Dublin 2, D02 A342, Ireland


EU/1/19/1373


Film-coated tablet


B02BX08


24.6.2019




20.6.2019


Esperoct


turoctocog alfa pegol


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


EU/1/19/1374


Powder and solvent for solution for injection


B02BD02


24.6.2019




20.6.2019


Grasustek


pegfilgrastim


Juta Pharma GmbH
Gutenbergstr. 13, 24941, Flensburg, Deutschland


EU/1/19/1375


Solution for injection


L03AA13


24.6.2019




20.6.2019


Sixmo


buprenorphine


L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A
Strada Statale 67, 50018 Scandicci (Firenze), Italia


EU/1/19/1369


Implant


N07BC01


25.6.2019




20.6.2019


Talzenna


talazoparib


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België


EU/1/19/1377


Capsule, hard


L01XX60


24.6.2019




20.6.2019


Trecondi


treosulfan


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


EU/1/18/1351


Powder for solution for infusion


L01AB02


24.6.2019




25.6.2019


Striascan


ioflupane (123I)


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


EU/1/19/1372


Solution for injection


V09AB03


27.6.2019




28.6.2019


LIBTAYO


cemiplimab


Regeneron Ireland U.C.
Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland


EU/1/19/1376


Concentrate for solution for infusion


Pending


2.7.2019










—



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




6.6.2019


Actos


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


EU/1/00/150


11.6.2019




6.6.2019


Advate


Baxter AG
Industriestraße 67, 1221 Wien, Österreich


EU/1/03/271


11.6.2019




6.6.2019


Alpivab


BioCryst UK Ltd
c/o Morgan Lewis & Bockius, Condor House, 5 -10 St. Paul's Churchyard, London EC4M 8AL, United Kingdom


EU/1/18/1269


10.6.2019




6.6.2019


Ammonaps


Immedica Pharma AB
Norrtullsgatan 15, SE-113 29, Stockholm, Sverige


EU/1/99/120


10.6.2019




6.6.2019


Axura


Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland


EU/1/02/218


11.6.2019




6.6.2019


Azilect


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


EU/1/04/304


11.6.2019




6.6.2019


Azopt


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


EU/1/00/129


10.6.2019




6.6.2019


Betaferon


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/95/003


11.6.2019




6.6.2019


Byetta


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/06/362


10.6.2019




6.6.2019


Clopidogrel TAD


TAD Pharma GmbH
Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland


EU/1/09/555


11.6.2019




6.6.2019


Descovy


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/16/1099


10.6.2019




6.6.2019


Effentora


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


EU/1/08/441


11.6.2019




6.6.2019


Envarsus


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


EU/1/14/935


10.6.2019




6.6.2019


Extavia


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


EU/1/08/454


10.6.2019




6.6.2019


Farydak


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


EU/1/15/1023


10.6.2019




6.6.2019


Febuxostat Mylan


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


EU/1/17/1194


11.6.2019




6.6.2019


Genvoya


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/15/1061


10.6.2019




6.6.2019


Giotrif


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


EU/1/13/879


11.6.2019




6.6.2019


Glubrava


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


EU/1/07/421


11.6.2019




6.6.2019


Glyxambi


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


EU/1/16/1146


11.6.2019




6.6.2019


Grepid


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


EU/1/09/535


10.6.2019




6.6.2019


Harvoni


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/14/958


10.6.2019




6.6.2019


Ilaris


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


EU/1/09/564


10.6.2019




6.6.2019


Imlygic


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


EU/1/15/1064


11.6.2019




6.6.2019


Invega


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


EU/1/07/395


11.6.2019




6.6.2019


Nexavar


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/06/342


11.6.2019




6.6.2019


Odefsey


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/16/1112


10.6.2019




6.6.2019


Protaphane


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


EU/1/02/234


11.6.2019




6.6.2019


Ravicti


Immedica Pharma AB
SE-113 29 Stockholm, Sverige


EU/1/15/1062


10.6.2019




6.6.2019


Rilutek


Sanofi Mature IP
54 Rue de la Boetie, 75008, Paris, FRANCE


EU/1/96/010


11.6.2019




6.6.2019


Synjardy


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


EU/1/15/1003


11.6.2019




6.6.2019


Temozolomide HEXAL


Hexal AG
Industriestraße 25, 83607 Holzkirchen, Deutschland


EU/1/10/616


11.6.2019




6.6.2019


Temozolomide Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/10/617


11.6.2019




6.6.2019


Translarna


PTC Therapeutics International Limited
5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland


EU/1/13/902


10.6.2019




6.6.2019


Veltassa


Vifor Fresenius Medical Care Renal Pharma France
100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France


EU/1/17/1179


11.6.2019




6.6.2019


Vosevi


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/17/1223


10.6.2019




6.6.2019


Zebinix


Bial - Portela & Ca, SA
À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal


EU/1/09/514


11.6.2019




12.6.2019


Accofil


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


EU/1/14/946


14.6.2019




12.6.2019


Aldara


Meda AB
Pipers väg 2A, 170 73 Solna, Sverige


EU/1/98/080


14.6.2019




12.6.2019


Gardasil


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/357


14.6.2019




12.6.2019


Lucentis


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


EU/1/06/374


14.6.2019




12.6.2019


Lynparza


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/14/959


14.6.2019




12.6.2019


Olanzapine Apotex


Apotex Europe B.V.
Archimedesweg 2, 2333 CN, Leiden, Nederland


EU/1/10/635


14.6.2019




12.6.2019


Temomedac


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


EU/1/09/605


14.6.2019




12.6.2019


Votubia


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


EU/1/11/710


14.6.2019




18.6.2019


Sialanar


Proveca Pharma Limited
Marine House, Clanwilliam Place, Dublin 2, Ireland


EU/1/16/1135


20.6.2019




18.6.2019


Telzir


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


EU/1/04/282


1.7.2019




20.6.2019


Azarga


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


EU/1/08/482


25.6.2019




20.6.2019


Bavencio


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/17/1214


25.6.2019




20.6.2019


Busulfan Fresenius Kabi


Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland


EU/1/14/951


25.6.2019




20.6.2019


Eurartesim


Alfasigma S.p.A.
Via Ragazzi del '99, n.5, 40133 Bologna, Italia


EU/1/11/716


25.6.2019




20.6.2019


Moventig


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


EU/1/14/962


25.6.2019




20.6.2019


Ocrevus


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


EU/1/17/1231


25.6.2019




20.6.2019


Palonosetron Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België


EU/1/16/1100


24.6.2019




20.6.2019


Potactasol


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


EU/1/10/660


24.6.2019




20.6.2019


Saxenda


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


EU/1/15/992


25.6.2019




20.6.2019


Skilarence


Almirall, S.A.
Ronda General Mitre, 151, 08022 Barcelona, España


EU/1/17/1201


25.6.2019




20.6.2019


Triumeq


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


EU/1/14/940


25.6.2019




20.6.2019


Zejula


TESARO Bio Netherlands B.V.
Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht,Nederland


EU/1/17/1235


24.6.2019




25.6.2019


Cuprior


gmp-orphan SA
Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France


EU/1/17/1199


27.6.2019




25.6.2019


IMBRUVICA


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


EU/1/14/945


27.6.2019




25.6.2019


Neofordex


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


EU/1/15/1053


27.6.2019




28.6.2019


Brintellix


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


EU/1/13/891


2.7.2019




28.6.2019


Darzalex


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


EU/1/16/1101


2.7.2019




28.6.2019


Docetaxel Kabi


Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland


EU/1/12/770


2.7.2019




28.6.2019


Mysimba


Orexigen Therapeutics Ireland Limited
2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland


EU/1/14/988


2.7.2019




28.6.2019


TOBI Podhaler


Mylan IRE Healthcare Ltd
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland


EU/1/10/652


2.7.2019




28.6.2019


Venclyxto


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/16/1138


2.7.2019




28.6.2019


Xgeva


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


EU/1/11/703


2.7.2019










—



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




6.6.2019


Clopidogrel HCS


HCS bvba
H. Kennisstraat 53, 2650 Edegem, België


EU/1/10/651


11.6.2019




6.6.2019


Ketek


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


EU/1/01/191


11.6.2019




25.6.2019


Palonosetron Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België


EU/1/16/1100


27.6.2019










—



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




19.6.2019


HorStem


equine umbilical cord mesenchymal stem cells


EquiCord-YMAS S.L.
103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España


EU/2/18/226


Suspension for injection


Pending


21.6.2019










—



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




13.6.2019


Nobilis IB Primo QX


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


EU/2/14/174


17.6.2019




18.6.2019


Suvaxyn PRRS MLV


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


EU/2/17/215


20.6.2019










—



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




18.6.2019


Bovalto Ibraxion


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/99/017


20.6.2019




18.6.2019


Ingelvac PCV FLEX


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


EU/2/17/208


21.6.2019




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




Domenico Scarlattilaan 6




1083 HS Amsterdam




The Netherlands






(1)  OJ L 136, 30.4.2004, p. 1.