Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-08-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2020285EN.01000101.xml










28.8.2020   


EN


Official Journal of the European Union


C 285/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 285/01)
—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




1.7.2020


Mvabea


Ebola vaccine (MVA-BN-Filo [recombinant])


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


EU/1/20/1445


Suspension for injection


J07BX02


6.7.2020




1.7.2020


Zabdeno


Ebola vaccine (Ad26.ZEBOV-GP [recombinant])


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


EU/1/20/1444


Suspension for injection


J07BX02


6.7.2020




3.7.2020


Enerzair Breezhaler


indacaterol/glycopyrronium/mometasone furoate


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


EU/1/20/1438


Inhalation powder, hard capsule


R03AL12


6.7.2020




3.7.2020


Veklury


remdesivir


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


EU/1/20/1459


Concentrate for solution for infusion
Powder for concentrate for solution for infusion


Pending


3.7.2020




3.7.2020


Zimbus Breezhaler


indacaterol/glycopyrronium/mometasone furoate


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


EU/1/20/1440


Inhalation powder, hard capsule


R03AL12


6.7.2020




23.7.2020


Apixaban Accord


apixaban


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


EU/1/20/1458


Film-coated tablet


B01AF02


27.7.2020




27.7.2020


Piqray


alpelisib


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


EU/1/20/1455


Film-coated tablet


L01XX65


28.7.2020




27.7.2020


Xenleta


lefamulin


Nabriva Therapeutics Ireland DAC
Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland


EU/1/20/1457


Film-coated tablet


J01XX12


28.7.2020




27.7.2020


Zercepac


trastuzumab


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


EU/1/20/1456


Powder for concentrate for solution for infusion


L01XC03


28.7.2020




31.7.2020


Hepcludex


bulevirtide


Myr GmbH
Hessenring 89, 61348 Bad Homburg, Deutschland


EU/1/20/1446


Powder for solution for injection


J05AX28


5.8.2020




31.7.2020


Pretomanid FGK


pretomanid


FGK Representative Service GmbH
Heimeranstraße 35, 80339 München, Deutschland


EU/1/20/1437


Tablet


Pending


4.8.2020




31.7.2020


Rozlytrek


entrectinib


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


EU/1/20/1460


Capsule, hard


L01XE56


3.8.2020




—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




6.7.2020


Hopveus


D&A PHARMA
18 Rue Saint Matthieu, 78550 Houdan, France


—


8.7.2020




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




3.7.2020


Brintellix


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


EU/1/13/891


7.7.2020




3.7.2020


Capecitabine Accord


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


EU/1/12/762


6.7.2020




3.7.2020


Capecitabine Teva


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


EU/1/12/761


6.7.2020




3.7.2020


Ecansya


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


EU/1/12/763


6.7.2020




3.7.2020


Exforge


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


EU/1/06/370


6.7.2020




3.7.2020


Harvoni


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


EU/1/14/958


7.7.2020




3.7.2020


Hetlioz


Vanda Pharmaceuticals Germany GmbH
Französische Str. 12, c/o Satellite Office, 10117 Berlin, Deutschland


EU/1/15/1008


6.7.2020




3.7.2020


Imatinib Teva


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


EU/1/12/808


6.7.2020




3.7.2020


Insulatard


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


EU/1/02/233


6.7.2020




3.7.2020


Lemtrada


Sanofi Belgium
Leonardo Da Vincilaan 19, B-1831 Diegem, België


EU/1/13/869


13.7.2020




3.7.2020


Lynparza


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/14/959


7.7.2020




3.7.2020


Mixtard


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


EU/1/02/231


6.7.2020




3.7.2020


Mysimba


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


EU/1/14/988


7.7.2020




3.7.2020


Pregabalin Accord


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


EU/1/15/1027


7.7.2020




3.7.2020


PREVYMIS


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


EU/1/17/1245


7.7.2020




3.7.2020


Protaphane


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


EU/1/02/234


6.7.2020




3.7.2020


Suboxone


Indivior Europe Limited
27 Windsor Place, Dublin 2, Ireland


EU/1/06/359


6.7.2020




3.7.2020


Teysuno


Nordic Group B.V.
Siriusdreef 41, 2132 WT Hoofddorp, Nederland


EU/1/11/669


7.7.2020




3.7.2020


Xeloda


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


EU/1/00/163


6.7.2020




6.7.2020


Capecitabine medac


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


EU/1/12/802


7.7.2020




6.7.2020


Kolbam


Retrophin Europe Limited
Palmerston House, Fenian Street, Dublin 2, Ireland


EU/1/13/895


17.7.2020




6.7.2020


Picato


LEO Laboratories Ltd
285 Cashel Road, Crumlin, Dublin 12, Ireland


EU/1/12/796


8.7.2020




13.7.2020


Aripiprazole Accord


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


EU/1/15/1045


15.7.2020




13.7.2020


BiResp Spiromax


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


EU/1/14/921


16.7.2020




13.7.2020


DuoResp Spiromax


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


EU/1/14/920


16.7.2020




13.7.2020


Kisqali


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


EU/1/17/1221


15.7.2020




13.7.2020


Lonquex


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


EU/1/13/856


16.7.2020




13.7.2020


Mulpleo


Shionogi B.V.
Kingsfordweg 151, 1043 GR Amsterdam, Nederland


EU/1/18/1348


17.7.2020




13.7.2020


Namuscla


Lupin Europe GmbH
Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland


EU/1/18/1325


15.7.2020




13.7.2020


Ofev


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


EU/1/14/979


15.7.2020




13.7.2020


Tracleer


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


EU/1/02/220


14.7.2020




16.7.2020


Capecitabine medac


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


EU/1/12/802


22.7.2020




16.7.2020


Dukoral


Valneva Sweden AB
105 21 Stockholm, Sverige


EU/1/03/263


23.7.2020




16.7.2020


Toviaz


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


EU/1/07/386


17.7.2020




17.7.2020


Capecitabine Accord


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


EU/1/12/762


23.7.2020




17.7.2020


Capecitabine Teva


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


EU/1/12/761


21.7.2020




17.7.2020


Filgrastim Hexal


Hexal AG
Industriestraße 25, 83607 Holzkirchen, Deutschland


EU/1/08/496


23.7.2020




17.7.2020


IMBRUVICA


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


EU/1/14/945


22.7.2020




17.7.2020


Imlygic


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


EU/1/15/1064


27.7.2020




17.7.2020


Silodyx


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


EU/1/09/607


27.7.2020




17.7.2020


Vihuma


Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm, Sverige


EU/1/16/1168


30.7.2020




23.7.2020


ADCETRIS


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


EU/1/12/794


27.7.2020




23.7.2020


Bavencio


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


EU/1/17/1214


27.7.2020




23.7.2020


Besponsa


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


EU/1/17/1200


24.7.2020




23.7.2020


Ciambra


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


EU/1/15/1055


27.7.2020




23.7.2020


Dectova


GlaxoSmithKline Trading Services Limited
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland


EU/1/18/1349


28.7.2020




23.7.2020


Emtricitabine/Tenofovir disoproxil Krka


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


EU/1/16/1151


30.7.2020




23.7.2020


Nordimet


Nordic Group B.V.
Siriusdreef 41, 2132 WT Hoofddorp, Nederland


EU/1/16/1124


28.7.2020




23.7.2020


Omidria


Omeros Ireland Limited
Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland


EU/1/15/1018


27.7.2020




23.7.2020


Translarna


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


EU/1/13/902


24.7.2020




23.7.2020


Vargatef


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


EU/1/14/954


24.7.2020




23.7.2020


Votubia


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


EU/1/11/710


24.7.2020




23.7.2020


VPRIV


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


EU/1/10/646


24.7.2020




24.7.2020


Remsima


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/13/853


27.7.2020




27.7.2020


APTIVUS


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


EU/1/05/315


28.7.2020




27.7.2020


Buccolam


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


EU/1/11/709


29.7.2020




27.7.2020


Cimzia


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


EU/1/09/544


5.8.2020




27.7.2020


Duzallo


Grünenthal GmbH
Zieglerstraße 6, 52078, Aachen, Deutschland


EU/1/18/1300


28.7.2020




27.7.2020


Flucelvax Tetra


Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands


EU/1/18/1326


29.7.2020




27.7.2020


Fluenz Tetra


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/887


6.8.2020




27.7.2020


Iclusig


Incyte Biosciences Distribution B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/13/839


4.8.2020




27.7.2020


Imfinzi


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/18/1322


29.7.2020




27.7.2020


Nerlynx


Pierre Fabre Médicament
45, place Abel Gance, 92100 Boulogne-Billancourt, France


EU/1/18/1311


28.7.2020




27.7.2020


Nuwiq


Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm, Sverige


EU/1/14/936


4.8.2020




27.7.2020


Orphacol


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


EU/1/13/870


29.7.2020




27.7.2020


Praxbind


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


EU/1/15/1056


28.7.2020




27.7.2020


Rilutek


Sanofi Mature IP
54 rue La Boétie, 75008, Paris, France


EU/1/96/010


28.7.2020




27.7.2020


Votrient


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


EU/1/10/628


28.7.2020




31.7.2020


Cinryze


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


EU/1/11/688


4.8.2020




31.7.2020


Cosentyx


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


EU/1/14/980


4.8.2020




31.7.2020


Evista


SUBSTIPHARM
24 rue Erlanger, 75016 Paris, France


EU/1/98/073


4.8.2020




31.7.2020


Exjade


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


EU/1/06/356


4.8.2020




31.7.2020


LIBTAYO


Regeneron Ireland Designated Activity Company (DAC)
Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland


EU/1/19/1376


4.8.2020




31.7.2020


Olanzapine Teva


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


EU/1/07/427


3.8.2020




31.7.2020


Qutenza


Grünenthal GmbH
Zieglerstraße 6, 52078, Aachen, Deutschland


EU/1/09/524


4.8.2020




31.7.2020


Retacrit


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


EU/1/07/431


4.8.2020




31.7.2020


Ruxience


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


EU/1/20/1431


4.8.2020




31.7.2020


Xolair


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


EU/1/05/319


4.8.2020




—   Withdrawal of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




13.7.2020


Kolbam


Retrophin Europe Limited
Palmerston House, Fenian Street, Dublin 2, Ireland


EU/1/13/895


15.7.2020




16.7.2020


Zurampic


Grünenthal GmbH
Zieglerstraße 6, 52078, Aachen, Deutschland


EU/1/15/1080


31.7.2020




31.7.2020


Duzallo


Grünenthal GmbH
Zieglerstraße 6, 52078, Aachen, Deutschland


EU/1/18/1300


31.7.2020




—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




20.7.2020


PREVEXXION RN


Marek’s disease vaccine (live recombinant)


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


EU/2/20/254


Concentrate and solvent for suspension for injection


QI01AD03


23.7.2020




20.7.2020


PREVEXXION RN+HVT+IBD


Infectious bursal disease and Marek’s disease vaccine (live recombinant)


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


EU/2/20/255


Concentrate and solvent for suspension for injection


QI01AD15


23.7.2020




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




1.7.2020


Leucofeligen FeLV/RCP


VIRBAC
1ère avenue 2065 m LID, 06516 Carros, France


EU/2/09/097


10.7.2020




1.7.2020


Rheumocam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/07/078


13.7.2020




1.7.2020


Zulvac 1 + 8 Bovis


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


EU/2/12/139


2.7.2020




20.7.2020


FORTEKOR PLUS


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


EU/2/15/185


23.7.2020




20.7.2020


Rabitec


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


EU/2/17/219


23.7.2020




20.7.2020


Vectormune ND


CEVA-Phylaxia Co. Ltd
Szállás u. 5, 1107 Budapest, Magyarország


EU/2/15/188


24.7.2020




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




NETHERLANDS






(1)  OJ L 136, 30.4.2004, p. 1.