Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2021 to 31 July 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-08-27
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_2021346EN.01000501.xml










27.8.2021   


EN


Official Journal of the European Union


C 346/5






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2021 to 31 July 2021
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2021/C 346/02)
—   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




16.7.2021


Bylvay


odevixibat







Albireo AB




Arvid Wallgrens Backe 20, 413 46 Gothenburg, Sverige






EU/1/21/1566


Capsule, hard


A05AX05


19.7.2021




16.7.2021


Icatibant Accord


icatibant







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/21/1567


Solution for injection


B06AC02


20.7.2021




16.7.2021


Imcivree


setmelanotide







Rhythm Pharmaceuticals Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland






EU/1/21/1564


Solution for injection in a vial


A08AA12


19.7.2021




16.7.2021


Klisyri


tirbanibulin







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/21/1558


Ointment


D06BX03


19.7.2021




16.7.2021


Ryeqo


relugolix/estradiol/norethisterone acetate







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1565


Film-coated tablet


H01CC54


20.7.2021




16.7.2021


Skysona


elivaldogene autotemcel







bluebird bio (Netherlands) B.V.




Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland






EU/1/21/1563


Dispersion for infusion


Pending


19.7.2021




16.7.2021


Verquvo


vericiguat







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/21/1561


Film-coated tablet


C01DX22


20.7.2021




—   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




1.7.2021


alli







GlaxoSmithKline Dungarvan Limited




Knockbrack, Dungarvan, Co. Waterford, Ireland






EU/1/07/401


12.7.2021




1.7.2021


Bexsero







GlaxoSmithKline Vaccines S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/12/812


12.7.2021




1.7.2021


Erivedge







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/13/848


5.7.2021




1.7.2021


Synagis







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/99/117


1.7.2021




1.7.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


1.7.2021




5.7.2021


Busulfan Fresenius Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/14/951


8.7.2021




5.7.2021


Icandra







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/08/484


6.7.2021




5.7.2021


Ilumetri







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/18/1323


6.7.2021




5.7.2021


Lamzede







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/17/1258


7.7.2021




5.7.2021


Nilemdo







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1425


16.7.2021




5.7.2021


Nuwiq







Octapharma AB




Lars Forssells gata 23, 112 75 Stockholm, Sverige






EU/1/14/936


6.7.2021




5.7.2021


Rasilez HCT







Noden Pharma DAC




D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland






EU/1/08/491


6.7.2021




5.7.2021


Trydonis







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/18/1274


6.7.2021




5.7.2021


Voriconazole Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/13/835


6.7.2021




5.7.2021


Zomarist







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/08/483


6.7.2021




9.7.2021


Anagrelide Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/17/1256


16.7.2021




9.7.2021


Clopidogrel Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/08/465


12.7.2021




9.7.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


9.7.2021




9.7.2021


Imraldi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1216


14.7.2021




9.7.2021


Levetiracetam Hospira







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België






EU/1/13/889


13.7.2021




9.7.2021


ProQuad







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/05/323


12.7.2021




9.7.2021


Qutenza







Grünenthal GmbH




Zieglerstraße 6, 52078, Aachen, Deutschland






EU/1/09/524


19.7.2021




9.7.2021


Steglatro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1267


12.7.2021




9.7.2021


Zynteglo







bluebird bio (Netherlands) B.V.




Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland






EU/1/19/1367


18.7.2021




13.7.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


13.7.2021




13.7.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


13.7.2021




16.7.2021


Bevespi Aerosphere







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1339


19.7.2021




16.7.2021


Bridion







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/466


26.7.2021




16.7.2021


Brintellix







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/13/891


20.7.2021




16.7.2021


Cosentyx







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/14/980


22.7.2021




16.7.2021


Emgality







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1330


20.7.2021




16.7.2021


Emtricitabine/Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1148


24.7.2021




16.7.2021


Evicel







Omrix Biopharmaceuticals N.V.




Leonardo Da Vincilaan 15, 1831 Diegem, België






EU/1/08/473


2.8.2021




16.7.2021


IBRANCE







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België






EU/1/16/1147


20.7.2021




16.7.2021


Idefirix







Hansa Biopharma AB




P.O. Box 785, 220 07 Lund, Sverige






EU/1/20/1471


21.7.2021




16.7.2021


Irbesartan Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/06/376


24.7.2021




16.7.2021


Onivyde pegylated liposomal







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/16/1130


19.7.2021




16.7.2021


Rapamune







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België






EU/1/01/171


20.7.2021




16.7.2021


Rekovelle







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark






EU/1/16/1150


20.7.2021




16.7.2021


Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1127


24.7.2021




16.7.2021


Thalidomide Celgene







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/08/443


20.7.2021




16.7.2021


Vectibix







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/07/423


2.8.2021




16.7.2021


XALKORI







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België






EU/1/12/793


20.7.2021




16.7.2021


Zejula







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1235


19.7.2021




19.7.2021


Beovu







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/19/1417


20.7.2021




19.7.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


19.7.2021




23.7.2021


Actos







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/00/150


28.7.2021




23.7.2021


Afinitor







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/09/538


26.7.2021




23.7.2021


AUBAGIO







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/13/838


26.7.2021




23.7.2021


AYVAKYT







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/20/1473


5.8.2021




23.7.2021


Beromun







BELPHARMA s.a.




2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg






EU/1/99/097


27.7.2021




23.7.2021


Bortezomib Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/15/1019


28.7.2021




23.7.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


23.7.2021




23.7.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


23.7.2021




23.7.2021


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


26.7.2021




23.7.2021


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


27.7.2021




23.7.2021


Fluenz Tetra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/887


26.7.2021




23.7.2021


Ibandronic Acid Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/642


26.7.2021




23.7.2021


Ilaris







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/09/564


26.7.2021




23.7.2021


Ivemend







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/437


26.7.2021




23.7.2021


Lamivudine Teva Pharma B.V.







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/596


26.7.2021




23.7.2021


Mekinist







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/14/931


26.7.2021




23.7.2021


Senshio







Shionogi B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Nederland






EU/1/14/978


27.7.2021




23.7.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


23.7.2021




28.7.2021


Deferiprone Lipomed







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/18/1310


29.7.2021




28.7.2021


Insulin lispro Sanofi







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1203


29.7.2021




28.7.2021


Jakavi







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/12/773


29.7.2021




28.7.2021


Lorviqua







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België






EU/1/19/1355


29.7.2021




28.7.2021


OPDIVO







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/15/1014


29.7.2021




—   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




19.7.2021


Glidipion







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/12/756


20.7.2021




23.7.2021


Lumoxiti







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1522


1.8.2021




—   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




13.7.2021


Bonqat


pregabalin







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/21/273


Oral solution


QN03AX16


14.7.2021




—   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




13.7.2021


Clomicalm







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/98/007


16.7.2021




13.7.2021


Naxcel







Zoetis Belgium S.A.




rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique






EU/2/05/053


15.7.2021




20.7.2021


Arti-Cell Forte







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/18/228


22.7.2021




26.7.2021


Arti-Cell Forte







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/18/228


27.7.2021




30.7.2021


Loxicom







Norbrook Laboratories (Ireland) Limited




Rossmore Industrial Estate, Monaghan, Ireland






EU/2/08/090


3.8.2021




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.