Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2023 to 30 June 2023 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2023-07-31
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_2023269EN.01000101.xml










31.7.2023   


EN


Official Journal of the European Union


C 269/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2023 to 30 June 2023
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))
(2023/C 269/01)
—   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




6.6.2023


Arexvy


Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/23/1740


Powder and suspension for suspension for injection


Pending


9.6.2023




23.6.2023


Sugammadex Piramal


sugammadex







Piramal Critical Care B.V.




Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland






EU/1/23/1739


Solution for injection


V03AB35


28.6.2023




26.6.2023


CAMZYOS


mavacamten







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1716


Capsule, hard


C01EB


27.6.2023




26.6.2023


Opfolda


miglustat







Amicus Therapeutics Europe Limited




Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland






EU/1/23/1737


Capsule, hard


A16AX06


27.6.2023










—



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




1.6.2023


Luminity







Lantheus EU Limited




Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland






EU/1/06/361


5.6.2023




5.6.2023


Bimzelx







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/21/1575


6.6.2023




5.6.2023


Slenyto







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/18/1318


10.6.2023




5.6.2023


Vyxeos liposomal







Jazz Pharmaceuticals Ireland Ltd




5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland






EU/1/18/1308


6.6.2023




8.6.2023


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


9.6.2023




8.6.2023


Clopidogrel ratiopharm







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/14/975


12.6.2023




8.6.2023


Doptelet







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/19/1373


13.6.2023




8.6.2023


Flixabi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/16/1106


13.6.2023




8.6.2023


Kengrexal







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/15/994


9.6.2023




8.6.2023


Ondexxya







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1345


13.6.2023




8.6.2023


Oxbryta







Pfizer Europe MA EEIG




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






EU/1/21/1622


19.6.2023




8.6.2023


Rubraca







zr pharma& GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/17/1250


9.6.2023




8.6.2023


Sildenafil ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/09/603


15.6.2023




8.6.2023


Zoledronic acid Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/12/786


9.6.2023




13.6.2023


Fabrazyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/01/188


19.6.2023




13.6.2023


Lysodren







HRA Pharma Rare Diseases




200 avenue de Paris, 92320 Chatillon, France






EU/1/04/273


14.6.2023




13.6.2023


ReFacto AF







Pfizer Europe MA EEIG




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






EU/1/99/103


14.6.2023




13.6.2023


Tasigna







Novartis Europharm Limited




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






EU/1/07/422


14.6.2023




15.6.2023


Levetiracetam Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/11/713


19.6.2023




15.6.2023


Orphacol







THERAVIA




16 Rue Montrosier, 92200 Neuilly-sur-Seine, France






EU/1/13/870


19.6.2023




15.6.2023


Symtuza







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1225


16.6.2023




19.6.2023


HBVAXPRO







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/01/183


22.6.2023




19.6.2023


Modigraf







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/09/523


21.6.2023




19.6.2023


Revestive







Takeda Pharmaceuticals International AG Ireland Branch




Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland






EU/1/12/787


24.6.2023




19.6.2023


Temozolomide SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/11/697


21.6.2023




19.6.2023


Vidaza







Bristol Myers Squibb Pharma EEIG




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






EU/1/08/488


26.6.2023




19.6.2023


Votubia







Novartis Europharm Limited




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






EU/1/11/710


20.6.2023




23.6.2023


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


28.6.2023




23.6.2023


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


26.6.2023




23.6.2023


Adakveo







Novartis Europharm Limited




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






EU/1/20/1476


26.6.2023




23.6.2023


Braftovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1314


28.6.2023




23.6.2023


Cimzia







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/09/544


26.6.2023




23.6.2023


Clopidogrel Taw Pharma







Taw Pharma (Ireland) Limited




104 Lower Baggot Street, Dublin 2, Ireland






EU/1/09/559


27.6.2023




23.6.2023


Dovprela







Mylan IRE Healthcare Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/20/1437


4.7.2023




23.6.2023


Gefitinib Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/18/1321


26.6.2023




23.6.2023


GONAL-f







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/95/001


26.6.2023




23.6.2023


Jivi







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/18/1324


26.6.2023




23.6.2023


Lenalidomide Accord







Accord Healthcare S.L.U.




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






EU/1/18/1316


26.6.2023




23.6.2023


Mekinist







Novartis Europharm Limited




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






EU/1/14/931


26.6.2023




23.6.2023


Mektovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1315


28.6.2023




23.6.2023


Mycophenolate mofetil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/439


26.6.2023




23.6.2023


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


26.6.2023




23.6.2023


Pelgraz







Accord Healthcare S.L.U.




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






EU/1/18/1313


26.6.2023




23.6.2023


Verzenios







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1307


26.6.2023




23.6.2023


VEYVONDI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/18/1298


28.6.2023




23.6.2023


Ziextenzo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1327


26.6.2023




26.6.2023


Deferiprone Lipomed







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/18/1310


27.6.2023




26.6.2023


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27 Ireland






EU/1/19/1376


27.6.2023




26.6.2023


Myfenax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/438


27.6.2023




26.6.2023


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


27.6.2023




26.6.2023


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


27.6.2023




26.6.2023


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


27.6.2023




26.6.2023


Xevudy







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


27.6.2023




26.6.2023


Zelboraf







Roche Registration GmbH




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






EU/1/12/751


27.6.2023




29.6.2023


AFSTYLA







CSL Behring GmbH




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






EU/1/16/1158


4.7.2023




29.6.2023


ARIKAYCE liposomal







Insmed Netherlands B.V.




Stadsplateau 7, 3521 AZ Utrecht, Nederland






EU/1/20/1469


30.6.2023




29.6.2023


Azacitidine Mylan







Mylan Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/20/1426


30.6.2023




29.6.2023


Beovu







Novartis Europharm Limited




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






EU/1/19/1417


30.6.2023




29.6.2023


Bydureon







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/11/696


30.6.2023




29.6.2023


Clopidogrel Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/562


3.7.2023




29.6.2023


Daurismo







Pfizer Europe MA EEIG




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






EU/1/20/1451


30.6.2023




29.6.2023


Efmody







Diurnal Europe B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/21/1549


3.7.2023




29.6.2023


Ervebo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1392


3.7.2023




29.6.2023


JCOVDEN







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


30.6.2023




29.6.2023


Lenalidomide Mylan







Mylan Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/20/1490


30.6.2023




29.6.2023


Mysildecard







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1134


30.6.2023




29.6.2023


Opsumit







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/893


30.6.2023




29.6.2023


Sildenafil Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/09/595


30.6.2023




29.6.2023


Sildenafil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/584


30.6.2023




29.6.2023


Vyepti







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/21/1599


3.7.2023




29.6.2023


Xgeva







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/11/703


3.7.2023




—   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




8.6.2023


Lenalidomide Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1521


13.6.2023




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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




29.6.2023


Eluracat


capromorelin tartrate







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/23/297


Oral solution


QH01AX90


3.7.2023




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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




5.6.2023


Contacera







Zoetis Belgium




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






EU/2/12/144


8.6.2023




5.6.2023


GUMBOHATCH







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170 Amer (Girona), España






EU/2/19/245


9.6.2023




5.6.2023


Purevax RCPCh







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/050


7.6.2023




8.6.2023


Cerenia







Zoetis Belgium




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






EU/2/06/062


9.6.2023




8.6.2023


Easotic







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/08/085


14.6.2023




8.6.2023


LETIFEND







LETI Pharma, S.L.U.




C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760 Madrid, España






EU/2/16/195


9.6.2023




8.6.2023


Locatim







Biokema Europe




Centre des Affaires des Lilas, 77 Avenue des Lilas, 64000 Pau, France






EU/2/99/011


9.6.2023




8.6.2023


Onsior







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/08/089


9.6.2023




8.6.2023


PREVEXXION RN







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/254


12.6.2023




8.6.2023


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


12.6.2023




8.6.2023


Proteq West Nile







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/11/129


14.6.2023




8.6.2023


Purevax RCP







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/052


12.6.2023




8.6.2023


Purevax RCP FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/048


12.6.2023




16.6.2023


Improvac







Zoetis Belgium




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






EU/2/09/095


20.6.2023




26.6.2023


Chanaxin







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/22/283


29.6.2023




26.6.2023


Melovem







Dopharma Research B.V.




Zalmweg 24, 4941 VX Raamsdonksveer, Nederland






EU/2/09/098


29.6.2023




29.6.2023


Hiprabovis IBR Marker Live







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170 Amer (Girona), España






EU/2/10/114


3.7.2023




29.6.2023


Naxcel







Zoetis Belgium SA




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






EU/2/05/053


3.7.2023




29.6.2023


Nobivac L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/143


30.6.2023




29.6.2023


Simparica







Zoetis Belgium




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






EU/2/15/191


4.7.2023




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.

(2)  OJ L 4, 7.1.2019, p. 43.