Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022 (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: 2022-11-30
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








C_2022457EN.01000101.xml










30.11.2022   


EN


Official Journal of the European Union


C 457/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022
(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))
(2022/C 457/01)
—   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




3.10.2022


Spikevax


elasomeran







MODERNA BIOTECH SPAIN, S.L.




Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España






EU/1/20/1507


dispersion for injection


J07BX03


5.10.2022




10.10.2022


Comirnaty


tozinameran, COVID-19 mRNA vaccine (nucleoside-modified)







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


Concentrate for dispersion for injection
dispersion for injection


J07BX03


10.10.2022




31.10.2022


Beyfortus


nirsevimab







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1689


Solution for injection


J06BD08


3.11.2022




31.10.2022


Vaxzevria


COVID-19 Vaccine (ChAdOx1-S [recombinant])







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


Suspension for injection


J07BX03


31.10.2022




—   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




3.10.2022


Genvoya







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/15/1061


4.10.2022




3.10.2022


Nuvaxovid







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


5.10.2022




7.10.2022


Byfavo







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/20/1505


13.10.2022




7.10.2022


Pirfenidone axunio







axunio Pharma GmbH




Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland






EU/1/22/1655


13.10.2022




7.10.2022


Sunosi







TMC Pharma (EU) Limited




7a Durands Court, 45 Parnell Street, Waterford, Co. Waterford, X91 P381, Ireland






EU/1/19/1408


10.10.2022




12.10.2022


Aripiprazole Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1029


13.10.2022




14.10.2022


Adtralza







Leo Pharma A/S




Industriparken 55, 2750 Ballerup, Danmark






EU/1/21/1554


19.10.2022




14.10.2022


ALPROLIX







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/16/1098


18.10.2022




14.10.2022


Alunbrig







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/18/1264


17.10.2022




14.10.2022


ARIKAYCE liposomal







Insmed Netherlands B.V.




Stadsplateau 7, 3521 AZ Utrecht, Nederland






EU/1/20/1469


6.11.2022




14.10.2022


Bexsero







GlaxoSmithKline Vaccines S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/12/812


17.10.2022




14.10.2022


Cegfila







Mundipharma Corporation (Ireland) Limited




Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland






EU/1/19/1409


19.10.2022




14.10.2022


Cystagon







Recordati Rare Diseases




Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France






EU/1/97/039


17.10.2022




14.10.2022


Drovelis







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1547


17.10.2022




14.10.2022


Dzuveo







Laboratoire Aguettant




1 Rue Alexander Fleming, 69007 Lyon, France






EU/1/18/1284


17.10.2022




14.10.2022


ELZONRIS







Stemline Therapeutics B.V.




Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland






EU/1/20/1504


18.10.2022




14.10.2022


Empliciti







Bristol-Myers Squibb Pharma EEIG




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






EU/1/16/1088


17.10.2022




14.10.2022


Entacapone Orion







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/11/708


17.10.2022




14.10.2022


Icandra







Novartis Europharm Limited




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






EU/1/08/484


18.10.2022




14.10.2022


Imlygic







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1064


17.10.2022




14.10.2022


Imnovid







Bristol Myers Squibb Pharma EEIG




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






EU/1/13/850


17.10.2022




14.10.2022


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


17.10.2022




14.10.2022


Nepexto







Mylan IRE Healthcare Limited




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






EU/1/20/1436


17.10.2022




14.10.2022


Nevanac







Novartis Europharm Limited




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






EU/1/07/433


17.10.2022




14.10.2022


Nilemdo







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1425


18.11.2022




14.10.2022


Nustendi







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1424


20.10.2022




14.10.2022


Omnitrope







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/06/332


17.10.2022




14.10.2022


Ovitrelle







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/00/165


17.10.2022




14.10.2022


Pergoveris







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/07/396


17.10.2022




14.10.2022


Revlimid







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/391


17.10.2022




14.10.2022


Revolade







Novartis Europharm Limited




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






EU/1/10/612


17.10.2022




14.10.2022


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


17.10.2022




14.10.2022


Vectibix







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/07/423


17.10.2022




14.10.2022


Xolair







Novartis Europharm Limited




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






EU/1/05/319


17.10.2022




14.10.2022


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


17.10.2022




14.10.2022


Zomarist







Novartis Europharm Limited




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






EU/1/08/483


17.10.2022




20.10.2022


Anagrelide Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1256


21.10.2022




20.10.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


20.10.2022




20.10.2022


Dynastat







Pfizer Europe MA EEIG




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






EU/1/02/209


21.10.2022




20.10.2022


Evra







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/02/223


25.10.2022




20.10.2022


Orkambi







Vertex Pharmaceuticals (Ireland) Limited




Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland






EU/1/15/1059


21.10.2022




20.10.2022


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


21.10.2022




20.10.2022


Rapamune







Pfizer Europe MA EEIG




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






EU/1/01/171


21.10.2022




20.10.2022


Rezolsta







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/967


21.10.2022




20.10.2022


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España






EU/1/20/1507


20.10.2022




20.10.2022


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


20.10.2022




20.10.2022


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


20.10.2022




20.10.2022


Xelevia







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/382


24.10.2022




21.10.2022


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


24.10.2022




21.10.2022


Inflectra







Pfizer Europe MA EEIG




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






EU/1/13/854


24.10.2022




21.10.2022


Vaxneuvance







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/21/1591


24.10.2022




28.10.2022


Brukinsa







BeiGene Ireland Limited




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






EU/1/21/1576


3.11.2022




28.10.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


28.10.2022




28.10.2022


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


3.11.2022




28.10.2022


REKAMBYS







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1482


2.11.2022




28.10.2022


VPRIV







Takeda Pharmaceuticals International AG Ireland Branch




Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland






EU/1/10/646


2.11.2022




28.10.2022


XALKORI







Pfizer Europe MA EEIG




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






EU/1/12/793


2.11.2022




31.10.2022


Adasuve







Ferrer Internacional S.A.




Gran Via Carlos III, 94 08028 Barcelona, España






EU/1/13/823


7.11.2022




31.10.2022


JCOVDEN







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


2.11.2022




31.10.2022


Ofev







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/979


3.11.2022




31.10.2022


Pregabalin Mylan







Mylan Pharmaceuticals Limited




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






EU/1/15/997


3.11.2022




31.10.2022


Rivastigmine HEXAL







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/09/589


8.11.2022




31.10.2022


RXULTI







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/18/1294


7.11.2022




31.10.2022


Tafinlar







Novartis Europharm Limited




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






EU/1/13/865


3.11.2022




31.10.2022


Zercepac







Accord Healthcare S.L.U.




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






EU/1/20/1456


3.11.2022




—   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




7.10.2022


Improvac







Zoetis Belgium S.A.




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






EU/2/09/095


10.10.2022




7.10.2022


Rabitec







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/219


10.10.2022




7.10.2022


Tulinovet







V.M.D.n.v.




Hoge Mauw 900, 2370 Arendonk, Belgïe






EU/2/20/257


14.10.2022




7.10.2022


Virbagen Omega







VIRBAC




1ère Avenue — 2065m — L.I.D., 06516 CARROS, France






EU/2/01/030


10.10.2022




17.10.2022


Bonqat







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/21/273


19.10.2022




17.10.2022


Bovilis Blue-8







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/218


18.10.2022




17.10.2022


Chanhold







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/19/236


18.10.2022




17.10.2022


CLYNAV







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/197


18.10.2022




17.10.2022


Easotic







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/08/085


19.10.2022




17.10.2022


EVICTO







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/19/242


18.10.2022




17.10.2022


MHYOSPHERE PCV ID







Laboratorios Hipra, S.A.




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






EU/2/20/259


18.10.2022




17.10.2022


Nobivac LeuFel







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/17/217


18.10.2022




17.10.2022


Poulvac E. coli







Zoetis Belgium S.A.




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






EU/2/12/140


18.10.2022




17.10.2022


Rabigen SAG2







VIRBAC S.A.




1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France






EU/2/00/021


19.10.2022




25.10.2022


EVICTO







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/19/242


26.10.2022




25.10.2022


Exzolt







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/212


26.10.2022




25.10.2022


Solensia







Zoetis Belgium SA




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






EU/2/20/269


26.10.2022




28.10.2022


Improvac







Zoetis Belgium S.A.




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






EU/2/09/095


2.11.2022




28.10.2022


Improvac







Zoetis Belgium S.A.




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






EU/2/09/095


2.11.2022




28.10.2022


Porcilis PCV M Hyo







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/14/175


1.11.2022




28.10.2022


PREVEXXION RN







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/254


2.11.2022




28.10.2022


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


2.11.2022




28.10.2022


Purevax RCPCh







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/050


2.11.2022




28.10.2022


Vaxxitek HVT + IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/02/032


2.11.2022




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.