Official Journal of the European Union

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.