Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2023 to 30 April 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: 2023-05-31
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_2023192EN.01000101.xml










31.5.2023   


EN


Official Journal of the European Union


C 192/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2023 to 30 April 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 192/01)
—   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




19.4.2023


AKEEGA


niraparib / abiraterone acetate







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/23/1722


Film-coated tablet


L01XK


20.4.2023




19.4.2023


BEKEMV


eculizumab







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/23/1727


Concentrate for solution for infusion


L04AA25


20.4.2023




19.4.2023


Opzelura


ruxolitinib







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/23/1726


Cream


D11AH09


20.4.2023




24.4.2023


Vafseo


vadadustat







AKEBIA EUROPE Limited




70 Sir John Rogerson’s Quay, Dublin 2, Co. Dublin, D02 R296, Ireland






EU/1/23/1725


Film-coated tablet


B03XA08


25.4.2023




—   Issuing of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




12.4.2023


OMBLASTYS







Y-Mabs Therapeutics A/S




Agern Alle 11, 2970 Hoersholm, Hovedstaden, Danmark






—


14.4.2023




—   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




4.4.2023


Artesunate Amivas







Amivas Ireland Limited




Durands Court 7, Parnell Street, Waterford, Ireland






EU/1/21/1582


5.4.2023




4.4.2023


Capecitabine medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/12/802


5.4.2023




4.4.2023


Deferasirox Accord







Accord Healthcare S.L.U.




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






EU/1/19/1412


6.4.2023




4.4.2023


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


5.4.2023




4.4.2023


Nuvaxovid







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


5.4.2023




4.4.2023


Onpattro







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/18/1320


11.4.2023




4.4.2023


Rybelsus







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1430


11.4.2023




4.4.2023


Siklos







Addmedica




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






EU/1/07/397


13.4.2023




12.4.2023


Fintepla







UCB Pharma S.A.




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






EU/1/20/1491


14.4.2023




12.4.2023


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


13.4.2023




12.4.2023


Xerava







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/18/1312


13.4.2023




17.4.2023


Cablivi







Ablynx N.V.




Technologiepark 21, 9052 Zwijnaarde, België






EU/1/18/1305


18.4.2023




17.4.2023


Kisplyx







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/16/1128


18.4.2023




19.4.2023


Lonquex







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/13/856


24.4.2023




19.4.2023


Lunsumio







Roche Registration GmbH




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






EU/1/22/1649


20.4.2023




19.4.2023


Tegsedi







Akcea Therapeutics Ireland Ltd




St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland






EU/1/18/1296


20.4.2023




24.4.2023


Alimta







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/04/290


25.4.2023




24.4.2023


Axumin







Blue Earth Diagnostics Ireland Ltd




6th Floor, 2 Grand Canal Square, Dublin 2, Ireland






EU/1/17/1186


28.4.2023




24.4.2023


Erbitux







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/04/281


1.5.2023




24.4.2023


Farydak







zr pharma& GmbH




Hietzinger Hauptstrasse 37, 1130 Wien, Österreich






EU/1/15/1023


25.4.2023




24.4.2023


Givlaari







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/20/1428


25.4.2023




24.4.2023


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


25.4.2023




24.4.2023


Imnovid







Bristol Myers Squibb Pharma EEIG




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






EU/1/13/850


26.4.2023




24.4.2023


Kevzara







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1196


3.5.2023




24.4.2023


Ondexxya







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1345


27.4.2023




24.4.2023


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


2.5.2023




24.4.2023


Poteligeo







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/18/1335


2.5.2023




24.4.2023


Repaglinide Accord







Accord Healthcare S.L.U.




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






EU/1/11/743


2.5.2023




24.4.2023


Tolucombi







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/13/821


25.4.2023




24.4.2023


YERVOY







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


2.5.2023




24.4.2023


Zutectra







Biotest Pharma GmbH




Landsteinerstraße 5, 63303 Dreieich, Deutschland






EU/1/09/600


25.4.2023




26.4.2023


Arsenic trioxide medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/20/1475


3.5.2023




26.4.2023


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/17/1210


27.4.2023




26.4.2023


Kymriah







Novartis Europharm Limited




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






EU/1/18/1297


27.4.2023




26.4.2023


Luxturna







Novartis Europharm Limited




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






EU/1/18/1331


27.4.2023




26.4.2023


Orkambi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/15/1059


27.4.2023




26.4.2023


Padcev







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1615


1.5.2023




26.4.2023


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


27.4.2023




26.4.2023


Vaxneuvance







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/21/1591


28.4.2023




26.4.2023


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


27.4.2023




26.4.2023


Zavicefta







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/16/1109


3.5.2023




27.4.2023


AJOVY







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/19/1358


3.5.2023




27.4.2023


Fycompa







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/12/776


28.4.2023




28.4.2023


Breyanzi







Bristol Myers Squibb Pharma EEIG




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






EU/1/22/1631


2.5.2023




28.4.2023


Cotellic







Roche Registration GmbH




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






EU/1/15/1048


2.5.2023




28.4.2023


Wegovy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/21/1608


2.5.2023




—   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




4.4.2023


Inpremzia







Baxter Holding B.V.




Kobaltweg 49, 3542 CE Utrecht, Nederland






EU/1/22/1644


5.4.2023




—   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




14.4.2023


Innovax-ILT-IBD


avian infectious laryngotracheitis, infectious bursal disease and Marek’s disease vaccine (live recombinant)







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/23/292


Concentrate and solvent for suspension for injection


QI01AD18


17.4.2023




24.4.2023


Prolevare


oclacitinib maleate







Zoetis Belgium




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






EU/2/23/295


Film-coated tablet


QD11AH90


25.4.2023




—   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




5.4.2023


Lydaxx







VETOQUINOL S.A.




Magny-Vernois, 70200 Lure, France






EU/2/20/253


11.4.2023




5.4.2023


MHYOSPHERE PCV ID







Laboratorios Hipra, S.A.




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






EU/2/20/259


12.4.2023




5.4.2023


Purevax RCP







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/052


12.4.2023




5.4.2023


Simparica Trio







Zoetis Belgium




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






EU/2/19/243


13.4.2023




5.4.2023


Versican Plus Pi/L4







Zoetis Belgium SA




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






EU/2/14/172


11.4.2023




14.4.2023


Simparica Trio







Zoetis Belgium




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






EU/2/19/243


18.4.2023




14.4.2023


Suvaxyn Circo + MH RTU







Zoetis Belgium SA




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






EU/2/15/190


19.4.2023




14.4.2023


Syvazul BTV







LABORATORIOS SYVA, S.A.U.




Av. Párroco Pablo Diez 49-57, 24010 León, España






EU/2/18/231


17.4.2023




14.4.2023


Vectormune FP ILT + AE







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/20/250


18.4.2023




14.4.2023


Zycortal







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/15/189


21.4.2023




28.4.2023


CircoMax Myco







Zoetis Belgium




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






EU/2/20/264


2.5.2023




28.4.2023


Kriptazen







Virbac




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






EU/2/18/234


5.5.2023




28.4.2023


Leucofeligen FeLV/RCP







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/09/097


4.5.2023




28.4.2023


Librela







Zoetis Belgium




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






EU/2/20/261


2.5.2023




28.4.2023


Masivet







AB Science S.A.




3 avenue George V, 75008 Paris, France






EU/2/08/087


2.5.2023




28.4.2023


Suprelorin







VIRBAC S.A.




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






EU/2/07/072


4.5.2023




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.