Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 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: 2022-05-31
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_2022215EN.01000101.xml










31.5.2022   


EN


Official Journal of the European Union


C 215/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 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 215/01)
—   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




1.4.2022


KIMMTRAK


tebentafusp







Immunocore Ireland Limited




Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland






EU/1/22/1630


Concentrate for solution for infusion


Pending


6.4.2022




4.4.2022


Breyanzi


lisocabtagene maraleucel







Bristol Myers Squibb Pharma EEIG




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






EU/1/22/1631


Dispersion for infusion


Pending


5.4.2022




7.4.2022


Bosulif


Bosutinib







Pfizer Europe MA EEIG




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






EU/1/13/818


Film-coated tablet


L01XE14


8.4.2022




13.4.2022


Padcev


enfortumab vedotin







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1615


Powder for concentrate for solution for infusion


L01FX13


19.4.2022




25.4.2022


Inpremzia


insulin human (rDNA)







Baxter Holding B.V.




Kobaltweg 49, 3542 CE Utrecht, Nederland






EU/1/22/1644


Solution for infusion


A10AB01


27.4.2022




25.4.2022


Kapruvia


difelikefalin







Vifor Fresenius Medical Care Renal Pharma France




100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France






EU/1/22/1643


Solution for injection


V03AX04


27.4.2022




25.4.2022


PreHevbri


Hepatitis B vaccine (recombinant, adsorbed)







VBI Vaccines B.V.




Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland






EU/1/22/1641


Suspension for injection


J07BC01


27.4.2022




25.4.2022


Sitagliptin Accord


Sitagliptin







Accord Healthcare S.L.U.




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






EU/1/22/1633


Film-coated tablet


A10BH01


26.4.2022




25.4.2022


Truvelog Mix 30


insulin aspart







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/22/1639


Suspension for injection


A10AD05


26.4.2022




25.4.2022


Uplizna


inebilizumab







Viela Bio B.V.




Schiphol Boulevard 359, 1118 BJ Schiphol, Nederland






EU/1/21/1602


Concentrate for solution for infusion


L04AA


29.4.2022




25.4.2022


Vydura


rimegepant







Biohaven Pharmaceutical Ireland DAC




6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland






EU/1/22/1645


Oral lyophilisate


N02CD


26.4.2022




29.4.2022


Orgovyx


relugolix







Myovant Sciences Ireland Limited




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






EU/1/22/1642


Film-coated tablet


L02BX04


4.5.2022




29.4.2022


QUVIVIQ


daridorexant







Idorsia Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/22/1638


Film-coated tablet


Pending


2.5.2022




—   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




1.4.2022


Aclasta







Novartis Europharm Limited




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






EU/1/05/308


5.4.2022




1.4.2022


Evista







SUBSTIPHARM




24 rue Erlanger, 75016 Paris, France






EU/1/98/073


20.4.2022




1.4.2022


Kyprolis







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1060


5.4.2022




1.4.2022


Naglazyme







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork P43 R298, Ireland






EU/1/05/324


6.4.2022




1.4.2022


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


4.4.2022




1.4.2022


Replagal







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/01/189


5.4.2022




1.4.2022


Revatio







Upjohn EESV




Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland






EU/1/05/318


12.4.2022




1.4.2022


RotaTeq







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/348


4.4.2022




1.4.2022


Ultomiris







Alexion Europe SAS




103-105 Rue Anatole France, 92300 Levallois-Perret, France






EU/1/19/1371


5.4.2022




1.4.2022


Verzenios







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1307


4.4.2022




1.4.2022


YERVOY







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


4.4.2022




1.4.2022


Zostavax







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/341


4.4.2022




4.4.2022


Axura







Merz Pharmaceuticals GmbH




Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland






EU/1/02/218


6.4.2022




4.4.2022


Bemrist Breezhaler







Novartis Europharm Limited




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






EU/1/20/1441


5.4.2022




4.4.2022


Capecitabine Accord







Accord Healthcare S.L.U.




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






EU/1/12/762


5.4.2022




4.4.2022


Dupixent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1229


6.4.2022




4.4.2022


Elaprase







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/06/365


19.4.2022




4.4.2022


Erelzi







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1195


5.4.2022




4.4.2022


HBVAXPRO







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/01/183


6.4.2022




4.4.2022


Incresync







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/13/842


6.4.2022




4.4.2022


Kisqali







Novartis Europharm Limited




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






EU/1/17/1221


5.4.2022




4.4.2022


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


6.4.2022




4.4.2022


Memantine Merz







Merz Pharmaceuticals GmbH




Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland






EU/1/12/799


11.4.2022




4.4.2022


MenQuadfi







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/20/1483


5.4.2022




4.4.2022


Ratiograstim







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/08/444


5.4.2022




4.4.2022


Reagila







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/17/1209


7.4.2022




4.4.2022


Shingrix







GlaxoSmithKline Biologicals S.A.




rue de l’Institut 89, 1330 Rixensart, Belgique






EU/1/18/1272


5.4.2022




4.4.2022


Tevagrastim







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/08/445


6.4.2022




4.4.2022


Vipdomet







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/13/843


6.4.2022




4.4.2022


Vipidia







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/13/844


6.4.2022




7.4.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


7.4.2022




7.4.2022


Pifeltro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1332


8.4.2022




12.4.2022


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


22.4.2022




13.4.2022


ADCETRIS







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/12/794


21.4.2022




13.4.2022


Aldara







Meda AB




Pipers väg 2A, 170 73 Solna, Sverige






EU/1/98/080


21.4.2022




13.4.2022


Evkeeza







Ultragenyx Germany GmbH




Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland






EU/1/21/1551


20.4.2022




13.4.2022


Komboglyze







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/11/731


19.4.2022




13.4.2022


M-M-RVAXPRO







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/337


19.4.2022




13.4.2022


NeuroBloc







Sloan Pharma S.a.r.l.




33 Rue de Puits Romain, 8070 Bertrange, Luxembourg






EU/1/00/166


21.4.2022




13.4.2022


Onglyza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/09/545


19.4.2022




13.4.2022


ProQuad







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/323


19.4.2022




13.4.2022


Tremfya







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1234


19.4.2022




20.4.2022


Zolgensma







Novartis Gene Therapies EU Limited




Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland






EU/1/20/1443


21.4.2022




25.4.2022


Blitzima







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/17/1205


26.4.2022




25.4.2022


Byfavo







PAION Netherlands B.V.




Vogt 21, 6422 RK Heerlen, Nederland






EU/1/20/1505


27.4.2022




25.4.2022


Fampyra







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/11/699


28.4.2022




25.4.2022


Fycompa







Eisai GmbH




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






EU/1/12/776


26.4.2022




25.4.2022


Ilumetri







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/18/1323


2.5.2022




25.4.2022


Kevzara







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1196


26.4.2022




25.4.2022


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


28.4.2022




25.4.2022


Koselugo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1552


26.4.2022




25.4.2022


Kyntheum







Leo Pharma A/S




Industriparken 55, 2750 Ballerup, Danmark






EU/1/16/1155


27.4.2022




25.4.2022


Lyumjev







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1422


28.4.2022




25.4.2022


MAVENCLAD







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1212


26.4.2022




25.4.2022


Nerlynx







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1311


26.4.2022




25.4.2022


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


28.4.2022




25.4.2022


Sogroya







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1501


27.4.2022




25.4.2022


Starlix







Novartis Europharm Limited




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






EU/1/01/174


29.4.2022




25.4.2022


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


26.4.2022




25.4.2022


Trumenba







Pfizer Europe MA EEIG




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






EU/1/17/1187


26.4.2022




25.4.2022


Vazkepa







Amarin Pharmaceuticals Ireland Limited




88 Harcourt Street, Dublin 2, D02DK18, Ireland






EU/1/20/1524


26.4.2022




25.4.2022


Xofluza







Roche Registration GmbH




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






EU/1/20/1500


26.4.2022




28.4.2022


Gardasil 9







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1007


29.4.2022




29.4.2022


Azacitidine Accord







Accord Healthcare S.L.U.




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






EU/1/19/1413


2.5.2022




29.4.2022


CABOMETYX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/16/1136


2.5.2022




29.4.2022


Ecansya







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/12/763


9.5.2022




29.4.2022


Gardasil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/357


3.5.2022




29.4.2022


Gardasil 9







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1007


2.5.2022




29.4.2022


HyQvia







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/13/840


2.5.2022




29.4.2022


Imraldi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1216


4.5.2022




29.4.2022


Ixiaro







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/08/501


2.5.2022




29.4.2022


Jakavi







Novartis Europharm Limited




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






EU/1/12/773


3.5.2022




29.4.2022


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/12/782


5.5.2022




29.4.2022


Mekinist







Novartis Europharm Limited




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






EU/1/14/931


3.5.2022




29.4.2022


Nucala







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/15/1043


2.5.2022




29.4.2022


Ondexxya







Alexion Europe S.A.S.




103 Rue Anatole France, 92300 Levallois Perret, France






EU/1/18/1345


4.5.2022




29.4.2022


Poteligeo







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/18/1335


3.5.2022




29.4.2022


Seebri Breezhaler







Novartis Europharm Limited




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






EU/1/12/788


3.5.2022




29.4.2022


Spherox







CO.DON AG




Warthestraße 21, 14513 Teltow, Deutschland






EU/1/17/1181


2.5.2022




29.4.2022


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Del Principe De Vergara 132 Plt 12, 28002 Madrid, España






EU/1/20/1507


29.4.2022




29.4.2022


Tovanor Breezhaler







Novartis Europharm Limited




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






EU/1/12/790


3.5.2022




29.4.2022


Trevicta







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/971


2.5.2022




29.4.2022


Vosevi







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/17/1223


3.5.2022




29.4.2022


Xevudy







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


29.4.2022




—   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




13.4.2022


Pramipexole Accord







Accord Healthcare S.L.U.




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






EU/1/11/728


19.4.2022




25.4.2022


Docetaxel Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/07/384


26.4.2022




29.4.2022


Starlix







Novartis Europharm Limited




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






EU/1/01/174


3.5.2022




—   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




19.4.2022


Chanaxin


tulathromycin







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/22/283


Solution for injection


Pending


21.4.2022




19.4.2022


RenuTend


tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/22/282


Suspension for injection


QM09AX90


22.4.2022




—   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




4.4.2022


LETIFEND







LETI Pharma, S.L.U.




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






EU/2/16/195


6.4.2022




6.4.2022


CYTOPOINT







Zoetis Belgium S.A.




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






EU/2/17/205


11.4.2022




6.4.2022


RESPIPORC FLUpan H1N1







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/209


7.4.2022




13.4.2022


Ingelvac CircoFLEX







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/07/079


20.4.2022




19.4.2022


SevoFlo







Zoetis Belgium S.A.




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






EU/2/02/035


21.4.2022




26.4.2022


Credelio







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/206


28.4.2022




26.4.2022


CYTOPOINT







Zoetis Belgium S.A.




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






EU/2/17/205


3.5.2022




26.4.2022


RESPIPORC FLUpan H1N1







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/209


2.5.2022




26.4.2022


Zulvac BTV







Zoetis Belgium S.A.




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






EU/2/17/207


27.4.2022




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.