Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2023 to 31 August 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: 2023-09-29
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_2023350EN.01000101.xml










29.9.2023   


EN


Official Journal of the European Union


C 350/1







Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2023 to 31 August 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 350/01)

—   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




11.8.2023


AQUIPTA


atogepant







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/23/1750


Tablet


N02CD07


14.8.2023




21.8.2023


TALVEY


talquetamab







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/23/1748


Solution for injection


L01FX


22.8.2023




23.8.2023


Abrysvo


Respiratory syncytial virus vaccine (bivalent, recombinant)







Pfizer Europe MA EEIG




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






EU/1/23/1752


Powder and solvent for solution for injection


J07BX05


24.8.2023




—   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




3.8.2023


Eladynos







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/22/1706


4.8.2023




3.8.2023


Hulio







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1319


4.8.2023




3.8.2023


Palforzia







Aimmune Therapeutics Ireland Limited




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






EU/1/20/1495


8.8.2023




4.8.2023


Actelsar HCT







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/13/817


7.8.2023




4.8.2023


Clopidogrel Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/09/568


8.8.2023




4.8.2023


Hetlioz







Vanda Pharmaceuticals Netherlands B.V.




Basisweg 10, 1043 AP Amsterdam, Nederland






EU/1/15/1008


9.8.2023




4.8.2023


IMJUDO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1713


7.8.2023




4.8.2023


Lacosamide Accord







Accord Healthcare S.L.U.




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






EU/1/17/1230


7.8.2023




4.8.2023


Ogivri







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1341


8.8.2023




4.8.2023


Pemetrexed Pfizer







Pfizer Europe MA EEIG




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






EU/1/15/1057


7.8.2023




4.8.2023


Refixia







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1193


8.8.2023




4.8.2023


RotaTeq







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/348


8.8.2023




4.8.2023


Rukobia







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/20/1518


8.8.2023




4.8.2023


Tenofovir disoproxil Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1127


8.8.2023




4.8.2023


Topotecan Hospira







Pfizer Europe MA EEIG




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






EU/1/10/633


7.8.2023




4.8.2023


Viramune







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/055


8.8.2023




4.8.2023


Ziagen







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/99/112


7.8.2023




8.8.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


9.8.2023




9.8.2023


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


11.8.2023




9.8.2023


Namuscla







Lupin Europe GmbH




Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland






EU/1/18/1325


11.8.2023




9.8.2023


Pemetrexed Fresenius Kabi







Fresenius Kabi Deutschland GmbH




Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland






EU/1/16/1115


14.8.2023




9.8.2023


Roteas







Berlin-Chemie AG




Glienicker Weg 125, 12489 Berlin, Deutschland






EU/1/16/1152


10.8.2023




11.8.2023


Armisarte







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/15/1063


14.8.2023




11.8.2023


Dengvaxia







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/18/1338


30.8.2023




11.8.2023


Imnovid







Bristol Myers Squibb Pharma EEIG




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






EU/1/13/850


14.8.2023




11.8.2023


Invirase







Roche Registration GmbH




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






EU/1/96/026


14.8.2023




11.8.2023


Rivaroxaban Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/21/1588


14.8.2023




11.8.2023


Spikevax







MODERNA BIOTECH SPAIN, S.L.




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






EU/1/20/1507


21.8.2023




11.8.2023


TAKHZYRO







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/18/1340


18.8.2023




11.8.2023


Venclyxto







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/16/1138


14.8.2023




16.8.2023


Calquence







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1479


17.8.2023




16.8.2023


Ervebo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1392


17.8.2023




16.8.2023


Evrysdi







Roche Registration GmbH




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






EU/1/21/1531


17.8.2023




16.8.2023


EVUSHELD







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1651


17.8.2023




16.8.2023


Foclivia







Seqirus S.r.l.




Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia






EU/1/09/577


17.8.2023




16.8.2023


Mabthera







Roche Registration GmbH




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






EU/1/98/067


17.8.2023




16.8.2023


Ovaleap







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/13/871


17.8.2023




16.8.2023


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


17.8.2023




16.8.2023


Riximyo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1184


17.8.2023




16.8.2023


TECVAYLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1675


17.8.2023




16.8.2023


Truxima







Celltrion Healthcare Hungary Kft.




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






EU/1/16/1167


22.8.2023




16.8.2023


VITRAKVI







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/19/1385


17.8.2023




21.8.2023


Duloxetine Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1028


22.8.2023




21.8.2023


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


24.8.2023




21.8.2023


Signifor







Recordati Rare Diseases




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






EU/1/12/753


23.8.2023




23.8.2023


Blitzima







Celltrion Healthcare Hungary Kft.




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






EU/1/17/1205


25.8.2023




23.8.2023


Celdoxome pegylated liposomal







YES Pharmaceutical Development Services GmbH




Basler Strasse 7, 61352 Bad Homburg, Deutschland






EU/1/22/1666


6.9.2023




23.8.2023


Cholib







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/13/866


24.8.2023




23.8.2023


Efmody







Diurnal Europe B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/21/1549


29.8.2023




23.8.2023


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


28.8.2023




23.8.2023


Mounjaro







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/22/1685


25.8.2023




23.8.2023


Neuraceq







Life Radiopharma Berlin GmbH




Max-Planck-Straße 4, 12489 Berlin, Deutschland






EU/1/13/906


24.8.2023




23.8.2023


PecFent







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/10/644


4.9.2023




23.8.2023


Rixathon







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1185


24.8.2023




23.8.2023


Ruxience







Pfizer Europe MA EEIG




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






EU/1/20/1431


24.8.2023




23.8.2023


Symkevi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/18/1306


24.8.2023




23.8.2023


Tadalafil Lilly







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/17/1177


25.8.2023




23.8.2023


Vargatef







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/954


28.8.2023




23.8.2023


ZOLSKETIL pegylated liposomal







Accord Healthcare S.L.U.




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






EU/1/22/1629


24.8.2023




25.8.2023


Caelyx pegylated liposomal







Baxter Holding B.V.




Kobaltweg 49, 3542 CE Utrecht, Nederland






EU/1/96/011


29.8.2023




25.8.2023


Cialis







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/02/237


28.8.2023




25.8.2023


Erleada







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/18/1342


28.8.2023




25.8.2023


Eurartesim







Alfasigma S.p.A.




Via Ragazzi del '99, n.5, 40133 Bologna, Italia






EU/1/11/716


28.8.2023




25.8.2023


Fintepla







UCB Pharma S.A.




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






EU/1/20/1491


29.8.2023




25.8.2023


Reyataz







Bristol-Myers Squibb Pharma EEIG




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






EU/1/03/267


1.9.2023




25.8.2023


Semglee







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1270


28.8.2023




29.8.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


30.8.2023




29.8.2023


Spikevax







MODERNA BIOTECH SPAIN, S.L.




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






EU/1/20/1507


30.8.2023




30.8.2023


Abevmy







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/20/1515


4.9.2023




30.8.2023


Glyxambi







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/16/1146


1.9.2023




30.8.2023


Hulio







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1319


4.9.2023




30.8.2023


Kirsty







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/20/1506


4.9.2023




30.8.2023


Myclausen







Passauer Pharma GmbH




Eiderstedter Weg 3, 14129 Berlin, Deutschland






EU/1/10/647


4.9.2023




30.8.2023


Nepexto







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/20/1436


4.9.2023




30.8.2023


Ogivri







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/18/1341


4.9.2023




30.8.2023


Renvela







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/09/521


31.8.2023




30.8.2023


Synjardy







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/15/1003


1.9.2023




31.8.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


1.9.2023




—   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




16.8.2023


Invirase







Roche Registration GmbH




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






EU/1/96/026


17.8.2023




30.8.2023


Imatinib Koanaa







Koanaa Healthcare GmbH




Fehrgasse 7, 2401 Fischamend, Österreich






EU/1/21/1568


4.9.2023




30.8.2023


JETREA







Inceptua AB




Gustavslundsv. 143, 16751 Bromma, Sverige






EU/1/13/819


31.8.2023




—   Suspension of a marketing authorisation (Article 20 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




3.8.2023


Adakveo







Novartis Europharm Limited




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






EU/1/20/1476


4.8.2023




—   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




4.8.2023


CYTOPOINT







Zoetis Belgium




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






EU/2/17/205


7.8.2023




4.8.2023


MHYOSPHERE PCV ID







Laboratorios Hipra, S.A.




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






EU/2/20/259


21.8.2023




4.8.2023


NASYM







Laboratorios Hipra, S.A.




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






EU/2/19/241


1.9.2023




8.8.2023


Easotic







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/08/085


10.8.2023




8.8.2023


Versican Plus DHPPi







Zoetis Belgium




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






EU/2/14/169


29.8.2023




8.8.2023


Versican Plus DHPPi/L4







Zoetis Belgium




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






EU/2/14/164


29.8.2023




11.8.2023


Felpreva







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/21/277


21.8.2023




11.8.2023


SevoFlo







Zoetis Belgium




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






EU/2/02/035


14.8.2023




24.8.2023


Apoquel







Zoetis Belgium




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






EU/2/13/154


25.8.2023




24.8.2023


Cimalgex







Vétoquinol SA




Magny-Vernois, 70200 Lure, France






EU/2/10/119


25.8.2023




24.8.2023


CircoMax Myco







Zoetis Belgium




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






EU/2/20/264


25.8.2023




24.8.2023


Dexdomitor







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/02/033


25.8.2023




24.8.2023


NexGard Combo







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/267


25.8.2023




24.8.2023


Panacur AquaSol







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/135


25.8.2023




24.8.2023


RenuTend







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/22/282


25.8.2023




24.8.2023


Ypozane







VIRBAC S.A.




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






EU/2/06/068


25.8.2023




24.8.2023


Zactran







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/08/082


25.8.2023




24.8.2023


Zuprevo







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/124


29.8.2023




25.8.2023


Bonqat







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/21/273


28.8.2023




25.8.2023


Palladia







Zoetis Belgium




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






EU/2/09/100


1.9.2023




30.8.2023


Porcilis PCV







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/08/091


31.8.2023




30.8.2023


Tessie







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/21/276


31.8.2023




—   Withdrawal 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)









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




24.8.2023


Nobivac Myxo-RHD







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/132


28.8.2023




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.