Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2023 to 30 November 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: 2023-12-29
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_202301562EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2023/1562


29.12.2023






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2023 to 30 November 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))
(C/2023/1562)

—   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




3.11.2023


Ninlaro


ixazomib







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


Capsule, hard


L01XG03


6.11.2023




6.11.2023


VANFLYTA


quizartinib







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/23/1768


Film-coated tablet


L01EX11


7.11.2023




15.11.2023


AQUMELDI


enalapril maleate







Proveca Pharma Limited




2 Dublin Landings, North Wall Quay, Dublin 1, Ireland






EU/1/23/1717


Orodispersible tablet


C09AA02


16.11.2023




15.11.2023


Catiolanze


latanoprost







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/23/1763


Eye drops, emulsion


S01EE01


16.11.2023




15.11.2023


Dovprela


pretomanid







Mylan IRE Healthcare Limited




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






EU/1/20/1437


Tablet


J04AK08


16.11.2023




15.11.2023


Finlee


dabrafenib







Novartis Europharm Limited




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






EU/1/23/1767


Dispersible tablet


L01EC02


16.11.2023




15.11.2023


Herwenda


trastuzumab







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/23/1762


Powder for concentrate for solution for infusion


L01FD01


16.11.2023




16.11.2023


Ebglyss


lebrikizumab







Almirall S.A.




Ronda General Mitre 151, 08022 Barcelona, España






EU/1/23/1765


Solution for injection


Pending


17.11.2023




17.11.2023


Yorvipath


palopegteriparatide







Ascendis Pharma Bone Diseases A/S




Tuborg Boulevard 12, DK-2900 Hellerup, Danmark






EU/1/23/1766


Solution for injection


H05AA05


20.11.2023




—   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




3.11.2023


Copalia HCT







Novartis Europharm Limited




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






EU/1/09/575


6.11.2023




3.11.2023


Exforge HCT







Novartis Europharm Limited




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






EU/1/09/569


6.11.2023




3.11.2023


Jorveza







Dr Falk Pharma GmbH




Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland






EU/1/17/1254


6.11.2023




3.11.2023


Lutetium (177Lu) chloride Billev







Billev Pharma ApS




Slotsmarken 10, 2970 Hørsholm, Danmark






EU/1/22/1680


6.11.2023




3.11.2023


NeoRecormon







Roche Registration GmbH




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






EU/1/97/031


6.11.2023




3.11.2023


Rizmoic







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/18/1291


6.11.2023




3.11.2023


Tremelimumab AstraZeneca







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1712


6.11.2023




6.11.2023


AJOVY







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/19/1358


10.11.2023




6.11.2023


Copalia







Novartis Europharm Limited




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






EU/1/06/372


8.11.2023




6.11.2023


Dafiro







Novartis Europharm Limited




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






EU/1/06/371


8.11.2023




6.11.2023


IDELVION







CSL Behring GmbH




Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland






EU/1/16/1095


9.11.2023




6.11.2023


Silodosin Recordati







Recordati Ireland Ltd




Raheens East, Ringaskiddy Co. Cork P43 KD30, Ireland






EU/1/18/1343


8.11.2023




6.11.2023


Xolair







Novartis Europharm Limited




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






EU/1/05/319


8.11.2023




6.11.2023


Zirabev







Pfizer Europe MA EEIG




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






EU/1/18/1344


7.11.2023




15.11.2023


Brukinsa







BeiGene Ireland Limited




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






EU/1/21/1576


16.11.2023




15.11.2023


Carmustine medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/18/1278


16.11.2023




15.11.2023


Dafiro HCT







Novartis Europharm Limited




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






EU/1/09/574


16.11.2023




15.11.2023


Daxas







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/10/636


16.11.2023




15.11.2023


Evra







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/02/223


20.11.2023




15.11.2023


Exforge







Novartis Europharm Limited




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






EU/1/06/370


16.11.2023




15.11.2023


Fuzeon







Roche Registration GmbH




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






EU/1/03/252


16.11.2023




15.11.2023


Harvoni







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/14/958


16.11.2023




15.11.2023


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


16.11.2023




15.11.2023


Kivexa







ViiV Healthcare BV




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






EU/1/04/298


16.11.2023




15.11.2023


Miglustat Dipharma







Dipharma Arzneimittel GmbH




Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland






EU/1/18/1346


16.11.2023




15.11.2023


Ocaliva







ADVANZ PHARMA Limited




Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland






EU/1/16/1139


22.11.2023




15.11.2023


Praluent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/15/1031


16.11.2023




15.11.2023


PREVYMIS







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/17/1245


16.11.2023




15.11.2023


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/06/380


16.11.2023




15.11.2023


Prometax







Novartis Europharm Limited




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






EU/1/98/092


16.11.2023




15.11.2023


Rezolsta







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/967


16.11.2023




15.11.2023


Rilutek







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/96/010


16.11.2023




15.11.2023


Rubraca







pharmaand GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/17/1250


20.11.2023




15.11.2023


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/494


16.11.2023




15.11.2023


Sustiva







Bristol-Myers Squibb Pharma EEIG




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






EU/1/99/110


20.11.2023




15.11.2023


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


17.11.2023




15.11.2023


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


16.11.2023




15.11.2023


Triumeq







ViiV Healthcare BV




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






EU/1/14/940


16.11.2023




15.11.2023


Trizivir







ViiV Healthcare BV




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






EU/1/00/156


16.11.2023




15.11.2023


Vafseo







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37, 58638 Iserlohn, Deutschland






EU/1/23/1725


30.11.2023




15.11.2023


VEYVONDI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/18/1298


16.11.2023




15.11.2023


Vyvgart







argenx BV




Industriepark-Zwijnaarde 7, 9052 Gent, België






EU/1/22/1674


16.11.2023




15.11.2023


Xaluprine







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland






EU/1/11/727


16.11.2023




15.11.2023


Yuflyma







Celltrion Healthcare Hungary Kft.




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






EU/1/20/1513


20.11.2023




15.11.2023


Zynlonta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/22/1695


17.11.2023




20.11.2023


Descovy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1099


22.11.2023




20.11.2023


Intelence







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/468


21.11.2023




20.11.2023


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/12/782


21.11.2023




20.11.2023


Lumykras







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1603


21.11.2023




20.11.2023


Orgovyx







Accord Healthcare S.L.U.




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






EU/1/22/1642


21.11.2023




20.11.2023


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


21.11.2023




20.11.2023


Pelmeg







Mundipharma Corporation (Ireland) Limited




United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland.






EU/1/18/1328


21.11.2023




20.11.2023


Pirfenidone Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/22/1707


21.11.2023




20.11.2023


Roteas







Berlin-Chemie AG




Glienicker Weg 125, 12489 Berlin, Deutschland






EU/1/16/1152


22.11.2023




20.11.2023


Sirturo







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/901


21.11.2023




20.11.2023


Ziagen







ViiV Healthcare BV




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






EU/1/99/112


21.11.2023




22.11.2023


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/20/1468


23.11.2023




23.11.2023


Cufence







Univar Solutions B.V.




Schouwburgplein 30, Rotterdam, 3012 CL, Nederland






EU/1/19/1365


27.11.2023




23.11.2023


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


24.11.2023




23.11.2023


PHEBURANE







Eurocept International BV




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/13/822


24.11.2023




29.11.2023


Betaferon







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/95/003


30.11.2023




29.11.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


30.11.2023




29.11.2023


Eviplera







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/11/737


1.12.2023




29.11.2023


Extavia







Novartis Europharm Limited




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






EU/1/08/454


7.12.2023




29.11.2023


Lixiana







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/15/993


30.11.2023




29.11.2023


NYXTHRACIS







SFL Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/20/1485


30.11.2023




29.11.2023


Posaconazole Accord







Accord Healthcare S.L.U.




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






EU/1/19/1379


30.11.2023




29.11.2023


Resolor







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/09/581


1.12.2023




29.11.2023


Tabrecta







Novartis Europharm Limited




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






EU/1/22/1650


4.12.2023




29.11.2023


Taxotere







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/95/002


1.12.2023




29.11.2023


Xermelo







SERB SAS




40 Avenue George V, 75008 Paris, France






EU/1/17/1224


4.12.2023




29.11.2023


Yesafili







Biosimilar Collaborations Ireland Limited




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






EU/1/23/1751


30.11.2023




—   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




6.11.2023


Tremelimumab AstraZeneca







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1712


7.11.2023




—   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




20.11.2023


Nobivac LoVo L4


Canine leptospira vaccine







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/23/304


Suspension for injection


QI07AB01


21.11.2023




20.11.2023


Senvelgo


velagliflozin







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/23/305


Oral solution


QA10BK90


22.11.2023




23.11.2023


Bovilis Cryptium



Cryptosporidium parvum Gp40







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/23/303


Emulsion for injection


QI02AO02


24.11.2023




—   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




3.11.2023


Felisecto Plus







Zoetis Belgium




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






EU/2/19/238


7.11.2023




20.11.2023


Tulinovet







V.M.D.n.v.




Hoge Mauw 900, 2370 Arendonk, Belgïe






EU/2/20/257


21.11.2023




23.11.2023


CircoMax







Zoetis Belgium




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






EU/2/21/281


24.11.2023




23.11.2023


FORTEKOR PLUS







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/15/185


24.11.2023




23.11.2023


Porcilis PCV ID







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/187


24.11.2023




23.11.2023


Suiseng Diff/A







Laboratorios Hipra, S.A.




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






EU/2/21/278


27.11.2023




23.11.2023


Suvaxyn CSF Marker







Zoetis Belgium




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






EU/2/14/179


27.11.2023




30.11.2023


Exzolt







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/212


4.12.2023




30.11.2023


Isemid







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/18/232


1.12.2023




30.11.2023


Kriptazen







Virbac




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






EU/2/18/234


1.12.2023




30.11.2023


Veraflox







Elanco Animal Health GmbH




Alfred-Nobel-Str. 50, 40789 Monheim, Deutschland






EU/2/10/107


1.12.2023




—   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




20.11.2023


Activyl







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/10/118


23.11.2023




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.


ELI: http://data.europa.eu/eli/C/2023/1562/oj
ISSN 1977-091X (electronic edition)