Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2026 to 28 February 2026 (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: 2026-03-31
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_202601816EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/1816


31.3.2026






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2026 to 28 February 2026
         


(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/2026/1816)







—



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




10.2.2026


Gotenfia


golimumab


STADA Arzneimittel AG
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland


EU/1/25/2009


Concentrate for solution for injection


L04AB06


12.2.2026




10.2.2026


Ranluspec


ranibizumab


Lupin Europe GmbH
Hanauer Landstraße 139-143, 60314 Frankfurt, Deutschland


EU/1/25/2012


Solution for injection
Solution for injection in a pre-filled syringe


S01LA04


17.2.2026




12.2.2026


Aumseqa


aumolertinib


SFL Pharmaceuticals Deutschland GmbH
Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland


EU/1/25/2006


Film-coated tablet


L01EB11


13.2.2026




12.2.2026


EXDENSUR


Depemokimab


GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland


EU/1/25/2007


Solution for injection


R03DX12


16.2.2026




12.2.2026


mNEXSPIKE


COVID-19 mRNA vaccine


MODERNA BIOTECH SPAIN, S.L.
C/ Julián Camarillo no 31, 28037 Madrid, España


EU/1/25/2010


dispersion for injection


J07BN01


13.2.2026




12.2.2026


MYQORZO


aficamten


Cytokinetics (Ireland) Limited
45 Mespil Rd. Dublin D04 W2F1 Ireland


EU/1/25/2014


Film-coated tablet


Pending


13.2.2026




16.2.2026


ANKTIVA


nogapendekin alfa inbakicept


ImmunityBio Ireland Limited
6th Floor, 2 Grand Canal Square, Dublin 2, D02 A342, Ireland


EU/1/25/2002


Concentrate for intravesical suspension


L03AC03


17.2.2026




20.2.2026


Deltyba


delamanid


Otsuka Novel Products GmbH
Erika-Mann-Straße 21, 80636 München, Deutschland


EU/1/13/875


Film-coated tablet


J04AK06


23.2.2026














—



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




4.2.2026


Actelsar HCT


Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Íceland


EU/1/13/817


6.2.2026




4.2.2026


Lytenava


Outlook Therapeutics NL B.V.
Strawinskylaan 569, 1077XX Amsterdam, Nederland


EU/1/24/1798


5.2.2026




4.2.2026


Nucala


GlaxoSmithKline Trading Services Limited
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland


EU/1/15/1043


5.2.2026




10.2.2026


Carbaglu


Recordati Rare Diseases
Tour Hekla, 52 Avenue Du General De Gaulle, 92800 Puteaux, France


EU/1/02/246


16.2.2026




10.2.2026


Casgevy


Vertex Pharmaceuticals (Ireland) Limited
Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland


EU/1/23/1787


12.2.2026




10.2.2026


Emadine


Immedica Pharma AB
SE-113 63, Stockholm, Sverige


EU/1/98/095


11.2.2026




10.2.2026


Enspryng


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/21/1559


11.2.2026




10.2.2026


JEMPERLI


GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland


EU/1/21/1538


13.2.2026




10.2.2026


Kengrexal


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/15/994


17.2.2026




10.2.2026


Myalepta


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/18/1276


11.2.2026




10.2.2026


Relistor


Bausch Health Ireland Limited
3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland


EU/1/08/463


13.2.2026




10.2.2026


Retsevmo


Eli Lilly Nederland B.V.
Orteliuslaan 1000, 3528 BD, Nederland


EU/1/20/1527


11.2.2026




10.2.2026


Uplizna


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/21/1602


11.2.2026




10.2.2026


Vfend


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België


EU/1/02/212


11.2.2026




12.2.2026


Akynzeo


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland


EU/1/15/1001


13.2.2026




12.2.2026


Aptivus


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/05/315


15.2.2026




12.2.2026


Bronchitol


Pharmaxis Europe Limited
108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland


EU/1/12/760


16.2.2026




12.2.2026


Emblaveo


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België


EU/1/24/1808


13.2.2026




12.2.2026


EndolucinBeta


ITM Medical Isotopes GmbH
Lichtenbergstraße 1, 85748 Garching/München, Deutschland


EU/1/16/1105


13.2.2026




12.2.2026


Klisyri


Almirall, S.A.
Ronda General Mitre, 151, 08022 Barcelona, España


EU/1/21/1558


13.2.2026




12.2.2026


Mvabea


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/20/1445


13.2.2026




12.2.2026


Orladeyo


Biocryst Ireland Limited
Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland


EU/1/21/1544


13.2.2026




12.2.2026


Pemazyre


Incyte Biosciences Distribution B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/21/1535


13.2.2026




12.2.2026


Ponvory


LABORATOIRES JUVISE PHARMACEUTICALS
149 Boulevard Bataille de Stalingrad, 69100 Villeurbanne, France


EU/1/21/1550


18.2.2026




12.2.2026


Skyrizi


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/19/1361


13.2.2026




12.2.2026


Veoza


Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland


EU/1/23/1771


17.2.2026




12.2.2026


Yondelis


Pharma Mar S.A.
Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España


EU/1/07/417


18.2.2026




12.2.2026


Zynlonta


Swedish Orphan Biovitrum AB (publ)
112 76 Stockholm, Sverige


EU/1/22/1695


13.2.2026




16.2.2026


Abraxane


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/07/428


17.2.2026




16.2.2026


SIMBRINZA


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/933


17.2.2026




16.2.2026


Strensiq


Alexion Europe SAS
103-105 rue Anatole France, 92300 Levallois-Perret, France


EU/1/15/1015


18.2.2026




16.2.2026


Wegovy


Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark


EU/1/21/1608


17.2.2026




16.2.2026


Zabdeno


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/20/1444


17.2.2026




18.2.2026


Busulfan Fresenius Kabi


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


EU/1/14/951


19.2.2026




18.2.2026


Dimethyl fumarate Neuraxpharm


Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España


EU/1/24/1810


23.2.2026




18.2.2026


Irbesartan Zentiva


Zentiva k.s.
U kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/06/376


23.2.2026




18.2.2026


Jylamvo


Oresund Pharma ApS
Orient Plads 1, 2150 Nordhavn, Danmark


EU/1/17/1172


20.2.2026




18.2.2026


Kinzalmono


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/98/091


19.2.2026




18.2.2026


Livmarli


Mirum Pharmaceuticals International B.V.
Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland


EU/1/22/1704


19.2.2026




18.2.2026


Micardis


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/98/090


19.2.2026




18.2.2026


Natpar


Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland


EU/1/15/1078


20.2.2026




18.2.2026


Pritor


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/98/089


19.2.2026




18.2.2026


Xevudy


GlaxoSmithKline Trading Services Limited
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland


EU/1/21/1562


19.2.2026




20.2.2026


Rybrevant


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/21/1594


23.2.2026




23.2.2026


Afinitor


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/538


24.2.2026




23.2.2026


Atazanavir Krka


KRKA d d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/19/1353


25.2.2026




23.2.2026


Balversa


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/24/1841


24.2.2026




23.2.2026


Copalia


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/372


24.2.2026




23.2.2026


Dafiro


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/371


24.2.2026




23.2.2026


Evkeeza


Ultragenyx Germany GmbH
Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland


EU/1/21/1551


24.2.2026




23.2.2026


Kadcyla


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/13/885


24.2.2026




23.2.2026


Obgemsa


PIERRE FABRE MEDICAMENT
Les Cauquillous, 81500 Lavaur, France


EU/1/24/1822


2.3.2026




23.2.2026


Ravicti


Immedica Pharma AB
SE-113 63, Stockholm, Sverige


EU/1/15/1062


2.3.2026




23.2.2026


Sitagliptin Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/22/1633


25.2.2026




23.2.2026


Tabrecta


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/22/1650


24.2.2026




23.2.2026


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


24.2.2026




23.2.2026


Telmisartan Actavis


Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Íceland


EU/1/10/639


25.2.2026




23.2.2026


Trazimera


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België


EU/1/18/1295


24.2.2026




23.2.2026


Vectibix


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/07/423


24.2.2026




23.2.2026


Viagra


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


EU/1/98/077


10.3.2026




23.2.2026


Vokanamet


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/14/918


24.2.2026




23.2.2026


Wilzin


Recordati Rare Diseases
Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France


EU/1/04/286


24.2.2026




25.2.2026


Bimzelx


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/21/1575


2.3.2026




25.2.2026


Bortezomib Fresenius Kabi


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


EU/1/19/1397


26.2.2026




25.2.2026


Exforge HCT


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/569


26.2.2026




25.2.2026


Neoatricon


BrePco Biopharma Ltd.
Suite One, The Avenue, Beacon Court, Sandyford, Dublin D18HX31, Ireland


EU/1/24/1804


27.2.2026




25.2.2026


Nexium Control


Haleon Ireland Dungarvan Limited
Knockbrack,Dungarvan, Co. Waterford, Ireland


EU/1/13/860


3.3.2026




25.2.2026


Nimenrix


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België


EU/1/12/767


26.2.2026




25.2.2026


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


26.2.2026




25.2.2026


Oslif Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/586


26.2.2026




25.2.2026


Strimvelis


Fondazione Telethon ETS
Via Varese 16/B, 00185 Roma, Italia


EU/1/16/1097


26.2.2026




25.2.2026


Suliqua


Sanofi Winthrop Industrie
82 avenue Raspail, 94250 Gentilly, France


EU/1/16/1157


26.2.2026




25.2.2026


Ultibro Breezhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/13/862


26.2.2026




26.2.2026


Copalia HCT


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/575


27.2.2026




26.2.2026


Dafiro HCT


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/09/574


27.2.2026




26.2.2026


Exforge


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/370


27.2.2026




26.2.2026


Incellipan


Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland


EU/1/24/1807


2.3.2026




26.2.2026


Pepaxti


Oncopeptides AB (publ)
Luntmakargatan 46, 111 37 Stockholm, Sverige


EU/1/22/1669


3.3.2026




26.2.2026


Thiotepa Riemser


Esteve Pharmaceuticals GmbH
Hohenzollerndamm 150-151, 14199 Berlin, Deutschland


EU/1/21/1536


27.2.2026














—



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




18.2.2026


Xevudy


GlaxoSmithKline Trading Services Limited
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland


EU/1/21/1562


20.2.2026




23.2.2026


Atazanavir Krka


KRKA d d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/19/1353


2.3.2026




23.2.2026


Fluad Tetra


Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland


EU/1/20/1433


24.2.2026




23.2.2026


Flucelvax Tetra


Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland


EU/1/18/1326


25.2.2026




23.2.2026


Zegalogue


Zealand Pharma A/S
Sydmarken 11, 2860 Soeborg, Danmark


EU/1/24/1829


24.2.2026














—



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




25.2.2026


Lotilaner/Milbemycin Elanco


lotilaner / milbemycin oxime


Elanco GmbH
Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Deutschland


EU/2/26/361


Chewable tablet


QP54AB51


27.2.2026














—



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




16.2.2026


Mirataz


Dechra Regulatory B.V.
Handelsweg 25, 5531 AE Bladel, Nederland


EU/2/19/247


23.2.2026








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, ELI: https://data.europa.eu/eli/reg/2004/726/oj.

(2)  
            OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.


ELI: http://data.europa.eu/eli/C/2026/1816/oj
ISSN 1977-091X (electronic edition)