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Document 52026XC00402

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Nollaig 2025 go dtí 31 Nollaig 2025 (Arna fhoilsiú de bhun Airteagal 13 nó Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle)

PUB/2026/40

IO C, C/2026/402, 30.1.2026, ELI: http://data.europa.eu/eli/C/2026/402/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

ELI: http://data.europa.eu/eli/C/2026/402/oj

European flag

Iris Oifigiúil
an Aontais Eorpaigh

GA

Sraith C

C/2026/402

30.1.2026

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ó 1 Nollaig 2025 go dtí 31 Nollaig 2025

(Arna fhoilsiú de bhun Airteagal 13 nó Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle  (1) nó Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle  (2) )

(C/2026/402)

—   Údarú margaíochta a eisiúint (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

Dáta an chinnidh

Ainm an táirge íocshláinte

ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta)

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Foirm chógaisíochta

An Cód CAT (an Cód Ceimiceach Teiripeach Anatamaíoch)

Dáta an fhógra

22.12.2025

WAYRILZ

rilzabrutinib

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/25/1974

Piolla brataithe le scannán

Pending

23.12.2025

—   Údarú margaíochta a mhodhnú (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

4.12.2025

alli

Haleon Ireland Dungarvan Limited

Knockbrack,Dungarvan, Co. Waterford, Ireland

EU/1/07/401

5.12.2025

4.12.2025

AQUIPTA

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/23/1750

5.12.2025

4.12.2025

Beovu

Novartis Europharm Limited

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

EU/1/19/1417

5.12.2025

4.12.2025

Colobreathe

Essential Pharma Limited

Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara CBD 1070, Malta

EU/1/11/747

17.12.2025

4.12.2025

Gazyvaro

Roche Registration GmbH

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

EU/1/14/937

5.12.2025

4.12.2025

Ibandronic acid Accord

Accord Healthcare S.L.U.

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

EU/1/12/798

5.12.2025

4.12.2025

Lenalidomide Krka

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/20/1519

5.12.2025

4.12.2025

NULIBRY

TMC Pharma (EU) Limited

7a Durands Court, 45 Parnell Street, Waterford, Co. Waterford, X91 P381, Ireland

EU/1/22/1684

5.12.2025

4.12.2025

Rivastigmine Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/09/599

9.12.2025

4.12.2025

Ronapreve

Roche Registration GmbH

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

EU/1/21/1601

5.12.2025

4.12.2025

Tauvid

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/24/1799

8.12.2025

4.12.2025

Triumeq

ViiV Healthcare BV

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

EU/1/14/940

9.12.2025

4.12.2025

Xolair

Novartis Europharm Limited

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

EU/1/05/319

5.12.2025

5.12.2025

Aimovig

Novartis Europharm Limited

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

EU/1/18/1293

8.12.2025

5.12.2025

Lyvdelzi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/24/1898

8.12.2025

5.12.2025

Palforzia

STALLERGENES

6 rue Alexis de Tocqueville, 92160 Antony, France

EU/1/20/1495

15.12.2025

5.12.2025

Pregabalin Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1011

9.12.2025

5.12.2025

Soliris

Alexion Europe SAS

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

EU/1/07/393

8.12.2025

8.12.2025

AUGTYRO

Bristol Myers Squibb Pharma EEIG

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

EU/1/24/1883

11.12.2025

12.12.2025

ABSIMKY

Accord Healthcare S.L.U.

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

EU/1/24/1880

15.12.2025

12.12.2025

ALTUVOCT

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/24/1824

15.12.2025

12.12.2025

Arsenic Trioxide Accord

Accord Healthcare S.L.U.

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

EU/1/19/1398

15.12.2025

12.12.2025

Biktarvy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

17.12.2025

12.12.2025

Cystadane

Recordati Rare Diseases

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

EU/1/06/379

15.12.2025

12.12.2025

DuoTrav

Novartis Europharm Limited

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

EU/1/06/338

15.12.2025

12.12.2025

Enurev Breezhaler

Novartis Europharm Limited

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

EU/1/12/789

15.12.2025

12.12.2025

Exelon

Novartis Europharm Limited

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

EU/1/98/066

15.12.2025

12.12.2025

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

16.12.2025

12.12.2025

Onbrez Breezhaler

Novartis Europharm Limited

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

EU/1/09/593

15.12.2025

12.12.2025

Qaialdo

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/23/1731

16.12.2025

12.12.2025

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

15.12.2025

12.12.2025

Saphnelo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1623

15.12.2025

12.12.2025

Seffalair Spiromax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1533

18.12.2025

12.12.2025

Voydeya

Alexion Europe SAS

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

EU/1/24/1792

15.12.2025

15.12.2025

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

16.12.2025

15.12.2025

Minjuvi

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1570

16.12.2025

15.12.2025

Vedrop

Recordati Rare Diseases

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

EU/1/09/533

17.12.2025

15.12.2025

Yesafili

Biosimilar Collaborations Ireland Limited

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

EU/1/23/1751

16.12.2025

16.12.2025

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

17.12.2025

18.12.2025

Abiraterone Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/21/1553

5.1.2026

18.12.2025

Afqlir

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/24/1867

22.12.2025

18.12.2025

Alymsys

Mabxience Research SL

C/ Manuel Pombo Angulo 28, 28050 Madrid, España

EU/1/20/1509

20.12.2025

18.12.2025

Amsparity

Pfizer Europe MA EEIG

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

EU/1/19/1415

19.12.2025

18.12.2025

Avastin

Roche Registration GmbH

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

EU/1/04/300

19.12.2025

18.12.2025

Avzivi

FGK Representative Service GmbH

Heimeranstrasse 35, 80339 München, Deutschland

EU/1/24/1834

19.12.2025

18.12.2025

Aybintio

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

22.12.2025

18.12.2025

Farydak

pharmaand GmbH

Taborstrasse 1, 1020 Wien, Österreich

EU/1/15/1023

19.12.2025

18.12.2025

Inrebic

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1514

19.12.2025

18.12.2025

Lyxumia

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/12/811

19.12.2025

18.12.2025

M-M-RVAXPRO

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/337

19.12.2025

18.12.2025

Nexium Control

Haleon Ireland Dungarvan Limited

Knockbrack,Dungarvan, Co. Waterford, Ireland

EU/1/13/860

19.12.2025

18.12.2025

Oyavas

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/20/1510

19.12.2025

18.12.2025

Pedea

Recordati Rare Diseases

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

EU/1/04/284

19.12.2025

18.12.2025

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Industriestraße 18, 83607 Holzkirchen, Deutschland

EU/1/09/585

19.12.2025

18.12.2025

Shingrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

19.12.2025

18.12.2025

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

19.12.2025

18.12.2025

Vegzelma

Celltrion Healthcare Hungary Kft.

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

EU/1/22/1667

22.12.2025

18.12.2025

VEYVONDI

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/18/1298

19.12.2025

18.12.2025

Vyloy

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/24/1856

19.12.2025

18.12.2025

XALKORI

Pfizer Europe MA EEIG

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

EU/1/12/793

19.12.2025

18.12.2025

Xerava

PAION Pharma GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/18/1312

24.12.2025

18.12.2025

Zirabev

Pfizer Europe MA EEIG

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

EU/1/18/1344

19.12.2025

19.12.2025

Abevmy

Biosimilar Collaborations Ireland Limited

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

EU/1/20/1515

23.12.2025

19.12.2025

Abiraterone Accord

Accord Healthcare S.L.U.

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

EU/1/20/1512

22.12.2025

19.12.2025

Aldurazyme

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/03/253

22.12.2025

19.12.2025

Kevzara

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1196

22.12.2025

19.12.2025

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

22.12.2025

19.12.2025

Levetiracetam Accord

Accord Healthcare S.L.U.

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

EU/1/11/712

22.12.2025

19.12.2025

Mayzent

Novartis Europharm Limited

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

EU/1/19/1414

26.12.2025

19.12.2025

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

22.12.2025

19.12.2025

Mvasi

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

23.12.2025

19.12.2025

PHEBURANE

Eurocept International BV

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/822

23.12.2025

19.12.2025

Qdenga

Takeda Pharmaceuticals International AG

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

EU/1/22/1699

29.12.2025

19.12.2025

Seebri Breezhaler

Novartis Europharm Limited

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

EU/1/12/788

22.12.2025

19.12.2025

Teriparatide SUN

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp, Nederland

EU/1/22/1697

5.1.2026

19.12.2025

Topotecan Hospira

Pfizer Europe MA EEIG

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

EU/1/10/633

22.12.2025

19.12.2025

Voriconazole Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

22.12.2025

19.12.2025

Votrient

Novartis Europharm Limited

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

EU/1/10/628

22.12.2025

—   Údarú margaíochta a tharraingt siar (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle)

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

4.12.2025

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

10.12.2025

5.12.2025

Ronapreve

Roche Registration GmbH

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

EU/1/21/1601

8.12.2025

15.12.2025

ABSIMKY

Accord Healthcare S.L.U.

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

EU/1/24/1880

16.12.2025

18.12.2025

Lyxumia

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/12/811

19.12.2025

18.12.2025

Mimpara

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/04/292

7.1.2026

19.12.2025

Copiktra

Secura Bio Limited

32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland

EU/1/21/1542

5.1.2026

—   Údarú margaíochta a chur ar fionraí (Airteagal 20 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle)

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

9.12.2025

Oxbryta

Pfizer Europe MA EEIG

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

EU/1/21/1622

10.12.2025

—   Údarú margaíochta a eisiúint (Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle; Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

Dáta an chinnidh

Ainm an táirge íocshláinte

ANI (an tAinm Neamhdhílseánaigh Idirnáisiúnta)

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Foirm chógaisíochta

An Cód CAT (an Cód Ceimiceach Teiripeach Anatamaíoch)

Dáta an fhógra

4.12.2025

Vaxxinact H5

Avian influenza vaccine (subunit recombinant)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/25/356

Eibleacht le haghaidh insteallta

QI01AA23

8.12.2025

18.12.2025

ECOVAXXIN MS

Mycoplasma synoviae vaccine (live)

Eco Animal Health Europe Ltd

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

EU/2/25/357

Braonta súl, fuaidreán

QI01AE03

22.12.2025

—   Údarú margaíochta a mhodhnú (Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle; Airteagal 5 de Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

Dáta an chinnidh

Ainm an táirge íocshláinte

Sealbhóir an údaraithe margaíochta

Uimhir na hiontrála sa Chlár Comhphobail

Dáta an fhógra

18.12.2025

AdTab

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/22/288

22.12.2025

18.12.2025

Credelio Plus

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/21/271

22.12.2025

18.12.2025

Enteroporc Coli AC

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/262

19.12.2025

18.12.2025

FRONTPRO

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/240

19.12.2025

18.12.2025

Kriptazen

Virbac

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

EU/2/18/234

22.12.2025

18.12.2025

Librela

Zoetis Belgium

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

EU/2/20/261

19.12.2025

18.12.2025

Lotimax

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/24/311

22.12.2025

18.12.2025

Melosus

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/10/116

22.12.2025

18.12.2025

YURVAC RHD

Laboratorios Hipra, S.A.

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

EU/2/23/298

23.12.2025

18.12.2025

Zenalpha

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

19.12.2025

22.12.2025

Credelio

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/206

5.1.2026

22.12.2025

Vectormune FP ILT + AE

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/20/250

1.1.2026

Aon duine ar mian leis féachaint ar an tuarascáil mheasúnaithe phoiblí maidir leis na táirgí íocshláinte atá i gceist agus na cinntí a bhaineann léi, iarrtar orthu teagmháil a dhéanamh le:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1)   IO L 136, 30.4.2004, lch. 1, ELI: https://data.europa.eu/eli/reg/2004/726/oj.

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

ELI: http://data.europa.eu/eli/C/2026/402/oj

ISSN 1977-107X (electronic edition)

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