|
Date de la décision
|
Nom du médicament
|
Titulaire d'une autorisation de mise sur le marché
|
Numéro de l'entrée dans le registre communautaire
|
Date de notification
|
|
3.9.2026
|
Abecma
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/21/1539
|
4.9.2026
|
|
3.9.2026
|
JERAYGO
|
|
Idorsia Pharmaceuticals Deutschland GmbH
|
|
Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland
|
|
EU/1/24/1818
|
8.9.2026
|
|
3.9.2026
|
Miglustat Gen.Orph
|
|
Gen.Orph
|
|
185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France
|
|
EU/1/17/1232
|
4.9.2026
|
|
3.9.2026
|
Symtuza
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/17/1225
|
4.9.2026
|
|
3.9.2026
|
Zimbus Breezhaler
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/20/1440
|
4.9.2026
|
|
11.9.2026
|
Amlodipine/Valsartan Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1092
|
14.9.2026
|
|
11.9.2026
|
BEYONTTRA
|
|
Bayer AG
|
|
51368 Leverkusen, Deutschland
|
|
EU/1/24/1906
|
14.9.2026
|
|
11.9.2026
|
Brintellix
|
|
H. Lundbeck A/S
|
|
Ottiliavej 9, 2500 Valby, Danmark
|
|
EU/1/13/891
|
14.9.2026
|
|
11.9.2026
|
Lixiana
|
|
Daiichi Sankyo Europe GmbH
|
|
Zielstattstraße 48, 81379 München, Deutschland
|
|
EU/1/15/993
|
15.9.2026
|
|
11.9.2026
|
Prolia
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/10/618
|
15.9.2026
|
|
11.9.2026
|
Riluzole Zentiva
|
|
Zentiva k.s.
|
|
U kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/12/768
|
14.9.2026
|
|
11.9.2026
|
Rivaroxaban Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1488
|
14.9.2026
|
|
11.9.2026
|
Wezenla
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
|
|
EU/1/24/1823
|
10.8.2026
|
|
11.9.2026
|
Wezenla
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
|
|
EU/1/24/1823
|
14.9.2026
|
|
11.9.2026
|
Zokinvy
|
|
Integral Pharma Solutions EU Limited
|
|
1 Windmill Lane, Dublin 2, Co. Dublin, D02 F206, Ireland
|
|
EU/1/22/1660
|
14.9.2026
|
|
11.9.2026
|
Zolgensma
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/20/1443
|
18.9.2026
|
|
11.9.2026
|
Zonegran
|
|
Amdipharm Limited
|
|
Unit 17, Northwood House, Northwood Crescent, Northwood, Dublin 9, D09 V504, Ireland
|
|
EU/1/04/307
|
22.9.2026
|
|
14.9.2026
|
Firazyr
|
|
Takeda Pharmaceuticals International AG Ireland Branch
|
|
Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
|
|
EU/1/08/461
|
15.9.2026
|
|
14.9.2026
|
Herwenda
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/23/1762
|
15.9.2026
|
|
14.9.2026
|
IMBRUVICA
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/14/945
|
15.9.2026
|
|
14.9.2026
|
Lazcluze
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/24/1886
|
15.9.2026
|
|
14.9.2026
|
Miglustat Dipharma
|
|
Dipharma Arzneimittel GmbH
|
|
Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland
|
|
EU/1/18/1346
|
18.9.2026
|
|
14.9.2026
|
Pergoveris
|
|
Merck Europe B.V.
|
|
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
|
EU/1/07/396
|
16.9.2026
|
|
14.9.2026
|
Skytrofa
|
|
Ascendis Pharma Endocrinology Division A/S
|
|
Tuborg Boulevard 12, 2900 Hellerup, Danmark
|
|
EU/1/21/1607
|
16.9.2026
|
|
14.9.2026
|
Steqeyma
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/24/1844
|
24.8.2026
|
|
14.9.2026
|
Steqeyma
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/24/1844
|
17.9.2026
|
|
14.9.2026
|
Sugammadex Adroiq
|
|
Extrovis EU Kft.
|
|
Raktarvarosi Ut 9, Torokbalint, 2045, Magyarország
|
|
EU/1/23/1733
|
16.9.2026
|
|
14.9.2026
|
Tasmar
|
|
Viatris Healthcare Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/97/044
|
15.9.2026
|
|
14.9.2026
|
Tepmetko
|
|
Merck Europe B.V.
|
|
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
|
EU/1/21/1596
|
16.9.2026
|
|
14.9.2026
|
Xaluprine
|
|
Lipomed GmbH
|
|
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland
|
|
EU/1/11/727
|
15.9.2026
|
|
14.9.2026
|
Zyprexa
|
|
CHEPLAPHARM Registration GmbH
|
|
Weiler Straße 5e, 79540 Lörrach, Deutschland
|
|
EU/1/96/022
|
17.9.2026
|
|
17.9.2026
|
Afqlir
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/24/1867
|
2.10.2026
|
|
18.9.2026
|
Afiveg
|
|
STADA Arzneimittel AG
|
|
Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland
|
|
EU/1/25/1965
|
24.9.2026
|
|
18.9.2026
|
Ahzantive
|
|
Formycon AG
|
|
82152 Martinsried/Planegg, Deutschland
|
|
EU/1/24/1888
|
21.9.2026
|
|
18.9.2026
|
BLINCYTO
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/15/1047
|
21.9.2026
|
|
18.9.2026
|
Bysumlog
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/26/2030
|
21.9.2026
|
|
18.9.2026
|
Ebvallo
|
|
Pierre Fabre Medicament
|
|
Les Cauquillous, 81500 Lavaur, France
|
|
EU/1/22/1700
|
22.9.2026
|
|
18.9.2026
|
Eiyzey
|
|
Zakłady Farmaceutyczne POLPHARMA S.A.
|
|
ul. Pelplińska 19, 83-200 Starogard Gdański, Polska
|
|
EU/1/25/1963
|
21.9.2026
|
|
18.9.2026
|
Enerzair Breezhaler
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/20/1438
|
22.9.2026
|
|
18.9.2026
|
Eydenzelt
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/24/1895
|
29.9.2026
|
|
18.9.2026
|
Eylea
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/12/797
|
21.9.2026
|
|
18.9.2026
|
Eyluxvi
|
|
Biolitec Pharma Limited Zweigniederlassung Jena
|
|
Otto-Schott-Str. 15, 07745 Jena, Deutschland
|
|
EU/1/25/1972
|
29.9.2026
|
|
18.9.2026
|
FABHALTA
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/24/1802
|
22.9.2026
|
|
18.9.2026
|
Glyxambi
|
|
Boehringer Ingelheim International GmbH
|
|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
|
EU/1/16/1146
|
22.9.2026
|
|
18.9.2026
|
Hirobriz Breezhaler
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/09/594
|
22.9.2026
|
|
18.9.2026
|
Hyftor
|
|
Plusultra pharma GmbH
|
|
Fritz-Vomfelde-Str. 36, 40547 Düsseldorf, Deutschland
|
|
EU/1/23/1723
|
21.9.2026
|
|
18.9.2026
|
Idacio
|
|
Fresenius Kabi Deutschland GmbH
|
|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
|
EU/1/19/1356
|
23.9.2026
|
|
18.9.2026
|
Jentadueto
|
|
Boehringer Ingelheim International GmbH
|
|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
|
EU/1/12/780
|
22.9.2026
|
|
18.9.2026
|
Kaftrio
|
|
Vertex Pharmaceuticals (Ireland) Limited
|
|
Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland
|
|
EU/1/20/1468
|
21.9.2026
|
|
18.9.2026
|
Litfulo
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/23/1755
|
21.9.2026
|
|
18.9.2026
|
Lunsumio
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/22/1649
|
21.9.2026
|
|
18.9.2026
|
Mylotarg
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/18/1277
|
21.9.2026
|
|
18.9.2026
|
MYNZEPLI
|
|
Advanz Pharma Limited
|
|
Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland
|
|
EU/1/25/1964
|
21.9.2026
|
|
18.9.2026
|
NULIBRY
|
|
Integral Pharma Solutions EU Limited
|
|
1 Windmill Lane, Dublin 2, Co. Dublin, D02 F206, Ireland
|
|
EU/1/22/1684
|
21.9.2026
|
|
18.9.2026
|
Omnitrope
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/06/332
|
21.9.2026
|
|
18.9.2026
|
Opuviz
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/24/1865
|
22.9.2026
|
|
18.9.2026
|
Otulfi
|
|
Fresenius Kabi Deutschland GmbH
|
|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
|
EU/1/24/1863
|
23.9.2026
|
|
18.9.2026
|
PAVBLU
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, A96 F2A8, Ireland
|
|
EU/1/25/1909
|
21.9.2026
|
|
18.9.2026
|
Plavix
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/98/069
|
21.9.2026
|
|
18.9.2026
|
Replagal
|
|
Takeda Pharmaceuticals International AG Ireland Branch
|
|
Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
|
|
EU/1/01/189
|
21.9.2026
|
|
18.9.2026
|
Riltrava Aerosphere
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/21/1604
|
21.9.2026
|
|
18.9.2026
|
RINVOQ
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/19/1404
|
21.9.2026
|
|
18.9.2026
|
Rivaroxaban Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/21/1588
|
22.9.2026
|
|
18.9.2026
|
Roteas
|
|
Berlin-Chemie AG
|
|
Glienicker Weg 125, 12489 Berlin, Deutschland
|
|
EU/1/16/1152
|
21.9.2026
|
|
18.9.2026
|
Svariya
|
|
PGF Pharma International d.o.o.
|
|
Ulica Roberta Frangeša Mihanovića 9, 10110 Zagreb, Hrvatska
|
|
EU/1/25/1994
|
21.9.2026
|
|
18.9.2026
|
Tevimbra
|
|
BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/23/1758
|
22.9.2026
|
|
18.9.2026
|
Tolucombi
|
|
KRKA d d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/13/821
|
21.9.2026
|
|
18.9.2026
|
TRIXEO AEROSPHERE
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/20/1498
|
21.9.2026
|
|
18.9.2026
|
Vyepti
|
|
H. Lundbeck A/S
|
|
Ottiliavej 9, 2500 Valby, Danmark
|
|
EU/1/21/1599
|
22.9.2026
|
|
18.9.2026
|
Yesafili
|
|
Biosimilar Collaborations Ireland Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland
|
|
EU/1/23/1751
|
23.9.2026
|
|
21.9.2026
|
Cejemly
|
|
CStone Pharmaceuticals Ireland Limited
|
|
117-126 Sheriff Street Upper Dublin 1, D01 YC43, Ireland
|
|
EU/1/24/1833
|
28.9.2026
|
|
21.9.2026
|
Daptomycin Hospira
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/17/1175
|
23.9.2026
|
|
21.9.2026
|
ELREXFIO
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/23/1770
|
22.9.2026
|
|
21.9.2026
|
Padcev
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1615
|
22.9.2026
|
|
21.9.2026
|
Svariya
|
|
PGF Pharma International d.o.o.
|
|
Ulica Roberta Frangeša Mihanovića 9, 10110 Zagreb, Hrvatska
|
|
EU/1/25/1994
|
22.9.2026
|
|
21.9.2026
|
Wegovy
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/21/1608
|
24.9.2026
|
|
25.9.2026
|
Briumvi
|
|
Neuraxpharm Pharmaceuticals, S.L.
|
|
Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España
|
|
EU/1/23/1730
|
6.10.2026
|
|
25.9.2026
|
Champix
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/06/360
|
28.9.2026
|
|
25.9.2026
|
Humira
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/03/256
|
28.9.2026
|
|
25.9.2026
|
Imlygic
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/15/1064
|
28.9.2026
|
|
25.9.2026
|
Lacosamide Adroiq
|
|
Extrovis EU Kft.
|
|
Raktarvarosi Ut 9, Torokbalint, 2045, Magyarország
|
|
EU/1/23/1732
|
2.10.2026
|
|
25.9.2026
|
Ozurdex
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/10/638
|
28.9.2026
|
|
25.9.2026
|
RIULVY
|
|
Neuraxpharm Pharmaceuticals, S.L.
|
|
Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España
|
|
EU/1/25/1947
|
6.10.2026
|
|
25.9.2026
|
Sialanar
|
|
Proveca Pharma Limited
|
|
2 Dublin Landings, North Wall Quay, Dublin 1, Ireland
|
|
EU/1/16/1135
|
14.10.2026
|
|
25.9.2026
|
Usymro
|
|
Gedeon Richter Plc.
|
|
Gyömrői út 19-21, 1103 Budapest, Magyarország
|
|
EU/1/25/1957
|
28.9.2026
|
|
25.9.2026
|
Vaxelis
|
|
MCM Vaccine B.V.
|
|
Robert Boyleweg 4, 2333 CG Leiden, Nederland
|
|
EU/1/15/1079
|
5.10.2026
|
|
25.9.2026
|
Vizamyl
|
|
GE Healthcare AS
|
|
Nycoveien 1, 0485, Oslo, Norge
|
|
EU/1/14/941
|
9.10.2026
|
|
25.9.2026
|
ZINPLAVA
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/16/1156
|
28.9.2026
|
|
28.9.2026
|
Baiama
|
|
Formycon AG
|
|
Fraunhoferstraße 15, 82152 Martinsried/Planegg, Deutschland
|
|
EU/1/24/1887
|
29.9.2026
|
|
28.9.2026
|
Cegfila
|
|
Mundipharma Corporation (Ireland) Limited
|
|
United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
|
|
EU/1/19/1409
|
29.9.2026
|
|
29.9.2026
|
Nexviadyme
|
|
Sanofi B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/21/1579
|
6.10.2026
|
