Union européenne — décisions de la Commission européenne
Retraits et suspensions d'AMM, rappels de lots, ruptures de stock, informations de sécurité, remboursement et nouveaux médicaments — chaque jour, automatiquement. Dernière mise à jour : 09/11/2026 07:50.
Sources : nous suivons les changements à partir de la Base de données publique des médicaments (AMM, commercialisation, disponibilité, taux et prix de remboursement, informations importantes), comparée chaque jour à l'état précédent, et des informations de sécurité de l'ANSM (rappels de lots). Les décisions sur les médicaments autorisés par procédure centralisée proviennent du Registre de l'Union de la Commission européenne (badge UE). Alternatives (même groupe générique ou même substance active) : base de données Lekoskop.
n° EU/1/00/156 · autorisé le 28/12/2000 · Trizivir is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults (see section… · ViiV Healthcare BV · abacavir, lamivudine, zidovudine · ATC J05AR02
n° EU/1/22/1695 · autorisé le 20/12/2022 · Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse l… · Swedish Orphan Biovitrum AB (publ) · loncastuximab tesirine · ATC L01FX22
n° EU/1/24/1801 · autorisé le 19/04/2024 · Plaque psoriasis
Pyzchiva is indicated for the treatment of moderate to severe plaque psoriasis in adults who… · Samsung Bioepis NL B.V. · ustekinumab · ATC L04AC05
n° EU/1/18/1282 · autorisé le 16/05/2018 · Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who a… · ViiV Healthcare B.V. · dolutegravir / rilpivirine · ATC J05AR21
n° EU/1/11/708 · autorisé le 18/08/2011 · Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa f… · Orion Corporation · entacapone · ATC N04BX02
n° EU/1/18/1352 · autorisé le 15/02/2019 · Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic sple… · AOP Orphan Pharmaceuticals GmbH · ropeginterferon alfa-2b · ATC L03AB15
n° EU/1/15/1004 · autorisé le 27/05/2015 · Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 yea… · Hikma Farmacêutica (Portugal), S.A. · voriconazole · ATC J02AC03
n° EU/1/22/1675 · autorisé le 23/08/2022 · TECVAYLI is indicated
• in combination with daratumumab for the treatment of adult patients with relapsed or… · Janssen-Cilag International NV · teclistamab · ATC L01F
n° EU/1/98/082 · autorisé le 16/09/1998 · Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa f… · Orion Corporation · entacapone · ATC N04BX02
n° EU/1/11/698 · autorisé le 13/07/2011 · Melanoma
YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced … · Bristol-Myers Squibb Pharma EEIG · ipilimumab · ATC L01FX04
n° EU/1/21/1576 · autorisé le 22/11/2021 · BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia… · BeOne Medicines Netherlands B.V. · zanubrutinib · ATC L01EL03
n° EU/1/01/198 · autorisé le 27/08/2001 · Glivec is indicated for the treatment of
- adult and paediatric patients with newly diagnosed Philadelphia ch… · Novartis Europharm Limited · Imatinib · ATC L01EA01
n° EU/1/20/1441 · autorisé le 30/05/2020 · Bemrist Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age… · Novartis Europharm Limited · indacaterol / mometasone furoate · ATC R03AK
n° EU/1/14/980 · autorisé le 15/01/2015 · Adult plaque psoriasis
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adul… · Novartis Europharm Limited · secukinumab · ATC L04AC10
n° EU/1/06/336 · autorisé le 24/04/2006 · Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following … · Pfizer Europe MA EEIG · Tigecycline · ATC J01AA12
n° EU/1/08/442 · autorisé le 18/03/2008 · Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total h… · Boehringer Ingelheim International GmbH · dabigatran etexilate mesilate · ATC B01AE07
n° EU/1/07/418 · autorisé le 18/09/2007 · CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced… · ViiV Healthcare BV · maraviroc · ATC J05AX09
n° EU/1/09/600 · autorisé le 30/11/2009 · Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one w… · Biotest Pharma GmbH · Human Hepatitis B Immunoglobulin · ATC J06BB04
n° EU/1/25/1974 · autorisé le 22/12/2025 · WAYRILZ is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory t… · Sanofi B.V. · rilzabrutinib · ATC Pending
n° EU/1/22/1645 · autorisé le 25/04/2022 · Vydura is indicated for the
• Acute treatment of migraine with or without aura in adults;
• Preventive trea… · Pfizer Europe MA EEIG · rimegepant · ATC N02CD
n° EU/1/20/1481 · autorisé le 17/12/2020 · Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunod… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
n° EU/1/20/1452 · autorisé le 25/06/2020 · Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and in… · Bristol-Myers Squibb Pharma EEIG · luspatercept · ATC B03XA06
n° EU/1/17/1191 · autorisé le 08/05/2017 · Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who ha… · Recordati Netherlands B.V. · dinutuximab beta · ATC L01FX06
n° EU/1/15/1024 · autorisé le 17/07/2015 · Melanoma
KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and o… · Merck Sharp & Dohme B.V. · pembrolizumab · ATC L01FF02
n° EU/1/18/1337 · autorisé le 11/01/2019 · This medicinal product is for diagnostic use only.
GHRYVELIN is indicated for the diagnosis of growth hormone… · Atnahs Pharma Netherlands B.V. · macimorelin · ATC V04CD06
n° EU/1/20/1508 · autorisé le 18/01/2021 · <u>Breast cancer</u>
<i>HER2-positive breast cancer</i>
Enhertu in combination with pertuzumab is indicate… · Daiichi Sankyo Europe GmbH · trastuzumab deruxtecan · ATC L01FD04
n° EU/1/97/053 · autorisé le 17/11/1997 · Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confir… · Sanofi B.V. · imiglucerase · ATC A16AB02
n° EU/1/24/1851 · autorisé le 19/09/2024 · Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults and adolescen… · LEO Pharma A/S · delgocitinib · ATC D11AH11
n° EU/1/17/1231 · autorisé le 08/01/2018 · Ocrevus is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with … · Roche Registration GmbH · ocrelizumab · ATC L04AG08
n° EU/1/11/676 · autorisé le 17/03/2011 · JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with m… · Sanofi Winthrop Industrie · cabazitaxel · ATC L01CD04
n° EU/1/24/1872 · autorisé le 12/12/2024 · Adult Crohn’s disease
IMULDOSA is indicated for the treatment of adult patients with moderately to severely … · Accord Healthcare S.L.U. · ustekinumab · ATC L04AC05
n° EU/1/23/1760 · autorisé le 15/09/2023 · Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce th… · ViiV Healthcare BV · cabotegravir · ATC J05AJ04
Lekoskop