Unione europea — decisioni della Commissione europea
Revoche e sospensioni, ritiri di lotti, farmaci carenti, note di sicurezza, rimborsabilità e nuovi medicinali — ogni giorno, automaticamente. Ultimo aggiornamento: 10/11/2026 08:15.
n. EU/1/15/1004 · autorizzato il 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 · autorizzato il 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/1/14/934 · autorizzato il 18/07/2014 · Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis · Biogen Netherlands B.V. · peginterferon beta-1a · ATC L03AB13
n. EU/1/98/082 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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/1/21/1571 · autorizzato il 20/08/2021 · Abiraterone Mylan is indicated with prednisone or prednisolone for:
• the treatment of newly diagnosed meta… · Mylan Pharmaceuticals Limited · abiraterone acetate · ATC L02BX03
n. EU/1/01/198 · autorizzato il 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 · autorizzato il 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/1/18/1286 · autorizzato il 26/07/2018 · <u>Rheumatoid arthritis</u>
Hyrimoz in combination with methotrexate, is indicated for:
• the treatment … · Sandoz GmbH · adalimumab · ATC L04AB04
n. EU/1/14/980 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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/1/21/1615 · autorizzato il 13/04/2022 · <u>Muscle invasive bladder cancer (MIBC)</u>
Padcev, in combination with pembrolizumab, as neoadjuvant trea… · Astellas Pharma Europe B.V. · enfortumab vedotin · ATC L01FX13
n. EU/1/17/1231 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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 · autorizzato il 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
n. EU/1/25/1961 · autorizzato il 14/08/2025 · Vgenfli is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AM… · Zakłady Farmaceutyczne POLPHARMA S.A. · aflibercept · ATC S01LA05
n. EU/1/17/1251 · autorizzato il 08/02/2018 · Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an… · Novo Nordisk A/S · semaglutide · ATC A10BJ06
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