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Pubblicazioni dal 21/08/2026 06:25 a ora — 69 news

AIFA (1)

Aggiornamento "Diario di bordo sulla Trasparenza"
L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 21/08/2026.
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Gazzetta Ufficiale – Serie Generale (7)

AGENZIA ITALIANA DEL FARMACO - DETERMINA 5 agosto 2026
Classificazione, ai sensi dell'articolo 12, comma 5, della legge 8 novembre 2012, n. 189, del medicinale per uso umano, a base di rituximab, «Truxima». (Determina n. 1122/2026). (26A04239)
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AGENZIA ITALIANA DEL FARMACO - DETERMINA 5 agosto 2026
Classificazione, ai sensi dell'articolo 12, comma 5, della legge 8 novembre 2012, n. 189, del medicinale per uso umano, a base di ciclosporina, «Vevizye». (Determina n. 1123/2026). (26A04240)
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AGENZIA ITALIANA DEL FARMACO - DETERMINA 5 agosto 2026
Classificazione, ai sensi dell'articolo 12, comma 5, della legge 8 novembre 2012, n. 189, del medicinale per uso umano, a base di eltrombopag, «Eltrombopag Viatris». (Determina n. 1124/2026). (26A04241)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di alfacalcidolo, «Sefal». (26A04211)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'importazione parallela del medicinale per uso umano «Zarontin» (26A04242)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'importazione parallela del medicinale per uso umano «Becozym» (26A04243)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'importazione parallela del medicinale per uso umano «Stilnox» (26A04244)
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EMA – What's new (59)

Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
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Human medicines European public assessment report (EPAR): Zilbrysq, zilucoplan, Date of authorisation: 01/12/2023, Revision: 5, Status: Authorised
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EMA risk management information day, European Medicines Agency, Amsterdam, the Netherlands, from 8 September 2026, 09:00 (CEST) to 8 September 2026, 17:00 (CEST)
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Human medicines European public assessment report (EPAR): Vabysmo, faricimab, Date of authorisation: 15/09/2022, Revision: 10, Status: Authorised
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Orphan designation: florbetaben (18F) Diagnosis of AL amyloidosis, 22/04/2020 Positive
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Orphan designation: 2-(2-(18F)fluoropyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine Diagnosis of progressive supranuclear palsy, 21/08/2020 Positive
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Orphan designation: 2-(2-(18F)fluoropyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine Diagnosis of corticobasal degeneration, 19/10/2020 Positive
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Orphan designation: florbetaben (18F) Diagnosis of ATTR amyloidosis, 22/05/2025 Positive
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Orphan designation: 2,4,6,7,8,9-hexahydro-4-((2-methylphenyl)methyl)-7-(phenylmethyl)imidazo(1,2-a)pyrido(3,4-e)pyrimidin-5(1H)-one Treatment of glioma, 18/07/2022 Positive
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Human medicines European public assessment report (EPAR): Ngenla, somatrogon, Date of authorisation: 14/02/2022, Revision: 9, Status: Authorised
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Human medicines European public assessment report (EPAR): Aripiprazole Sandoz, aripiprazole, Date of authorisation: 20/08/2015, Revision: 14, Status: Authorised
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Report - Quality Innovation Group (QIG): Listen and learn focus group meeting on sustainability
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Human medicines European public assessment report (EPAR): Oxbryta, voxelotor, Date of authorisation: 14/02/2022, Revision: 7, Status: Suspended
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Human medicines European public assessment report (EPAR): Artesunate Amivas, artesunate, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised
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Orphan designation: 5-fluoro-4-(7'-fluoro-2'-methylspiro[cyclopentane-1,3'-indol]-5'-yl)-N-(5-(1-methylpiperidin-4-yl)pyridin-2-yl)pyrimidin-2-amine,crozbaciclib Treatment of glioma, 26/03/2021 Withdrawn
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Orphan designation: Eculizumab Treatment of Guillain-Barré syndrome, 11/10/2022 Withdrawn
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Orphan designation: N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide Treatment of hepatocellular carcinoma, 23/08/2017 Withdrawn
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Orphan designation: amatuximab Treatment of malignant mesothelioma, 16/01/2014 Withdrawn
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Human medicines European public assessment report (EPAR): Krazati, adagrasib, Date of authorisation: 05/01/2024, Revision: 4, Status: Authorised
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Orphan designation: Humanised monoclonal antibody to the folate receptor alpha Treatment of ovarian cancer, 01/04/2008 Withdrawn
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Orphan designation: serdexmethylphenidate Treatment of idiopathic hypersomnia, 24/05/2024 Withdrawn
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PSUSA/00000633/202504
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Orphan designation: human MHC non-restricted cytotoxic T-cell line Treatment of ovarian cancer, 30/11/2009 Withdrawn
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Human medicines European public assessment report (EPAR): Cenrifki, tolebrutinib, Date of authorisation: 19/06/2026, Revision: 1, Status: Authorised
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Human medicines European public assessment report (EPAR): Imaavy, nipocalimab, Date of authorisation: 28/11/2025, Revision: 1, Status: Authorised
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Human medicines European public assessment report (EPAR): Veoza, fezolinetant, Date of authorisation: 07/12/2023, Revision: 7, Status: Authorised
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Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Date of authorisation: 18/05/2020, Revision: 23, Status: Authorised
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Human medicines European public assessment report (EPAR): Tuyory, tocilizumab, Date of authorisation: 27/04/2026, Revision: 2, Status: Authorised
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Human medicines European public assessment report (EPAR): Enspryng, satralizumab, Date of authorisation: 24/06/2021, Revision: 9, Status: Authorised
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Human medicines European public assessment report (EPAR): Eylea, aflibercept, Date of authorisation: 21/11/2012, Revision: 40, Status: Authorised
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Human medicines European public assessment report (EPAR): Isembyld, apitegromab, Status: Application withdrawn
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Human medicines European public assessment report (EPAR): Rystiggo, rozanolixizumab, Date of authorisation: 05/01/2024, Revision: 10, Status: Authorised
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Orphan designation: human anti-promyostatin monoclonal antibody (apitegromab) Treatment of spinal muscular atrophy, 14/12/2018 Positive
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Orphan designation: 2-(2-Chlorobenzylidene)hydrazinecarboximidamide acetate Treatment of Charcot-Marie-Tooth disease, 14/12/2015 Positive
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Orphan designation: Icerguastat acetate Treatment of amyotrophic lateral sclerosis, 16/05/2022 Positive
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Orphan designation: chenodeoxycholic acid Treatment of inborn errors in primary bile acid synthesis, 16/12/2014 Positive
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Orphan designation: setanaxib Treatment of Alport syndrome, 08/11/2023 Positive
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Orphan designation: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione Treatment of systemic sclerosis, 09/10/2015 Positive
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Orphan designation: setanaxib Treatment of primary biliary cholangitis, 06/01/2021 Positive
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Orphan designation: ziftomenib Treatment of acute myeloid leukaemia, 12/01/2024 Positive
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Orphan designation: daraxonrasib Treatment of pancreatic cancer, 20/04/2026 Positive
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Orphan designation: edaravone Treatment of amyotrophic lateral sclerosis, 19/06/2015 Positive
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Orphan designation: Treatment of Leber’s hereditary optic neuropathy, 14/01/2022 Positive
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Orphan designation: 7-ethyl-10-hydroxy-camptothecin,irinotecan hydrochloride trihydrate Treatment of small cell lung cancer, 24/05/2024 Positive
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Orphan designation: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione Treatment of idiopathic pulmonary fibrosis, 26/11/2010 Positive
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Orphan designation: human IgG1 monoclonal antibody against hepatitis B virus, surface antigen Treatment of hepatitis D virus infection, 28/06/2024 Positive
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Orphan designation: adeno-associated viral vector serotype 2 containing the human CHM gene encoding human Rab escort protein 1 Treatment of choroideraemia, 04/06/2014 Positive
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Orphan designation: guanabenz acetate Treatment of vanishing white matter disease, 20/03/2023 Positive
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Orphan designation: milademetan tosilate monohydrate Treatment of soft tissue sarcoma, 20/03/2017 Withdrawn
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Orphan designation: adeno-associated virus vector serotype 1 containing the human GRN gene Treatment of frontotemporal dementia, 19/07/2021 Withdrawn
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Orphan designation: Letermovir Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity, 06/06/2012 Withdrawn
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Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide Treatment of schwannoma, 06/06/2012 Withdrawn
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Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide Treatment of meningioma, 06/06/2012 Withdrawn
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Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Date of authorisation: 25/04/2016, Revision: 22, Status: Authorised
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Orphan designation: (S)-12-fluoro-4-(2-methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H-[1,2,4]triazolo[4',3':1,6]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine Treatment of sickle cell disease, 16/03/2022 Withdrawn
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Orphan designation: carbetocin Treatment of Prader-Willi syndrome, 21/03/2012 Withdrawn
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Orphan designation: Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus musculus monoclonal hRS7 κ-chain, dimer, hexakis(thioether) with (4S)-4-[[[[4-[[(2S)-2-(4-aminobutyl)-2-[[2-[2-[[26-[4-[[[[4-[(3-mercapto-2,5-dioxo-1-pyrrolidinyl)methyl]cyclohexyl]carbonyl]amino]methyl]-1H-1,2,3-triazol-1-yl]-3,6,9,12,15,18,21,24-octaoxahexacos-1-yl]amino]-2-oxoethoxy]acetyl]amino]-1-oxoethyl]amino]phenyl]methoxy]carbonyl]oxy]-4,11-diethyl-9-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (sacituzumab govitecan) Treatment of pancreatic cancer, 15/10/2014 Withdrawn
Orphan designation: Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus musculus monoclonal hRS7 κ-chain, dimer, hexakis(thioether) with…
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Human medicines European public assessment report (EPAR): Ondibta, insulin glargine, Date of authorisation: 09/01/2026, Revision: 3, Status: Authorised
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Human medicines European public assessment report (EPAR): Rimmyrah, ranibizumab, Date of authorisation: 05/01/2024, Revision: 6, Status: Authorised
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EU Union Register of Medicinal Products (2)

Comirnaty (BioNTech Manufacturing GmbH)
Comirnaty (Active substance: COVID-19 mRNA vaccine) - Rectificative Decision - Commission Decision (2026) 5921 of Mon, 17 Aug 2026
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Stelara (Janssen Cilag International N.V.)
Stelara (Active substance: ustekinumab) - Centralised - 2-Monthly update - Commission Decision (2026) 5463 of Thu, 23 Jul 2026 - European Medicines Agency (EMA) procedure number: EMA/VR/0000316205
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