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Pubblicazioni dal 04/09/2026 06:25 a ora — 42 news

AIFA (3)

Sunset Clause - integrazione al warning del 6 agosto 2026
La comunicazione costituisce un pre-avviso di decadenza e contiene un elenco dei medicinali in potenziale decadenza per mancata commercializzazione.
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Aggiornamenti dal PRAC: riunione del 31 agosto – 3 settembre 2026
Aggiornamenti importanti dal Comitato per la valutazione dei rischi in farmacovigilanza (PRAC) - Riunione del 31 agosto - 3 settembre 2026.
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Ordine del giorno riunione Commissione Scientifica e Economica del Farmaco (CSE)
L'Agenzia Italiana del Farmaco rende disponibile l'ordine del giorno dei lavori della riunione della Commissione Scientifica e Economica (CSE) dell'11-14 settembre 2026.
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Gazzetta Ufficiale – Serie Generale (2)

AGENZIA ITALIANA DEL FARMACO - DETERMINA 20 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 ranibizumab, «Epruvy». (Determina n. 1182/2026). (26A04550)
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AGENZIA ITALIANA DEL FARMACO - DETERMINA 20 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 maralixibat cloruro, «Livmarli». (Determina n. 1183/2026). (26A04551)
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EMA – News & press releases (2)

New EU supply chain to end Visudyne shortage
A new supply chain for Visudyne (verteporfin) has been put in place in the European Union (EU), marking an important step towards resolving a long-standing shortage of the…, This situation shows the complexity of shortages and how coordination between the European Commission, EU Member States, MSSG and SPOC Working Party can ensure fair…, Medicine shortages can have serious consequences for patients and public health and place a heavy burden on healthcare systems. The limited availability of…
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026
Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicinesEMA’s safety committee, PRAC, has started a review of injectable…, Agenda Agenda of the PRAC meeting 31 August - 3 September 2026Draft Reference Number: EMA/PRAC/164465/2026…, PRAC statistics: September 2026 Monthly figures for PRAC outcomes based on the draft agenda. @ European Medicines Agency, PRAC statistics:…, Ongoing referrals Procedure: Injectable medicines containing iron,…
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EMA – What's new (28)

Minutes of PRAC meeting on 8-11 June 2026
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EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal
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Scientific and technical recommendations: Veterinary Medicines Regulation
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Pharmaceutical industry: Getting involved in EMA activities
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Framework for interaction with pharmaceutical industry stakeholders
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Scientific advice and protocol assistance
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Human medicines European public assessment report (EPAR): Repatha, evolocumab, Date of authorisation: 17/07/2015, Revision: 28, Status: Authorised
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Executive Director's speech at Duke-NUS Medical School in Singapore
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Referral: Parenteral iron-containing medicinal products, ferric carboxymaltose,ferric derisomaltose,ferric gluconate,ferric hydroxide polymaltose complex,iron dextran,iron sucrose Article 31 referrals Procedure started
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Opinion/decision on a Paediatric investigation plan (PIP): Skyclarys, omaveloxolone, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000338563
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Human medicines European public assessment report (EPAR): Qdenga, dengue tetravalent vaccine (live, attenuated), Date of authorisation: 05/12/2022, Revision: 9, Status: Authorised
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PSUSA/00000378/202601
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PSUSA/00010510/202601
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Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 18, Status: Authorised
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Pharmacogenomics
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Union Product Database: release notes
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Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 16, Status: Authorised
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Human medicines European public assessment report (EPAR): Miglustat Dipharma, miglustat, Date of authorisation: 18/02/2019, Revision: 9, Status: Authorised
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Guidance for applicants on how to submit ePI in centralised procedures
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Targeted signal management (TSM) for Phenobarbital in cats and dogs
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Signal management (veterinary medicines)
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PSUSA/00010465/202512
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PSUSA/00000269/202601
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Visudyne
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PSUSA/00001345/202512
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PSUSA/00000495/202601
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PSUSA/00002695/202601
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Human medicines European public assessment report (EPAR): Symtuza, darunavir,cobicistat,emtricitabine,tenofovir alafenamide, Date of authorisation: 21/09/2017, Revision: 19, Status: Authorised
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EU Union Register of Medicinal Products (3)

Cimalgex (Vétoquinol SA)
Cimalgex (Active substance: Cimicoxib) - Centralised - Variation - Commission Decision (2026) 6155 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VRA/0000349171
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Mometamax Ultra (Intervet International B.V.)
Mometamax Ultra (Active substance: gentamicin, posaconazole, mometasone furoate) - Centralised - Variation - Commission Decision (2026) 6158 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VRA/0000350766
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Bexatil (Elanco GmbH)
Bexatil (Active substance: bexagliflozin) - Centralised - Authorisation - Commission Decision (2026) 6153 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMEA/V/C/006300/0000
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AboutPharma – Legal & Regulatory (4)

Acque reflue: Egualia chiede la sospensione dell’attuazione del sistema Epr
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L’Ema approva un nuovo farmaco orale a rilascio modificato di levodopa/carbidopa contro le discinesie associate al Parkinson
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Degenerazione maculare umida: una nuova supply chain europea per superare la carenza di Visudyne
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Ferro iniettabile, l’Ema riapre il dossier sicurezza: rischio ipofosfatemia e osteomalacia
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