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Pubblicazioni dal 25/08/2026 06:25 a ora — 31 news

Gazzetta Ufficiale – Serie Generale (4)

AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Numeta» (26A04267)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di rosuvastatina, «Rosuvastatina Mylan Italia». (26A04268)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di sodio alginato e sodio bicarbonato, «Gaviscon». (26A04269)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di ramipril, «Ramipril EG». (26A04270)
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EMA – What's new (19)

Webinar on the use of platform approaches in the non-clinical and clinical domains, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 2 March 2026, 09:25 (CET) to 2 March 2026, 12:30 (CET)
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Annex to 8-11 December 2025 CHMP Minutes
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Annex to 10-13 November 2025 CHMP Minutes
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Annex to 13-16 October 2025 CHMP Minutes
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Minutes of the CHMP meeting 8-11 December 2025
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Minutes of the CHMP meeting 10-13 November 2025
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Minutes of the CHMP meeting 13-16 October 2025
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Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Date of authorisation: 26/08/2010, Revision: 22, Status: Authorised
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Human medicines European public assessment report (EPAR): Zinmyleo, trilaciclib, Status: Application withdrawn
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Human medicines European public assessment report (EPAR): Aquipta, atogepant, Date of authorisation: 11/08/2023, Revision: 7, Status: Authorised
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Veterinary medicines European public assessment report (EPAR): Nobivac NXT HCPChFeLV, feline calicivirosis, feline rhinotracheitis, feline panleucopenia, feline chlamydiosis (live) and feline leukemia (self-amplifying RNA particle) vaccine, Status: Authorised
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Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Date of authorisation: 26/09/2018, Revision: 20, Status: Authorised
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Human medicines European public assessment report (EPAR): Liraglutide STADA, liraglutide, Date of authorisation: 15/07/2026, Status: Authorised
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Human medicines European public assessment report (EPAR): Rezurock, belumosudil, Date of authorisation: 24/03/2026, Revision: 1, Status: Authorised
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Human medicines European public assessment report (EPAR): Hopledo, levodopa,carbidopa, Date of authorisation: 20/08/2026, Status: Authorised
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Human medicines European public assessment report (EPAR): Ablymico, liraglutide, Date of authorisation: 15/07/2026, Status: Authorised
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Human medicines European public assessment report (EPAR): Akynzeo, netupitant,palonosetron, Date of authorisation: 27/05/2015, Revision: 23, Status: Authorised
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Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Date of authorisation: 08/02/2018, Revision: 22, Status: Authorised
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Human medicines European public assessment report (EPAR): Zutectra, human hepatitis B immunoglobulin, Date of authorisation: 30/11/2009, Revision: 20, Status: Authorised
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EU Union Register of Medicinal Products (8)

Rimmyrah (QILU PHARMA SPAIN S.L.)
Rimmyrah (Active substance: ranibizumab) - PSUSA - Modification - Commission Decision (2026) 5991 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: PSUSA/00002609/202510
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VeroBlue-3 (VEROVACCiNES GmbH)
VeroBlue-3 (Active substance: Bluetongue virus vaccine (inactivated)) - Centralised - Variation - Commission Decision (2026) 5993 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VRA/0000350624
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Benlysta (GlaxoSmithKline (Ireland) Limited)
Benlysta (Active substance: belimumab) - PASS - Modification - Commission Decision (2026) 5971 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/PASS/0000306411
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Lacosamide Accord (Accord Healthcare S.L.U.)
Lacosamide Accord (Active substance: lacosamide) - Centralised - Yearly update - Commission Decision (2026) 5978 of Thu, 20 Aug 2026
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IXCHIQ (Valneva Austria GmbH)
IXCHIQ (Active substance: Chikungunya vaccine (live)) - PSUSA - Modification - Commission Decision (2026) 5919 of Mon, 17 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000327923
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Trodelvy (Gilead Sciences Ireland UC)
Trodelvy (Active substance: sacituzumab govitecan) - Centralised - 2-Monthly update - Commission Decision (2026) 6019 of Fri, 21 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VR/0000320818
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Ultomiris (Alexion Europe SAS)
Ultomiris (Active substance: Ravulizumab) - Centralised - Yearly update - Commission Decision (2026) 6021 of Fri, 21 Aug 2026
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Jinarc (Otsuka Pharmaceutical Netherlands B.V.)
Jinarc (Active substance: tolvaptan) - Centralised - Yearly update - Commission Decision (2026) 5974 of Thu, 20 Aug 2026
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