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Pubblicazioni dal 08/09/2026 06:25 a ora — 28 news

Gazzetta Ufficiale – Serie Generale (4)

AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di linagliptin e metformina cloridrato, «Linagliptin e Metformina EG». (26A04655)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di dimetilfumarato, «Dimetilfumarato Medical Valley». (26A04698)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di allopurinolo, «Allopurinolo Sandoz». (26A04707)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di azitromicina, «Azeptin». (26A04708)
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EMA – Regulatory & procedural guidelines (1)

Member states contact points for translations review
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EMA – What's new (17)

EMA/FVE information session for veterinary students: the importance of pharmacovigilance, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 October 2026, 16:00 (CEST) to 13 October 2026, 17:15 (CEST)
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PSUSA/00003159/202512
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Agenda of the CVMP meeting 8-10 September 2026
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PSUSA/00010710/202601
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Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Date of authorisation: 13/02/2017, Revision: 27, Status: Authorised
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Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus 9-valent vaccine (recombinant, adsorbed), Date of authorisation: 10/06/2015, Revision: 30, Status: Authorised
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Agenda - PDCO agenda of the 8-11 September 2026 meeting
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Human medicines European public assessment report (EPAR): Vislyfa, ranibizumab, Date of authorisation: 15/07/2026, Revision: 1, Status: Authorised
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Human medicines European public assessment report (EPAR): Lupkynis, voclosporin, Date of authorisation: 15/09/2022, Revision: 8, Status: Authorised
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Human medicines European public assessment report (EPAR): Kavigale, sipavibart, Date of authorisation: 20/01/2025, Revision: 5, Status: Authorised
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Human medicines European public assessment report (EPAR): Rezolsta, darunavir,cobicistat, Date of authorisation: 19/11/2014, Revision: 20, Status: Authorised
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Human medicines European public assessment report (EPAR): Benlysta, belimumab, Date of authorisation: 13/07/2011, Revision: 41, Status: Authorised
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Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Date of authorisation: 16/12/2019, Revision: 35, Status: Authorised
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Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Date of authorisation: 23/03/2015, Revision: 26, Status: Authorised
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Human medicines European public assessment report (EPAR): Suliqua, insulin glargine,lixisenatide, Date of authorisation: 11/01/2017, Revision: 16, Status: Authorised
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Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Date of authorisation: 22/01/2007, Revision: 49, Status: Authorised
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Human medicines European public assessment report (EPAR): Bexsero, meningococcal group B Vaccine (rDNA, component, adsorbed), Date of authorisation: 13/01/2013, Revision: 37, Status: Authorised
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EU Union Register of Medicinal Products (4)

EU/3/25/3121 (TMC Pharma (EU) Limited)
EU/3/25/3121 (Active substance: Brepocitinib) - Transfer of orphan designation - Commission Decision (2026) 6290 of Thu, 03 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000357356
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EU/3/22/2652 (TEVA GmbH)
EU/3/22/2652 (Active substance: 3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole) - Transfer of orphan designation - Commission Decision (2026) 6165 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000363031
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EU/3/26/3282 (PacingCure B.V.)
EU/3/26/3282 (Active substance: Adeno-associated viral vector serotype 6 containing the truncated human HCN4 gene) - Orphan designation - Commission Decision (2026) 6004 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000339184
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EU/3/26/3284 (Universitat Autònoma De Barcelona)
EU/3/26/3284 (Active substance: (4Z,7R,8E,10E,12Z,14S,16Z,19Z)-7,14-Dihydroxydocosa-4,8,10,12,16,19-hexaenoic acid) - Orphan designation - Commission Decision (2026) 6006 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000342172
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AboutPharma – Legal & Regulatory (2)

AI nelle GMP europee: in attesa dell’Annex 22 c’è già molto da fare
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Farmaci botanici: la Fda apre una consultazione per accelerarne lo sviluppo
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