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Pubblicazioni dal 17/09/2026 06:25 a ora — 26 news

Gazzetta Ufficiale – Serie Generale (6)

AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di latanoprost, «Latanoprost Stulln». (26A04820)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di amifampridina, «Amifampridina Amarox». (26A04821)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Revoca, su rinuncia, dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Icatibant Zentiva». (26A04822)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Revoca, su rinuncia, dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Meloxicam Mylan Generics». (26A04823)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di letrozolo, «Letrozolo Sandoz Gmbh» (26A04841)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di candesartan cilexetil e amlodipina, «Candesartan e Amlodipina Zentiva». (26A04857)
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EMA – What's new (9)

Plasma master file timetable: 60-day - Period 2026-2028
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Plasma master file timetable: 30-day - Period 2026-2028
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Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Date of authorisation: 13/02/2017, Revision: 28, Status: Authorised
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Human medicines European public assessment report (EPAR): Qinlock, ripretinib, Date of authorisation: 18/11/2021, Revision: 11, Status: Authorised
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Human medicines European public assessment report (EPAR): Grasustek, pegfilgrastim, Date of authorisation: 20/06/2019, Revision: 9, Status: Authorised
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Human medicines European public assessment report (EPAR): Fintepla, fenfluramine, Date of authorisation: 18/12/2020, Revision: 18, Status: Authorised
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Human medicines European public assessment report (EPAR): Vevzuo, denosumab, Date of authorisation: 25/06/2025, Revision: 4, Status: Authorised
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Human medicines European public assessment report (EPAR): Denbrayce, denosumab, Date of authorisation: 26/06/2025, Revision: 3, Status: Authorised
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Human medicines European public assessment report (EPAR): Paxneury, guanfacine, Date of authorisation: 26/02/2025, Revision: 2, Status: Authorised
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HMA – Human Medicines (1)

Added in September 2026 16 September CORRECTION - 24-25 February CMDh minutes 14 September NEW - 15-17 September CMDh…
Added in September 2026 16 September CORRECTION - 24-25 February CMDh minutes 14 September NEW - 15-17 September CMDh Agenda Added in August 2026 04 August UPDATE - Guidance published by Member States on the implementation of the Falsified Medicines Directive Added in July 2026 29 July NEW - Report from the meeting held on 21-22 July 2026UPDATE - Template of letter of intent for the submission of a worksharing procedureUPDATE - EMA/CMDh Explanatory notes on Variation Application Form - Human…
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EU Union Register of Medicinal Products (9)

Sugammadex Adroiq (Extrovis EU Kft.)
Sugammadex Adroiq (Active substance: sugammadex) - Centralised - Yearly update - Commission Decision (2026) 6615 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000371438
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Tasmar (Viatris Healthcare Limited)
Tasmar (Active substance: Tolcapone) - Centralised - Yearly update - Commission Decision (2026) 6627 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000371314
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Herwenda (Sandoz GmbH)
Herwenda (Active substance: trastuzumab) - Centralised - Yearly update - Commission Decision (2026) 6614 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000370810
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Xaluprine (Lipomed GmbH)
Xaluprine (Active substance: Mercaptopurine) - Centralised - Yearly update - Commission Decision (2026) 6626 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000369099
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Lazcluze (Janssen-Cilag International NV)
Lazcluze (Active substance: lazertinib) - Centralised - Yearly update - Commission Decision (2026) 6625 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000367563
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Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)
Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2026) 6586 of Fri, 11 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/VRA/0000343054/WS
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Riluzole Zentiva (Zentiva k.s.)
Riluzole Zentiva (Active substance: Riluzole) - Centralised - Yearly update - Commission Decision (2026) 6582 of Fri, 11 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000371092
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Rivaroxaban Accord (Accord Healthcare S.L.U.)
Rivaroxaban Accord (Active substance: rivaroxaban) - Centralised - Yearly update - Commission Decision (2026) 6579 of Fri, 11 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000370861
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Wezenla (Amgen Technology (Ireland) UC)
Wezenla (Active substance: Ustekinumab) - Centralised - 2-Monthly update - Commission Decision (2026) 6581 of Fri, 11 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/VR/0000357811
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AboutPharma – Legal & Regulatory (1)

Influenza: 9 i vaccini autorizzati per la stagione 2026-2027
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