Osservatorio Regolatorio Pharma – 03/09/2026 (32 news)

[Osservatorio Regolatorio Pharma]

Osservatorio Regolatorio Pharma

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Pubblicazioni dal 02/09/2026 06:25 a ora — 32 news

EMA – What's new (22)

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

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Assessment templates and guidance (veterinary medicines)

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Saxenda

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Template - CVMP member comments on rapporteur’s reports

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Information required for early identification of a need for pre-authorisation GMP inspections

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Brevibloc

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Pre-submission interactions model pilot

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Pre-submission interactions form for marketing authorisation application

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Human medicines European public assessment report (EPAR): Yaxwer, denosumab, Date of authorisation: 23/06/2025, Revision: 2, Status: Authorised

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Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Date of authorisation: 22/03/2018, Revision: 13, Status: Authorised

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Women's health

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Human medicines European public assessment report (EPAR): Cibinqo, abrocitinib, Date of authorisation: 09/12/2021, Revision: 18, Status: Authorised

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Human medicines European public assessment report (EPAR): Ngenla, somatrogon, Date of authorisation: 14/02/2022, Revision: 11, Status: Authorised

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Human medicines European public assessment report (EPAR): Rebif, interferon beta-1a, Date of authorisation: 03/05/1998, Revision: 43, Status: Authorised

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Human medicines European public assessment report (EPAR): Prasugrel Viatris (previously Prasugrel Mylan), prasugrel, Date of authorisation: 15/05/2018, Revision: 14, Status: Authorised

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Human medicines European public assessment report (EPAR): Ogsiveo, nirogacestat, Date of authorisation: 14/08/2025, Revision: 4, Status: Authorised

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Human medicines European public assessment report (EPAR): Ezmekly, mirdametinib, Date of authorisation: 17/07/2025, Revision: 4, Status: Authorised

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Human medicines European public assessment report (EPAR): Cinacalcet Accordpharma, cinacalcet, Date of authorisation: 03/04/2020, Revision: 6, Status: Authorised

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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes

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Veterinary medicines European public assessment report (EPAR): Bexatil, Bexagliflozin, Status: Authorised

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Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine,tenofovir disoproxil, Date of authorisation: 09/11/2016, Revision: 11, Status: Authorised

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EU Union Register of Medicinal Products (9)

Zoledronic acid Mylan (Mylan Pharmaceuticals Limited)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2026) 6173 of Fri, 28 Aug 2026

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Enhertu (Daiichi Sankyo Europe GmbH)

Enhertu (Active substance: trastuzumab deruxtecan) - Centralised - 2-Monthly update - Commission Decision (2026) 6169 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VR/0000322236

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Reconcile (FORTE Healthcare Ltd)

Reconcile (Active substance: Fluoxetine) - Centralised - Variation - Commission Decision (2026) 6157 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VRA/0000322711

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Cibinqo (Pfizer Europe MA EEIG)

Cibinqo (Active substance: abrocitinib) - Centralised - Renewal - Commission Decision (2026) 6160 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/R/0000336009

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Saxenda (Novo Nordisk A/S)

Saxenda (Active substance: liraglutide) - Centralised - Yearly update - Commission Decision (2026) 6170 of Fri, 28 Aug 2026

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Ximluci (STADA Arzneimittel AG)

Ximluci (Active substance: ranibizumab) - PSUSA - Modification - Commission Decision (2026) 5987 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000327906

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Dasatinib Accord Healthcare (Accord Healthcare S.L.U.)

Dasatinib Accord Healthcare (Active substance: dasatinib) - Centralised - Yearly update - Commission Decision (2026) 5977 of Thu, 20 Aug 2026

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Vyndaqel (Pfizer Europe MA EEIG)

Vyndaqel (Active substance: tafamidis) - Centralised - Variation - Commission Decision (2026) 5984 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/X/0000287968

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Cabazitaxel Accord (Accord Healthcare S.L.U.)

Cabazitaxel Accord (Active substance: cabazitaxel) - Centralised - Yearly update - Commission Decision (2026) 5979 of Thu, 20 Aug 2026

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AboutPharma – Legal & Regulatory (1)

Dermatite atopica: Aifa estende la rimborsabilità di upadacitinib agli adolescenti dai 12 anni

L’Agenzia italiana del farmaco ha approvato la rimborsabilità di upadacitinib, inibitore orale e selettivo di JAK, per il trattamento della dermatite atopica da moderata a grave negli adolescenti a…

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