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Pubblicazioni dal 03/09/2026 06:25 a ora — 22 news

AIFA (1)

Aggiornamento "Diario di bordo sulla Trasparenza"
L'Agenzia Italiana del Farmaco rende disponibile on line l'aggiornamento del "Diario di Bordo sulla Trasparenza" al 03/09/2026.
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Gazzetta Ufficiale – Serie Generale (1)

AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di olmesartan medoxomil/amlodipina/idroclorotiazide, «Sarex». (26A04219)
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EMA – Regulatory & procedural guidelines (1)

EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal
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EMA – What's new (13)

Minutes of PRAC meeting on 8-11 June 2026
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Podcast: Inside EMA
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Human medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Date of authorisation: 17/07/2015, Revision: 72, Status: Authorised
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PSUSA/00000414/202601
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PSUSA/00010209/202601
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Herbal medicinal product: Fragariae folium, Fragaria vesca L., Fragaria moschata Weston,Fragaria viridis Weston,Fragaria x ananassa (Weston) Duchesne ex Rozier , F: Assessment finalised
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Human medicines European public assessment report (EPAR): Pomalidomide Krka, pomalidomide, Date of authorisation: 24/07/2024, Revision: 3, Status: Authorised
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Human medicines European public assessment report (EPAR): Velsipity, etrasimod, Date of authorisation: 16/02/2024, Revision: 4, Status: Authorised
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Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 19, Status: Authorised
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Human medicines European public assessment report (EPAR): Ambrisentan Viatris (previously Ambrisentan Mylan), ambrisentan, Date of authorisation: 20/06/2019, Revision: 10, Status: Authorised
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Human medicines European public assessment report (EPAR): Onureg, azacitidine, Date of authorisation: 17/06/2021, Revision: 5, Status: Authorised
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Sponsor guidance: New safety module on the annual safety report
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Support to SMEs
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EU Union Register of Medicinal Products (6)

BEKEMV (Amgen Technology (Ireland) UC)
BEKEMV (Active substance: eculizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2026) 6162 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/T/0000363352
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Brucellin Aquilon (CZ Vaccines S.A.U.)
Brucellin Aquilon (Active substance: Brucella abortus, strain AQ1302, protein extract) - Centralised - Variation - Commission Decision (2026) 6156 of Fri, 28 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VRA/0000343835
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BEKEMV (Amgen Technology (Ireland) UC)
BEKEMV (Active substance: eculizumab) - Centralised - Yearly update - Commission Decision (2026) 6161 of Fri, 28 Aug 2026
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Yorvipath (Ascendis Pharma Bone Diseases A/S)
Yorvipath (Active substance: palopegteriparatide) - PSUSA - Modification - Commission Decision (2026) 6123 of Thu, 27 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000327865
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Piqray (Novartis Europharm Limited)
Piqray (Active substance: alpelisib) - Centralised - 2-Monthly update - Commission Decision (2026) 6024 of Fri, 21 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/VR/0000317159
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Aujemflu (Seqirus Netherlands B.V.)
Aujemflu (Active substance: influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell cultures)) - Centralised - Authorisation - Commission Decision (2026) 5972 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMEA/H/C/006692/0000
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