Apixaban product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 30 June 2025 - 10:45
Apixaban product-specific bioequivalence guidance
Acenocoumarol product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 30 June 2025 - 10:19
Acenocoumarol product-specific bioequivalence guidance
Voriconazole product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 30 June 2025 - 9:51
Voriconazole product-specific bioequivalence guidance
Periodic safety update reports (PSURs)
Submitted by Anonymous (not verified) on 30 June 2025 - 9:46
Periodic safety update reports (PSURs)
Tadalafil product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 30 June 2025 - 9:35
Tadalafil product-specific bioequivalence guidance
Repaglinide product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 30 June 2025 - 9:25
Repaglinide product-specific bioequivalence guidance
Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas - Chapter 9
Submitted by Anonymous (not verified) on 30 June 2025 - 9:14
Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas - Chapter 9
Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 17, Status: Authorised
Submitted by Anonymous (not verified) on 30 June 2025 - 9:04
Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 17, Status: Authorised
Quarterly System Demo - Q2 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 June 2025, 09:00 (CEST) to 26 June 2025, 10:45 (CEST)
Submitted by Anonymous (not verified) on 30 June 2025 - 9:00
Quarterly System Demo - Q2 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 June 2025, 09:00 (CEST) to 26 June 2025, 10:45 (CEST)
PRAC recommendations on safety signals
Submitted by Anonymous (not verified) on 30 June 2025 - 8:53
PRAC recommendations on safety signals