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Last updated about 2 hours ago

Qualification of novel methodologies for medicinal product development: guidance to applicants

about 3 hours ago

Qualification of novel methodologies for medicinal product development: guidance to applicants

Qualification of novel methodologies for medicine development

about 3 hours ago

Qualification of novel methodologies for medicine development

Human medicines European public assessment report (EPAR): Calquence, acalabrutinib, Date of authorisation: 05/11/2020, Revision: 12, Status: Authorised

about 19 hours ago

Human medicines European public assessment report (EPAR): Calquence, acalabrutinib, Date of authorisation...

Human medicines European public assessment report (EPAR): Altuvoct, efanesoctocog alfa, Date of authorisation: 17/06/2024, Revision: 3, Status: Authorised

about 19 hours ago

Human medicines European public assessment report (EPAR): Altuvoct, efanesoctocog alfa, Date of...

Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Date of authorisation: 27/06/2006, Revision: 53, Status: Authorised

about 19 hours ago

Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Date of authorisation...

Agenda of the PRAC meeting 6-9 July 2026

about 19 hours ago

Agenda of the PRAC meeting 6-9 July 2026

Agenda of the HMPC meeting 6-8 July 2026

about 20 hours ago

Agenda of the HMPC meeting 6-8 July 2026

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Date of authorisation: 18/01/2021, Revision: 20, Status: Authorised

about 20 hours ago

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Date of...

Start of procedure: Extension of marketing authorisation (22 May 2026 - 25 June 2026)

about 22 hours ago

Start of procedure: Extension of marketing authorisation (22 May 2026 - 25...

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (22 May 2026 - 25 June 2026)

about 21 hours ago

Start of procedure: Type II Variation - Extension of indication under evaluation...