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Last updated about 4 hours ago

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment

about 4 hours ago

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices...

Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Date of authorisation: 23/07/2025, Revision: 3, Status: Authorised

about 5 hours ago

Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Date of...

Human medicines European public assessment report (EPAR): Bysumlog, insulin lispro, Date of authorisation: 06/05/2026, Revision: 1, Status: Authorised

about 5 hours ago

Human medicines European public assessment report (EPAR): Bysumlog, insulin lispro, Date of...

Human medicines European public assessment report (EPAR): Vijoice, alpelisib, Date of authorisation: 15/07/2026, Status: Authorised

about 5 hours ago

Human medicines European public assessment report (EPAR): Vijoice, alpelisib, Date of authorisation...

Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Date of authorisation: 19/09/2022, Revision: 15, Status: Authorised

about 5 hours ago

Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Date of authorisation...

Human medicines European public assessment report (EPAR): Darzalex, daratumumab, Date of authorisation: 20/05/2016, Revision: 30, Status: Authorised

about 6 hours ago

Human medicines European public assessment report (EPAR): Darzalex, daratumumab, Date of authorisation...

Orphan designation: daratumumab Treatment of AL amyloidosis, 25/05/2018 Withdrawn

about 6 hours ago

Orphan designation: daratumumab Treatment of AL amyloidosis, 25/05/2018 Withdrawn

Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Date of authorisation: 16/03/2016, Revision: 16, Status: Authorised

about 6 hours ago

Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Date of authorisation...

Human medicines European public assessment report (EPAR): Skyrizi, risankizumab, Date of authorisation: 26/04/2019, Revision: 31, Status: Authorised

about 7 hours ago

Human medicines European public assessment report (EPAR): Skyrizi, risankizumab, Date of authorisation...

Medicines for human use under evaluation

about 8 hours ago

Medicines for human use under evaluation

Start of procedure: Extension of marketing authorisation (24 July 2026 - 20 August 2026)

about 8 hours ago

Start of procedure: Extension of marketing authorisation (24 July 2026 - 20...

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (24 July 2026 - 20 August 2026)

about 8 hours ago

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