Human medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 14, Status: Authorised

Medicines for human use under evaluation

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (26 June 2026 - 23 July 2026)

Start of procedure: Extension of marketing authorisation (26 June 2026 - 23 July 2026)

New leadership team appointments

Dates of 2027 SAWP meetings and submission deadlines Scientific advice, protocol assistance, qualification of biomarkers and parallel HTACG/EMA Joint Scientific Consultation requests

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 6-8 July 2026

Annex to letter of intent

Template - Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004

Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Date of authorisation: 22/05/2014, Revision: 16, Status: Authorised