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Agenda of the Medicine Shortages SPOC Working Party meeting - 11 September 2024

Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)

Agenda - Information session on the pilot for expert panels' advice for orphan medical devices

Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP

Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)

Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use

Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP

Human medicines European public assessment report (EPAR): Tadalafil Lilly, tadalafil, Date of authorisation: 22/03/2017, Revision: 7, Status: Authorised

Questions and answers regarding co-processed excipients used in solid oral dosage forms