Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
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
Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)
Human medicines European public assessment report (EPAR): Cialis, tadalafil, Date of authorisation: 12/11/2002, Revision: 33, Status: Authorised