EMA/PE/0000232765
Submitted by Anonymous (not verified) on 3 June 2026 - 16:15
EMA/PE/0000232765
EMA/PE/0000232765
PSUSA/00010508/202509
Human medicines European public assessment report (EPAR): Ameluz, 5-aminolevulinic acid hydrochloride, Date of authorisation: 13/12/2011, Revision: 23, Status: Authorised
Human medicines European public assessment report (EPAR): Xeplion, paliperidone, Date of authorisation: 04/03/2011, Revision: 17, Status: Authorised
Human medicines European public assessment report (EPAR): Namuscla, Mexiletine, Date of authorisation: 18/12/2018, Revision: 9, Status: Authorised
Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline
Biltricide
Insuman Basal and Comb 25
Integrilin
Mimpara