Translarna
ataluren
Muscular Dystrophy, Duchenne
Date of authorisation:
Revision: 23
Last updated:
MedicineHumanAuthorised
Agamree
Vamorolone
Muscular Dystrophy, Duchenne
Date of authorisation:
Last updated:
MedicineHumanAuthorised
EMEA-000115-PIP01-07-M12 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: P/0195/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Granules for oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Puldysa
idebenone
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
Exondys
eteplirsen
Muscular Dystrophy, Duchenne
Date of refusal:
Last updated:
MedicineHumanRefused
EMEA-000115-PIP02-09-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0284/2016
Route(s) of administration: Oral use
Pharmaceutical form(s):
Granules for oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Kyndrisa
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application