EMEA-003459-PIP01-23 - paediatric investigation plan

recombinant adeno-associated virus Olig001 containing human aspartoacylase cDNA

Key facts

• Active substance:
  recombinant adeno-associated virus Olig001 containing human aspartoacylase cDNA
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0214/2024
• PIP number:
  EMEA-003459-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Canavan disease
• Route(s) of administration:
  Intracerebral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/06/2024
• Compliance check done:
  No

Decision

P/0214/2024 : EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the refusal of a deferral for recombinant adeno-associated virus Olig001 containing human aspartoacylase cDNA (MYR-101), (EMEA-003459- PIP01-23)

Adopted Reference Number: EMA/255060/2024