EMEA-003374-PIP01-22 - paediatric investigation plan

Adeno-associated viral vector serotype 9 expressing codon-optimized human GRN gene (LY3884963)

Key facts

• Active Substance:
  Adeno-associated viral vector serotype 9 expressing codon-optimized human GRN gene (LY3884963)
• Therapeutic area:
  Neurology
• Decision number:
  P/0188/2023
• PIP number:
  EMEA-003374-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of frontotemporal dementia
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2023

Decision

P/0188/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for adeno-associated viral vector serotype 9 expressing codon-optimized human GRN gene (LY3884963) (EMEA-003374-PIP01-22)

Reference Number: EMA/198966/2023