EMEA-003167-PIP01-21 - paediatric investigation plan

Adeno-associated virus vector serotype 1 containing the human GRN gene

Key facts

• Active Substance:
  Adeno-associated virus vector serotype 1 containing the human GRN gene
• Therapeutic area:
  Neurology
• Decision number:
  P/0182/2022
• PIP number:
  EMEA-003167-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of frontotemporal dementia
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Passage Bio, Inc.

  Email: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2022

Decision

P/0182/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for adeno-associated virus vector serotype 1 containing the human GRN gene (EMEA-003167-PIP01-21)

AdoptedReference Number: EMA/207941/2022