EMEA-001716-PIP08-23 - paediatric investigation plan

venglustat

Key facts

• Active substance:
  venglustat
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0385/2024
• PIP number:
  EMEA-001716-PIP08-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of Fabry disease
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0385/2024: EMA decision of 25 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for venglustat (EMEA-001716-PIP08-23)

Adopted Reference Number: EMA/491310/2024