EMEA-001716-PIP07-22-M01 - paediatric investigation plan

venglustat

Key facts

• Active substance:
  venglustat
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0172/2024
• PIP number:
  EMEA-001716-PIP07-22-M01
• Pharmaceutical form(s):
  Chewable tablet
• Condition(s) / indication(s):
  • Treatment of Gaucher disease, type 2
  • Treatment of Gaucher disease, type 3
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/05/2024
• Compliance check done:
  No

Decision

P/0172/2024: EMA decision of 3 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for venglustat (EMEA- 001716-PIP07-22-M01)

Adopted Reference Number: EMA/182551/2024