EMA/PE/0000243861 - paediatric investigation plan

venglustat

Key facts

• Active substance:
  venglustat
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000243861
• PIP number:
  EMA/PE/0000243861
• 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:
  Nu

Decision

EMA/PE/0000243861 : EMA decision of 12 June 2025 on the refusal of a modification of an agreed paediatric investigation plan for venglustat (Infilbray)

Adopted Reference Number: EMADOC-1700519818-2183594