EMEA-001716-PIP04-19-M01 - paediatric investigation plan

venglustat

Key facts

• Active substance:
  venglustat
• Therapeutic area:
  Endrocrine disorders
• Decision number:
  P/0529/2023
• PIP number:
  EMEA-001716-PIP04-19-M01
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of galactosialidosis
  • Treatment of GM1 gangliosidosis
  • Treatment of GM2 gangliosidosis
  • Treatment of sialidosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0529/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for venglustat (EMEA- 001716-PIP04-19-M01)

Reference Number: EMA/513173/2023