EMEA-001716-PIP05-20 - paediatric investigation plan

venglustat

Key facts

• Active substance:
  venglustat
• Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Uro-nephrology
• Decision number:
  P/0505/2020
• PIP number:
  EMEA-001716-PIP05-20
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of autosomal dominant polycystic kidney 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:
  22/12/2020
• Compliance check done:
  No

Decision

P/0505/2020 : EMA decision of 22 December 2020 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-PIP05-20)

Adopted Reference Number: EMA/632794/2020