EMEA-003365-PIP02-23 - paediatric investigation plan

govorestat

Key facts

• Active substance:
  govorestat
• Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Neurology
• Decision number:
  P/0487/2023
• PIP number:
  EMEA-003365-PIP02-23
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of galactosaemia
• 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:
  30/11/2023
• Compliance check done:
  No

Decision

P/0487/2023: EMA decision of 30 November 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for govorestat (EMEA-003365-PIP02-23)

Adopted Reference Number: EMA/530837/2023