EMEA-003225-PIP01-22 - paediatric investigation plan

tinlarebant

Key facts

• Active substance:
  tinlarebant
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0060/2024
• PIP number:
  EMEA-003225-PIP01-22
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of Stargardt 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:
  07/03/2024
• Compliance check done:
  No

Decision

P/0060/2024

Adopted Reference Number: EMA/81788/2024