EMEA-000439-PIP03-23 - paediatric investigation plan

bitopertin

Key facts

• Active substance:
  bitopertin
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0352/2024
• PIP number:
  EMEA-000439-PIP03-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate dosage form
• Condition(s) / indication(s):
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0352/2024: EMA decision of 25 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bitopertin (EMEA-000439-PIP03-23)

Adopted Reference Number: EMA/442341/2024