EMEA-003027-PIP02-23 - paediatric investigation plan

sepiapterin

Key facts

• Active Substance:
  sepiapterin
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0041/2024
• PIP number:
  EMEA-003027-PIP02-23
• Pharmaceutical form(s):
  Oral powder
• Condition(s) / indication(s):
  Treatment of hyperphenylalaninaemia
• 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:
  02/02/2024

Decision

P/0041/2024 : EMA decision of 2 February 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for sepiapterin (EMEA-003027-PIP02-23)

AdoptedReference Number: EMA/50045/2024