EMEA-003168-PIP01-21 - paediatric investigation plan

sirolimus

Key facts

• Active substance:
  sirolimus
• Therapeutic area:
  Dermatology
• Decision number:
  P/0480/2022
• PIP number:
  EMEA-003168-PIP01-21
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of tuberous sclerosis complex
• Route(s) of administration:
  Cutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/12/2022
• Compliance check done:
  Nu

Decision

P/0480/2022: EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sirolimus (EMEA-003168-PIP01-21)

Adopted Reference Number: EMA/899045/2022