EMEA-001416-PIP01-12-M03 - paediatric investigation plan

sirolimus

Key facts

• Active substance:
  sirolimus
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0336/2021
• PIP number:
  EMEA-001416-PIP01-12-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic non-infectious uveitis
• Route(s) of administration:
  Intravitreal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2021
• Compliance check done:
  Nie

Decision

P/0336/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sirolimus (EMEA-001416-PIP01-12-M03)

Adopted Reference Number: EMA/434139/2021