EMA/PE/0000232771 - paediatric investigation plan

tacrolimus

Key facts

• Active substance:
  tacrolimus
• Therapeutic area:
  Eye disorders
• Decision number:
  EMA/PE/0000232771
• PIP number:
  EMA/PE/0000232771
• Pharmaceutical form(s):
  Eye drops, suspension
• Condition(s) / indication(s):
  Treatment of vernal keratoconjunctivitis
• Route(s) of administration:
  Ocular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  21/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000232771 : EMA decision of 21 March 2025 on the agreement of a paediatric investigation plan and on the granting of a waiver for tacrolimus

Adopted Reference Number: EMADOC-1700519818-1979393