EMEA-002430-PIP01-18 - paediatric investigation plan

timrepigene emparvovec

Key facts

• Active substance:
  timrepigene emparvovec
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0085/2020
• PIP number:
  EMEA-002430-PIP01-18
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of choroideremia
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/03/2020
• Compliance check done:
  Ne

Decision

P/0085/2020: EMA decision of 20 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for timrepigene emparvovec (EMEA-002430-PIP01-18)

Adopted Reference Number: EMA/101166/2020