EMEA-003290-PIP01-22 - paediatric investigation plan

dirloctocogene samoparvovec

Key facts

• Active substance:
  dirloctocogene samoparvovec
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0306/2023
• PIP number:
  EMEA-003290-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of moderate or severe haemophilia A without Factor VIII inhibitors
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2023
• Compliance check done:
  No

Decision

P/0306/2023 : EMA decision of 11 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for dirloctocogene samoparvovec, (EMEA-003290-PIP01-22)

Reference Number: EMA/336633/2023