EMEA-002724-PIP01-19-M02 - paediatric investigation plan

Giroctocogene fitelparvovec

Key facts

• Active Substance:
  Giroctocogene fitelparvovec
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0555/2021
• PIP number:
  EMEA-002724-PIP01-19-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Haemophilia A
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/01/2022

Decision

P/0555/2021: EMA decision of 4 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for giroctocogene fitelparvovec, (EMEA-002724-PIP01-19-M02)

AdoptedReference Number: EMA/709767/2021