EMEA-002427-PIP01-18-M02 - paediatric investigation plan

valoctocogene roxaparvovec

Key facts

• Active substance:
  valoctocogene roxaparvovec
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0156/2023
• PIP number:
  EMEA-002427-PIP01-18-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:
  12/05/2023
• Compliance check done:
  No

Decision

P/0156/2023: EMA decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for valoctocogene roxaparvovec (Roctavian), (EMEA-002427-PIP01-18-M02)

Reference Number: EMA/170273/2023