EMEA-002033-PIP02-23 - paediatric investigation plan

vosoritide

Key facts

• Invented name:
  Voxzogo
• Active substance:
  vosoritide
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0286/2024
• PIP number:
  EMEA-002033-PIP02-23
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of ataxia telangiectasia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0286/2024: EMA decision of 16 August 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for vosoritide (Voxzogo), (EMEA-002033-PIP02-23)

Adopted Reference Number: EMA/344245/2024