EMEA-002033-PIP01-16-M03 - paediatric investigation plan

Vosoritide

Key facts

• Invented name:
  Voxzogo
• Active Substance:
  Vosoritide
• Therapeutic area:
  Other
• Decision number:
  P/0453/2022
• PIP number:
  EMEA-002033-PIP01-16-M03
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of achondroplasia
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  BioMarin International Limited

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/10/2022

Decision

P/0453/2022 : EMA decision of 24 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vosoritide (Voxzogo), (EMEA-002033-PIP01-16-M03)

AdoptedReference Number: EMA/834945/2022