EMEA-003238-PIP01-22 - paediatric investigation plan

Pozelimab

Key facts

• Active Substance:
  Pozelimab
• Therapeutic area:
  Neurology
• Decision number:
  P/0077/2023
• PIP number:
  EMEA-003238-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Regeneron Ireland DAC

  E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/03/2023

Decision

P/0077/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pozelimab (EMEA-003238-PIP01-22)

Reference Number: EMA/74611/2023