EMEA-003502-PIP01-23 - paediatric investigation plan

mezagitamab

Key facts

• Active substance:
  mezagitamab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0292/2024
• PIP number:
  EMEA-003502-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of immune thrombocytopenia
• 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/0292/2024: EMA decision of 16 August 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mezagitamab (EMEA-003502-PIP01-23)

Adopted Reference Number: EMA/343392/2024