EMEA-003162-PIP01-21 - paediatric investigation plan

batoclimab

Key facts

• Active Substance:
  batoclimab
• Therapeutic area:
  Neurology
• Decision number:
  P/0473/2022
• PIP number:
  EMEA-003162-PIP01-21
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• 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:
  01/12/2022

Decision

P/0473/2022: EMA decision of 1 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for batoclimab (EMEA-003162-PIP01-21)

AdoptedReference Number: EMA/897971/2022