EMEA-002681-PIP03-21 - paediatric investigation plan

Rozanolixizumab

Key facts

• Active Substance:
  Rozanolixizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0420/2023
• PIP number:
  EMEA-002681-PIP03-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease
• 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:
  27/10/2023

Decision

P/0420/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rozanolixizumab (EMEA-002681-PIP03-21)

AdoptedReference Number: EMA/421682/2023