EMEA-002338-PIP04-23 - paediatric investigation plan

Ianalumab

Key facts

• Active Substance:
  Ianalumab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0075/2024
• PIP number:
  EMEA-002338-PIP04-23
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of autoimmune haemolytic anaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/03/2024

Decision

P/0075/2024 : EMA decision of 8 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ianalumab (EMEA-002338-PIP04-23)

AdoptedReference Number: EMA/89916/2024