EMEA-002338-PIP01-18 - paediatric investigation plan

Ianalumab

Key facts

• Active substance:
  Ianalumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0041/2019
• PIP number:
  EMEA-002338-PIP01-18
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of autoimmune hepatitis
• 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:
  29/01/2019
• Compliance check done:
  No

Decision

P/0041/2019: EMA decision of 29 January 2019 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-PIP01-18)

Adopted Reference Number: EMA/887308/2018