EMEA-002559-PIP03-19 - paediatric investigation plan

anti-neonatal Fe receptor human monoclonal antibody {M281)

Key facts

• Active substance:
  anti-neonatal Fe receptor human monoclonal antibody {M281)
• Therapeutic area:
  Other
• Decision number:
  P/0363/2020
• PIP number:
  EMEA-002559-PIP03-19
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of autoimmune haemolytic aneamia
• 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:
  09/09/2020
• Compliance check done:
  No

Decision

P/0363/2020 : EMA decision of 9 September 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-neonatal Fc receptor human monoclonal antibody (M281) (EMEA-002559-PIP03-19)

Adopted Reference Number: EMA/430125/2020