EMEA-003208-PIP02-22 - paediatric investigation plan

Itolizumab

Key facts

• Active Substance:
  Itolizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0178/2023
• PIP number:
  EMEA-003208-PIP02-22
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute graft versus host disease
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Biocon Pharma Malta-I Limited; E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/05/2023

Decision

P/0178/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for itolizumab (EMEA-003208-PIP02-22)

AdoptedReference Number: EMA/171157/2023