EMEA-002842-PIP01-20 - paediatric investigation plan

Iscalimab

Key facts

• Active Substance:
  Iscalimab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0222/2021
• PIP number:
  EMEA-002842-PIP01-20
• Pharmaceutical form(s):
  • Solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Prophylaxis of solid organ transplant rejection
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/06/2021

Decision

P/0222/2021 : EMA decision of 8 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for iscalimab (EMEA-002842-PIP01-20)

AdoptedReference Number: EMA/301778/2021