EMEA-001371-PIP02-21 - paediatric investigation plan

clazakizumab

Key facts

• Active substance:
  clazakizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0393/2022
• PIP number:
  EMEA-001371-PIP02-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Prevention and treatment of rejection of transplanted kidney
• 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:
  09/09/2022
• Compliance check done:
  No

Decision

P/0393/2022 : EMA decision of 9 September 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for clazakizumab (EMEA-001371-PIP02-21)

Adopted Reference Number: EMA/677940/2022