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
• Contact for public enquiries:

  CSL Behring GmbH

  email: [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:
  09/09/2022

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)

AdoptedReference Number: EMA/677940/2022