EMEA-001371-PIP03-22 - paediatric investigation plan

clazakizumab

Key facts

• Active substance:
  clazakizumab
• Therapeutic area:
  • Cardiovascular diseases
  • Uro-nephrology
• Decision number:
  P/0099/2023
• PIP number:
  EMEA-001371-PIP03-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of cardiovascular events in patients with atherosclerosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2023
• Compliance check done:
  No

Decision

P/0099/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for clazakizumab, (EMEA-001371-PIP03-22)

Reference Number: EMA/65227/2023