EMEA-003325-PIP01-22 - paediatric investigation plan

izokibep

Key facts

• Active substance:
  izokibep
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0268/2023
• PIP number:
  EMEA-003325-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)
• 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:
  14/07/2023
• Compliance check done:
  No

Decision

P/0268/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for izokibep (EMEA-003325-PIP01-22)

Reference Number: EMA/285108/2023