EMEA-002189-PIP03-19 - paediatric investigation plan

bimekizumab

Key facts

• Active substance:
  bimekizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0456/2020
• PIP number:
  EMEA-002189-PIP03-19
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis 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:
  01/12/2020
• Compliance check done:
  No

Decision

P/0456/2020: EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bimekizumab (EMEA-002189-PIP03-19)

Reference Number: EMA/621046/2020 Corr