EMEA-002189-PIP04-20 - paediatric investigation plan

bimekizumab

Key facts

• Active substance:
  bimekizumab
• Therapeutic area:
  • Dermatology
  • Immunology-Rheumatology-Transplantation
• Decision number:
  P/0078/2021
• PIP number:
  EMEA-002189-PIP04-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hidradenitis suppurativa
• 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:
  17/03/2021
• Compliance check done:
  No
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0078/2021: EMA desicion of 17 March 2021 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-PIP04-20)

Adopted Reference Number: EMA/71529/2021