EMEA-001071-PIP02-12-M02 - paediatric investigation plan

certolizumab pegol

Key facts

• Invented name:
  • Cimzia
  • Cimzia
• Active substance:
  certolizumab pegol
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0192/2017
• PIP number:
  EMEA-001071-PIP02-12-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/07/2017
• Compliance check done:
  Não

Decision

P/0192/2017: EMA decision of 3 July 2017 on the refusal of a modification of an agreed paediatric investigation plan for certolizumab pegol (Cimzia), (EMEA-001071-PIP02-12-M02)

Adopted Reference Number: EMA/348026/2017