EMEA-000309-PIP01-08-M07 - paediatric investigation plan

tocilizumab

Key facts

• Invented name:
  • RoActemra
  • RoActemra
• Active substance:
  tocilizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0266/2015
• PIP number:
  EMEA-000309-PIP01-08-M07
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/11/2015
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000309-PIP01-08-M07
• Compliance opinion date:
  23/02/2018
• Compliance outcome:
  Positive

Decision

P/0266/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tocilizumab (RoActemra) (EMEA-000309-PIP01-08-M07)

Adopted Reference Number: EMA/766676/2015