EMEA-000309-PIP02-14 - paediatric investigation plan

tocilizumab

Key facts

• Invented name:
  • RoActemra
  • RoActemra
• Active substance:
  tocilizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0135/2015
• PIP number:
  EMEA-000309-PIP02-14
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of vasculitides
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/06/2015
• Compliance check done:
  No

Decision

P/0135/2015: EMA decision of 15 June 2015 on the granting of a product-specific waiver for tocilizumab (RoActemra), (EMEA-000309-PIP02-14)

Adopted Reference Number: EMA/368601/2015