EMEA-000309-PIP04-17-M03 - paediatric investigation plan

tocilizumab

Key facts

• Invented name:
  RoActemra
• Active Substance:
  tocilizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0303/2021
• PIP number:
  EMEA-000309-PIP04-17-M03
• Pharmaceutical form(s):
  • Solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of cytokine release syndrome associated with chimeric antigen receptor (CAR) T cell therapy or T-cell-engaging bispecific antibody therapy
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Contact for public enquiries:

  Roche Registration GmbH

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/08/2021

Decision

P/0303/2021 : EMA decision of 13 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tocilizumab (RoActemra) (EMEA-000309-PIP04-17-M03)

AdoptedReference Number: EMA/395845/2021