EMEA-000309-PIP09-21 - paediatric investigation plan

tocilizumab

Key facts

• Invented name:
  RoActemra
• Active Substance:
  tocilizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0354/2022
• PIP number:
  EMEA-000309-PIP09-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of systemic sclerosis
• 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:
  10/08/2022

Decision

P/0354/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tocilizumab (RoActemra) (EMEA-000309-PIP09-21)

AdoptedReference Number: EMA/676104/2022