EMEA-000309-PIP07-21-M01 - paediatric investigation plan

tocilizumab

Key facts

• Invented name:
  RoActemra
• Active substance:
  tocilizumab
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0028/2024
• PIP number:
  EMEA-000309-PIP07-21-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2024
• Compliance check done:
  Не

Decision

P/0028/2024 : EMA decision of 29 January 2024 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a product-specific waiver for tocilizumab (RoActemra), (EMEA-000309-PIP07-21-M01)

Adopted Reference Number: EMA/29054/2024