EMEA-000309-PIP07-21 - paediatric investigation plan

tocilizumab

Key facts

• Invented name:
  RoActemra
• Active Substance:
  tocilizumab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0333/2021
• PIP number:
  EMEA-000309-PIP07-21
• 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
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/07/2021

Decision

P/0333/2021: EMA decision of 27 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for tocilizumab (RoActemra), (EMEA-000309-PIP07-21)

AdoptedReference Number: EMA/421854/2021