EMEA-000309-PIP06-21 - paediatric investigation plan

tocilizumab

Key facts

• Invented name:
  RoActemra
• Active Substance:
  tocilizumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0466/2021
• PIP number:
  EMEA-000309-PIP06-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of systemic sclerosis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  29/10/2021

Decision

P/0466/2021: EMA decision of 29 October 2021 on the refusal of a product specific waiver for tocilizumab (RoActemra), (EMEA-000309-PIP06-21)

AdoptedReference Number: EMA/535247/2021