EMEA-001045-PIP02-18 - paediatric investigation plan

sarilumab

Key facts

• Invented name:
  • Kevzara
  • Kevzara
• Active Substance:
  sarilumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0335/2018
• PIP number:
  EMEA-001045-PIP02-18
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of vasculitides
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Sanofi-aventis recherche et développement

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/10/2018

Decision

P/0335/2018: EMA decision of 8 October 2018 on the granting of a product specific waiver for sarilumab (Kevzara), (EMEA-001045-PIP02-18)

AdoptedReference Number: EMA/578244/2018