EMEA-002945-PIP02-21 - paediatric investigation plan

Anti-CD40L humanized monoclonal antibody (SAR441344)

Key facts

• Active Substance:
  Anti-CD40L humanized monoclonal antibody (SAR441344)
• Therapeutic area:
  Neurology
• Decision number:
  P/0167/2022
• PIP number:
  EMEA-002945-PIP02-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of progressive multiple sclerosis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Contact for public enquiries:

  Sanofi Winthrop Industrie

  Email: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2022

Decision

P/0167/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for anti-CD40L humanised monoclonal antibody (SAR441344) (EMEA-002945-PIP02-21)

AdoptedReference Number: EMA/204558/2022