EMEA-002945-PIP01-20 - paediatric investigation plan

anti-CD40L humanized monoclonal antibody (SAR441344)

Key facts

• Active substance:
  anti-CD40L humanized monoclonal antibody (SAR441344)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0200/2021
• PIP number:
  EMEA-002945-PIP01-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Sjögren's syndrome
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/05/2021
• Compliance check done:
  Ne

Decision

P/0200/2021 : EMA decision of 10 May 2021 on the granting of a product specific waiver for anti-CD40L humanized monoclonal antibody (SAR441344) (EMEA-002945-PIP01-20)

Adopted Reference Number: EMA/251427/2021