Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • anti-CD40L humanized monoclonal antibody (SAR441344)
Invented Name
Not yet available
PIP Number MHRA-100135-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of Sjogren's Syndrome
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
PIP applicant
  • sanofi-aventis recherche & d√©veloppement
  • Country France
  • Tel +330169745695
  • Email
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):anti-CD40L humanized monoclonal antibody (SAR441344).pdf
Published Date 17/05/2022