MHRA-100135-PIP02-22

Key Facts

Active Substance
Active Substance:
  • anti-CD40L humanised monoclonal antibody (SAR441344)
Invented Name
Not yet available
PIP Number MHRA-100135-PIP02-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of progressive Multiple Sclerosis
Route(s) of administration
  • Intravenous use
  • SUBCUTANEOUS USE
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):anti-CD40L humanised monoclonal antibody (SAR441344).pdf
Published Date 07/12/2022