Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
Invented Name
Not yet available
PIP Number MHRA-100556-PIP01-22
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection in pre-filled pen
  • Solution for infusion
Therapeutic area
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
Route(s) of administration
  • intravenous
  • 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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Anti-C1s Humanized IgG4 Monoclonal Antibody.pdf
Published Date 07/12/2022