MHRA-100918-PIP01-23

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • BELIMUMAB
Invented Name
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
PIP Number MHRA-100918-PIP01-23
Pharmaceutical form(s)
  • Solution for injection
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of systemic sclerosis
Route(s) of administration
  • Subcutaneous use
  • INTRAVENOUS USE
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BELIMUMAB.pdf
Published Date 24/06/2024