MHRA-100918-PIP01-23

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

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