MHRA-100123-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • SARILUMAB
Invented Name
  • Kevzara
  • Kevzara
PIP Number MHRA-100123-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
25/01/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100123-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SARILUMAB.pdf
Published Date 30/01/2024