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

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
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
  • sanofi-aventis recherche et d√©veloppement
  • Country France
  • Tel +33169745695
  • Email
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

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