MHRA-101093-PIP02-23

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • satralizumab
Invented Name
  • Enspryng
  • Enspryng
  • Enspryng
PIP Number MHRA-101093-PIP02-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
  • Neurology
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment for thyroid eye disease (TED)
Route(s) of administration
Route(s) of administration:
  • 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

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