MHRA-101093-PIP02-23

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

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