MHRA-101230-PIP01-23

Key Facts

Active Substance
Active Substance:
  • teprotumumab
Invented Name
  • Not available at present
  • TEPEZZA
PIP Number MHRA-101230-PIP01-23
Pharmaceutical form(s)
  • Powder for concentrate for solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of thyroid eye disease
Route(s) of administration
  • Intravenous use
  • 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):teprotumumab.pdf
Published Date 30/04/2024