TEPEZZA (Amgen Australia Pty Ltd)
Product name
TEPEZZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
151 (255 working days)
Active ingredients
teprotumumab
Registration type
NCE/ NBE
Indication
TEPEZZA is indicated for the treatment of moderate to severe Thyroid Eye Disease (TED) (see section 5.1 Pharmacodynamic properties – Clinical trials).