TZIELD (Sanofi-Aventis Australia Pty Ltd)
Product name
TZIELD
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
218 (255 working days)
Active ingredients
teplizumab
Registration type
NCE/NBE
Indication
Tzield is indicated to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus (see Section 5.1 Pharmacodynamic Properties - Clinical trials).