GLICLAZIDE MR MYLAN (Alphapharm Pty Ltd)
Product name
GLICLAZIDE MR MYLAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
Gliclazide
Registration type
New generic medicine
Indication
Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.
During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.