GLICLAZIDE GH MR,GLICLAZIDE LAPL MR ,GLICLAZIDE LUPIN MR (Lupin Australia Pty Limited)
Product name
GLICLAZIDE GH MR,GLICLAZIDE LAPL MR ,GLICLAZIDE LUPIN MR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
136 (255 working days)
Active ingredients
Gliclazide
Registration type
New generic medicine
Indication
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.