VARENICLINE SANDOZ (Sandoz Pty Ltd)

Product name

VARENICLINE SANDOZ

Date registered

16 February 2021

Evaluation commenced

27 February 2020

Decision date

4 December 2020

Approval time

141 (255 working days)

Active ingredients

varenicline citrate

Registration type

New generic medicine

Indication

VARENICLINE SANDOZ (tablet) is indicated as an aid to smoking cessation in adults over the age of 18 years.

Registration process

First generic

First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine