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VARENICLINE SANDOZ (Sandoz Pty Ltd)
Product name
VARENICLINE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
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