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CHAMPIX DIN 02291177

Status: Cancelled Post Market
Holder: PFIZER CANADA ULC
Molecule: VARENICLINE (VARENICLINE TARTRATE)
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Health Canada record

Active ingredient(s)VARENICLINE (VARENICLINE TARTRATE) 0.5 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCN07BA03 VARENICLINE
Original market date11-Apr-2007
Current status date10-Apr-2024
SourceHealth Canada DPD

Establishment licence of the holder

Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing VARENICLINE (VARENICLINE TARTRATE)

DINProductCompanyFormStrengthStatus
02419890APO-VARENICLINEAPOTEX INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02435675APO-VARENICLINEAPOTEX INCKit; TabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02419882APO-VARENICLINEAPOTEX INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02554445AURO-VARENICLINEAURO PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02554453AURO-VARENICLINEAURO PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02546957MINT-VARENICLINEMINT PHARMACEUTICALS INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02546965MINT-VARENICLINEMINT PHARMACEUTICALS INCKit; TabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02546949MINT-VARENICLINEMINT PHARMACEUTICALS INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02542986NRA-VARENICLINENORA PHARMA INCTablet; KitVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02542951NRA-VARENICLINENORA PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02542978NRA-VARENICLINENORA PHARMA INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02559900ZDS-VARENICLINEZYDUS LIFESCIENCES LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGMarketed
02559897ZDS-VARENICLINEZYDUS LIFESCIENCES LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGMarketed
02291185CHAMPIXPFIZER CANADA ULCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Post Market
02298309CHAMPIXPFIZER CANADA ULCTablet; KitVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Post Market
02438445GD-VARENICLINEGENMED A DIVISION OF PFIZER CANADA ULCKit; TabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02438437GD-VARENICLINEGENMED A DIVISION OF PFIZER CANADA ULCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02438429GD-VARENICLINEGENMED A DIVISION OF PFIZER CANADA ULCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGCancelled Pre Market
02485869PMS-VARENICLINEPHARMASCIENCE INCKit; TabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02458519PMS-VARENICLINEPHARMASCIENCE INCTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Pre Market
02458500PMS-VARENICLINEPHARMASCIENCE INCTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGCancelled Pre Market
02426781TEVA-VARENICLINETEVA CANADA LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MG; VARENICLINE (VARENICLINE TARTRATE) 1 MGCancelled Post Market
02426234TEVA-VARENICLINETEVA CANADA LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 1 MGDormant
02426226TEVA-VARENICLINETEVA CANADA LIMITEDTabletVARENICLINE (VARENICLINE TARTRATE) 0.5 MGDormant

Notices of Compliance

NOCDateSubmissionReason
163272014-11-20Supplement to a New Drug Submission (SNDS)DESCRIPTION OF TWO NEW STUDIES IN THE ACTION AND CLINICAL PHARMACOLOGY SECTION OF THE PRODUCT MONOGRAPH
85572007-01-24New Drug Submission (NDS)
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