APO-VARENICLINE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
18-12-2023
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Werkstoffen:
VARENICLINE (VARENICLINE TARTRATE)
Beschikbaar vanaf:
APOTEX INC
ATC-code:
N07BA03
INN (Algemene Internationale Benaming):
VARENICLINE
Dosering:
0.5MG
farmaceutische vorm:
TABLET
Samenstelling:
VARENICLINE (VARENICLINE TARTRATE) 0.5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
28/30/56/60/100
Prescription-type:
Prescription
Therapeutisch gebied:
MISCELLANEOUS AUTONOMIC DRUGS
Product samenvatting:
Active ingredient group (AIG) number: 0152190001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2018-02-02
Productkenmerken
_APO-VARENICLINE PRODUCT MONOGRAPH_
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_PAGE 1 OF 58 _
PRODUCT MONOGRAPH
PR
APO-VARENICLINE
VARENICLINE TARTRATE TABLETS
0.5 MG AND 1 MG VARENICLINE (AS VARENICLINE TARTRATE)
SMOKING-CESSATION AID
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
December 18, 2023
SUBMISSION CONTROL NUMBER: 275299
_APO-VARENICLINE PRODUCT MONOGRAPH_
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_PAGE 2 OF 58 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
12
DRUG INTERACTIONS
.......................................................................................................
24
DOSAGE AND ADMINISTRATION
...................................................................................
26
OVERDOSAGE
......................................................................................................................
29
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
30
STORAGE AND STABILITY
...............................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 39
PART II: SCIENTIFIC INFORMATION
..............................................................................
40
PHARMACEUTICAL INFORMATION
...............................................................................
40
CLINICAL TRIALS
.............................
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