GD-VARENICLINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-10-2018
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Active ingredient:
VARENICLINE (VARENICLINE TARTRATE)
Available from:
GENMED A DIVISION OF PFIZER CANADA ULC
ATC code:
N07BA03
INN (International Name):
VARENICLINE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
VARENICLINE (VARENICLINE TARTRATE) 1MG
Administration route:
ORAL
Units in package:
11/14/28/56
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS AUTONOMIC DRUGS
Product summary:
Active ingredient group (AIG) number: 0152190002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2019-03-06
Summary of Product characteristics
_GD-Varenicline (varenicline tartrate) - Product Monograph _
_Page 1 of 61_
PRODUCT MONOGRAPH
Pr
GD
®
-VARENICLINE
(varenicline tartrate tablets)
0.5 mg and 1.0 mg varenicline (as varenicline tartrate)
Smoking-Cessation Aid
GenMed, a division of Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
® GD
is a trademark of Pfizer Canada Inc.
GenMed, a division of
Pfizer Canada Inc., Licensee
© 2018 Pfizer Canada Inc.
Date of Revision:
October 16, 2018
Submission Control No: 219175
_GD-Varenicline (varenicline tartrate) - Product Monograph _
_Page 2 of 61_
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
..................................................................................................25
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................41
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................41
PART II: SCIENTIFIC INFORMATION
...............................................................................42
PHARMACEUTICAL INFORMATION
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