CHAMPIX TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

VARENICLINE (VARENICLINE TARTRATE)

Mevcut itibaren:

PFIZER CANADA ULC

ATC kodu:

N07BA03

INN (International Adı):

VARENICLINE

Doz:

0.5MG

Farmasötik formu:

TABLET

Kompozisyon:

VARENICLINE (VARENICLINE TARTRATE) 0.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

11/56

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS AUTONOMIC DRUGS

Ürün özeti:

Active ingredient group (AIG) number: 0152190001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2014-11-20

Ürün özellikleri

_CHAMPIX (varenicline tartrate) - Product Monograph _
_Page 1 of 60 _
_ _
PRODUCT MONOGRAPH
Pr
CHAMPIX
®
(varenicline tartrate tablets)
0.5 mg and 1.0 mg varenicline (as varenicline tartrate)
Smoking-Cessation Aid
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
® C.P. Pharmaceuticals International C.V.
Pfizer Canada Inc., licensee
© 2019 Pfizer Canada ULC
Date of Revision:
January 22, 2019
Submission Control No: 221214
_CHAMPIX (varenicline tartrate) - Product Monograph _
_Page 2 of 60 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................24
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
INDICATIONS AND CLINICAL USE
............................................................................32
STORAGE AND STABILITY
..........................................................................................40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................40
PART II: SCIENTIFIC INFORMATION
..........................................................