PMS-VARENICLINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

VARENICLINE (VARENICLINE TARTRATE)

Доступна з:

PHARMASCIENCE INC

Код атс:

N07BA03

ІПН (Міжнародна Ім'я):

VARENICLINE

Дозування:

1MG

Фармацевтична форма:

TABLET

Склад:

VARENICLINE (VARENICLINE TARTRATE) 1MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

11/100

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS AUTONOMIC DRUGS

Огляд продуктів:

Active ingredient group (AIG) number: 0152190002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-02-14

Характеристики продукта

PRODUCT MONOGRAPH
Pr
PMS-VARENICLINE
Varenicline Tartrate Tablets
0.5 mg and 1mg varenicline (as varenicline tartrate)
SMOKING-CESSATION AID
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
April 4, 2019
Submission Control No: 226074
_pms-VARENICLINE 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
..................................................................................................24
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................39
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
..........................................................................41
CLINICAL TRIALS
..........................................................................................................42
DETAILED PHARMACOLOGY
..