PAROXETINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Предлага се от:

COBALT PHARMACEUTICALS COMPANY

АТС код:

N06AB05

INN (Международно Name):

PAROXETINE

дозиране:

20MG

Лекарствена форма:

TABLET

Композиция:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 20MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0123131002; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2017-09-01

Данни за продукта

PRODUCT MONOGRAPH
Pr
PAROXETINE
Paroxetine Tablets USP
10 mg, 20 mg, 30 mg paroxetine as Paroxetine hydrochloride
Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent
–
Social Phobia (Social Anxiety Disorder) – Posttraumatic Stress
Disorder Therapy
Manufactured by:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Rd.
Mississauga, Ontario
L5N 2B8
Date of Preparation:
January 25, 2010
Submission Control No.: 135928
-2-
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION . . . . . . . . . . . . . . .
. . . . . . . . . . . . . 3
SUMMARY PRODUCT INFORMATION . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 3
INDICATIONS AND CLINICAL USE . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 3
CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 5
WARNINGS AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 6
ADVERSE REACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 13
DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 24
DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . 28
OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 31
ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 32
STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 35
DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . .
. . . . . . . 35
PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 37
PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 37
CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . .