APO-ATOMOXETINE CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Предлага се от:

APOTEX INC

АТС код:

N06BA09

INN (Международно Name):

ATOMOXETINE

дозиране:

18MG

Лекарствена форма:

CAPSULE

Композиция:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 18MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100/1000

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0150434002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2010-09-21

Данни за продукта

Page 1 of 60
PRODUCT MONOGRAPH
PR
APO-ATOMOXETINE
ATOMOXETINE HYDROCHLORIDE CAPSULES
10 MG, 18 MG, 25 MG, 40 MG, 60 MG, 80 MG AND 100 MG*
*ATOMOXETINE AS ATOMOXETINE HYDROCHLORIDE
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
DATE OF REVISION:
January 8, 2016
SUBMISSION CONTROL NO: 190898
Page 2 of 60
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
.......................................................................
3
CONTRAINDICATIONS
.............................................................................................
4
WARNINGS AND PRECAUTIONS
...........................................................................
5
ADVERSE REACTIONS
.............................................................................................
13
DRUG ABUSE AND DEPENDENCE
.........................................................................
23
DRUG INTERACTIONS
............................................................................................
24
DOSAGE AND ADMINISTRATION
........................................................................
26
OVERDOSAGE
............................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 30
STORAGE AND STABILITY
.....................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 35
PART II: SCIENTIFIC INFORMATION
............................................................... 37
PHARMACEUTICAL INFORMATION
.....................................................................
37
CLINICAL TRIALS
...............................................................