TEVA-ATOMOXETINE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

N06BA09

DCI (Dénomination commune internationale):

ATOMOXETINE

Dosage:

80MG

forme pharmaceutique:

CAPSULE

Composition:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 80MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0150434006; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2011-02-03

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
TEVA-ATOMOXETINE
(atomoxetine capsules)
10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
atomoxetine (as atomoxetine hydrochloride)
Teva Standard
Selective Norepinephrine Reuptake Inhibitor
for Attention-Deficit/Hyperactivity Disorder (ADHD)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No: 227394
Date of Revision:
July 2, 2019
_TEVA-ATOMOXETINE Page 2 of 64_
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
....................................................................................
24
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
......................................