PMS-ATOMOXETINE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

N06BA09

DCI (Dénomination commune internationale):

ATOMOXETINE

Dosage:

100MG

forme pharmaceutique:

CAPSULE

Composition:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 100MG

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: 0150434007; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2013-04-12

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
PMS-ATOMOXETINE
(ATOMOXETINE 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)
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave., Suite 100
February 08, 2016
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No: 191655
_ _
_pms-ATOMOXETINE Product Monograph _
_Page 2 of 58_
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
.....................................................................................................
12
DRUG ABUSE AND DEPENDENCE
................................................................................
24
DRUG INTERACTIONS
.....................................................................................................
24
DOSAGE AND ADMINISTRATION
.................................................................................
26
OVERDOSAGE
...................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 30
STORAGE AND STABILITY
.............................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 35
PART II: SCIENTIFIC INFORMATION
...................................................................