APO-ATOMOXETINE CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Disponible desde:

APOTEX INC

Código ATC:

N06BA09

Designación común internacional (DCI):

ATOMOXETINE

Dosis:

80MG

formulario farmacéutico:

CAPSULE

Composición:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 80MG

Vía de administración:

ORAL

Unidades en paquete:

30/100/1000

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2010-09-21

Ficha técnica

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
...............................................................