RIVA-ATOMOXETINE CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Disponible des:

LABORATOIRE RIVA INC.

Codi ATC:

N06BA09

Designació comuna internacional (DCI):

ATOMOXETINE

Dosis:

18MG

formulario farmacéutico:

CAPSULE

Composición:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 18MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2013-05-10

Fitxa tècnica

PRODUCT MONOGRAPH
PR RIVA-ATOMOXETINE
(Atomoxetine Capsules)
10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg atomoxetine
(as atomoxetine hydrochloride)
Professed Standard
Selective Norepinephrine Reuptake Inhibitor
for Attention-Deficit/Hyperactivity Disorder (ADHD)
LABORATOIRE RIVA INC.
660 Industriel Blvd.
Blainville, Quebec, Canada.
J7C 3V4
www.labriva.com
Date of Revision: June 22, 2016
Submission Control No: 195326
_ _
_Product Monograph - RIVA-ATOMOXETINE _
_Page 2 of 49_
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
................................................................................................11
DRUG ABUSE AND DEPENDENCE
...........................................................................19
DRUG INTERACTIONS
................................................................................................19
DOSAGE AND ADMINISTRATION
...........................................................................21
OVERDOSAGE
...............................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
........................................................25
STORAGE AND
STABILITY........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................29
PART II: SCIENTIFIC INFORMATION
................................................................................30
PHARMACEUTICAL INFORMATION
....................