APO-ATOMOXETINE CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Tilgjengelig fra:

APOTEX INC

ATC-kode:

N06BA09

INN (International Name):

ATOMOXETINE

Dosering :

10MG

Legemiddelform:

CAPSULE

Sammensetning:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 10MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100/1000

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0150434001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2010-09-21

Preparatomtale

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