APO-ATOMOXETINE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Saadav alates:

APOTEX INC

ATC kood:

N06BA09

INN (Rahvusvaheline Nimetus):

ATOMOXETINE

Annus:

10MG

Ravimvorm:

CAPSULE

Koostis:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/100/1000

Retsepti tüüp:

Prescription

Terapeutiline ala:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2010-09-21

Toote omadused

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