RATIO-ATOMOXETINE CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

N06BA09

INN (International Name):

ATOMOXETINE

Dosering :

18MG

Legemiddelform:

CAPSULE

Sammensetning:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 18MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100/500

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2015-10-16

Preparatomtale

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PRODUCT MONOGRAPH
PR
RATIO-ATOMOXETINE
Atomoxetine Hydrochloride Capsules
10mg, 18mg, 25mg, 40mg and 60mg atomoxetine (as atomoxetine
hydrochloride)
Selective Norepinephrine Reuptake Inhibitor for
Attention-Deficit/Hyperactivity
Disorder (ADHD)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision :
May 31, 2012
SUBMISSION CONTROL NO.: 153586
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................. 3
INDICATIONS AND CLINICAL USE
.................................................................... 3
Special Diagnostic Considerations
............................................................................
3
Need for Comprehensive Treatment Program
........................................................... 4
CONTRAINDICATIONS
.........................................................................................
4
WARNINGS AND PRECAUTIONS
........................................................................
5
ADVERSE REACTIONS
........................................................................................
12
DRUG ABUSE AND DEPENDENCE
................................................................... 21
DRUG INTERACTIONS
........................................................................................
22
DOSAGE AND ADMINISTRATION
....................................................................
24
OVERDOSAGE
......................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
.................................................. 27
STORAGE AND STABILITY
................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 32