RIVA-ATOMOXETINE CAPSULE

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Beszerezhető a:

LABORATOIRE RIVA INC.

ATC-kód:

N06BA09

INN (nemzetközi neve):

ATOMOXETINE

Adagolás:

25MG

Gyógyszerészeti forma:

CAPSULE

Összetétel:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 25MG

Az alkalmazás módja:

ORAL

db csomag:

30

Recept típusa:

Prescription

Terápiás terület:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0150434003; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2013-05-10

Termékjellemzők

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