APO-ATOMOXETINE CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Mevcut itibaren:

APOTEX INC

ATC kodu:

N06BA09

INN (International Adı):

ATOMOXETINE

Doz:

10MG

Farmasötik formu:

CAPSULE

Kompozisyon:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/1000

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2010-09-21

Ürün özellikleri

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