AG-ATOMOXETINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Tersedia dari:

ANGITA PHARMA INC.

Kode ATC:

N06BA09

INN (Nama Internasional):

ATOMOXETINE

Dosis:

40MG

Bentuk farmasi:

CAPSULE

Komposisi:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 40MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0150434004; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-11-30

Karakteristik produk

AG-ATOMOXETINE Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
AG-ATOMOXETINE
Atomoxetine Capsules
10, 18, 25, 40, 60, 80 and 100 mg atomoxetine (as atomoxetine
hydrochloride)
House standard
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Date of Revision:
November 26, 2020
Submission Control No. 245703
AG-ATOMOXETINE Product Monograph
Page 2
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
.................................................................................................
12
DRUG ABUSE AND DEPENDENCE
............................................................................
22
DRUG INTERACTIONS
..................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
.................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 33
PART II: SCIENTIFIC INFORMATION
............................................................................
34
PHARMACEUTICAL INFORMATION
........................