MYLAN-ATOMOXETINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

N06BA09

INN (Nama Internasional):

ATOMOXETINE

Dosis:

60MG

Bentuk farmasi:

CAPSULE

Komposisi:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 60MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0150434005; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-07-12

Karakteristik produk

MYLAN-ATOMOXETINE Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
MYLAN-ATOMOXETINE
(ATOMOXETINE CAPSULES, USP)
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)
MYLAN PHARMACEUTICALS ULC
Date of Revision:
85 Advance Rd.
January 7, 2016
Etobicoke, On, M8Z 2S6
Canada
SUBMISSION CONTROL NO: 190331
MYLAN-ATOMOXETINE Product Monograph
Page 2
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
................................................................... 28
STORAGE AND STABILITY
........................................