MYLAN-ATOMOXETINE CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

N06BA09

INN:

ATOMOXETINE

dosage:

60MG

pharmaceutical_form:

CAPSULE

composition:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 60MG

administration_route:

ORAL

units_in_package:

30/100

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-07-12

SPC

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