MYLAN-ATOMOXETINE CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Sẵn có từ:

MYLAN PHARMACEUTICALS ULC

Mã ATC:

N06BA09

INN (Tên quốc tế):

ATOMOXETINE

Liều dùng:

100MG

Dạng dược phẩm:

CAPSULE

Thành phần:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 100MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0150434007; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-07-12

Đặc tính sản phẩm

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