APO-ATOMOXETINE CAPSULE
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
13-01-2016
该产品的某些文档当前不可用，您可以向我们的客户服务发送请求，我们将在获得它们后尽快通知您。
发送请求。
发送请求。
有效成分:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
可用日期:
APOTEX INC
ATC代码:
N06BA09
INN（国际名称）:
ATOMOXETINE
剂量:
80MG
药物剂型:
CAPSULE
组成:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 80MG
给药途径:
ORAL
每包单位数:
30/100/1000
处方类型:
Prescription
治疗领域:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
產品總結:
Active ingredient group (AIG) number: 0150434006; AHFS:
授权状态:
APPROVED
授权日期:
2010-09-21
产品特点
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
...............................................................
阅读完整的文件
