TEVA-DULOXETINE DR CAPSULE (DELAYED RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

可用日期:

TEVA CANADA LIMITED

ATC代码:

N06AX21

INN（国际名称）:

DULOXETINE

剂量:

30MG

药物剂型:

CAPSULE (DELAYED RELEASE)

组成:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

给药途径:

ORAL

每包单位数:

30/100

处方类型:

Prescription

治疗领域:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0152350001; AHFS:

授权状态:

CANCELLED PRE MARKET

授权日期:

2021-07-29

产品特点

_ _
_TEVA-DULOXETINE _
_Page 1 of 81_
PRODUCT MONOGRAPH
PR
TEVA-DULOXETINE
Duloxetine Delayed Release Capsules, Mfr. Std.
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
August 21, 2019
Date of Revision:
August 29, 2019
Submission Control No: 230092
_ _
_TEVA-DULOXETINE _
_Page 2 of 81_
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
.................................................................................................
19
DRUG INTERACTIONS
.................................................................................................
37
DOSAGE AND ADMINISTRATION
.............................................................................
41
OVERDOSAGE
...............................................................................................................
44
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 45
STORAGE AND STABILITY
.........................................................................................
48
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 49
PART II: SCIENTIFIC INFORMATION
...............................................................................
50
PHARMACEUTICAL INFORMATION
.........................................................................
50
CLINICAL TRIALS
....................................................................