TEVA-DULOXETINE DR CAPSULE (DELAYED RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

N06AX21

INN (Tên quốc tế):

DULOXETINE

Liều dùng:

30MG

Dạng dược phẩm:

CAPSULE (DELAYED RELEASE)

Thành phần:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2021-07-29

Đặc tính sản phẩm

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_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
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_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
....................................................................