NU-MIRTAZAPINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MIRTAZAPINE

Sẵn có từ:

NU-PHARM INC

Mã ATC:

N06AX11

INN (Tên quốc tế):

MIRTAZAPINE

Liều dùng:

15MG

Dạng dược phẩm:

TABLET

Thành phần:

MIRTAZAPINE 15MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTIDEPRESSANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0143928001; AHFS:

Tình trạng ủy quyền:

CANCELLED (UNRETURNED ANNUAL)

Ngày ủy quyền:

2018-03-28

Đặc tính sản phẩm

Page 1 of 32
PRODUCT MONOGRAPH
PR
NU-MIRTAZAPINE
Mirtazapine Tablets
USP
15 mg, 30 mg and 45 mg
Antidepressant
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural St., Units 1 & 2
October 14, 2009
Richmond Hill, Ontario
L4B 1E4
Control#: 133373
Page 2 of 32
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND
PRECAUTIONS.......................................................................................
3
ADVERSE
REACTIONS.........................................................................................................
7
DRUG INTERACTIONS
.......................................................................................................
12
DOSAGE AND ADMINISTRATION
...................................................................................
12
OVERDOSAGE......................................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
14
STORAGE AND
STABILITY...............................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 17
PART II: SCIENTIFIC INFORMATION
.............................................................................
19
PHARMACEUTICAL
INFORMATION...............................................................................
19
CLINICAL TRIALS
...............................................................................................................
20
DETAILED PHARMACOLOGY
...................................