EZETIMIBE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

EZETIMIBE

Sẵn có từ:

SANIS HEALTH INC

Mã ATC:

C10AX09

INN (Tên quốc tế):

EZETIMIBE

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

EZETIMIBE 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CHOLESTEROL ABSORPTION INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0149164001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-01-07

Đặc tính sản phẩm

1
PRODUCT MONOGRAPH
PR
EZETIMIBE
EZETIMIBE TABLETS
10 MG
MANUFACTURER’S STANDARD
Cholesterol Absorption Inhibitor
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
January 11, 2022
Brampton, Ontario
L6Y 5S5
Submission Control No.: 259721
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
7
DRUG INTERACTIONS
............................................................................................................
10
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
13
STORAGE AND STABILITY
....................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 15
PART II: SCIENTIFIC INFORMATION
...................................................................................16
PHARMACEUTICAL INFORMATION
....................................................................................
16
CLINICAL TRIALS
.........................................................................................