NTP-PRAVASTATIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PRAVASTATIN SODIUM

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

C10AA03

INN (Tên quốc tế):

PRAVASTATIN

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

PRAVASTATIN SODIUM 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HMG-COA REDUCTASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0122563001; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2017-06-13

Đặc tính sản phẩm

PRODUCT MONOGRAPH
Pr
NTP-PRAVASTATIN
pravastatin sodium tablets
10, 20 and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 166140
Date of Preparation:
July 23, 2013
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................
5
ADVERSE REACTIONS
.............................................................................................
10
DRUG INTERACTIONS
.............................................................................................
14
DOSAGE AND ADMINISTRATION
.........................................................................
16
OVERDOSAGE
...........................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 17
STORAGE AND STABILITY
.....................................................................................
19
PART II: SCIENTIFIC INFORMATION
................................................................... 21
PHARMACEUTICAL INFORMATION
.....................................................................
21
CLINICAL TRIALS
.....................................................................................................
22
DETAILED PHARMACOLOGY
................................................................................
28
TOXICOLOGY
............................................................................................................
29
REFERENCES
................................................