MYLAN-ROSUVASTATIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Sẵn có từ:

MYLAN PHARMACEUTICALS ULC

Mã ATC:

C10AA07

INN (Tên quốc tế):

ROSUVASTATIN

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HMG-COA REDUCTASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0148963001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-04-10

Đặc tính sản phẩm

_Page 1 of 46 _
PRODUCT MONOGRAPH
PR
MYLAN-ROSUVASTATIN
Rosuvastatin Calcium Tablets
5 mg, 10 mg, 20 mg and 40 mg
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 205317
Date of Revision: May 11, 2017
_Page 2 of 46_
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
..................................................................................
10
DRUG INTERACTIONS
...................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................. 22
OVERDOSAGE
..................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................... 24
STORAGE AND STABILITY
..........................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING ........................... 27
PART II: SCIENTIFIC INFORMATION
............................................................... 28
PHARMACEUTICAL INFORMATION
........................................................ 28
CLINICAL TRIALS
..........................................................................................
29
DETAILED PHARMACOLOGY
.....................................................................
33
TOXICOLOGY
..................................................................................................
34
REFERENCES
...................................................................................................
40
P