TEVA-CLOPIDOGREL TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

B01AC04

INN (Tên quốc tế):

CLOPIDOGREL

Liều dùng:

75MG

Dạng dược phẩm:

TABLET

Thành phần:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PLATELET AGGREGATION INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0134440001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2011-12-14

Đặc tính sản phẩm

TEVA-CLOPIDOGREL (Clopidogrel Tablets)
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Page 1 of 68
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 mg and 300 mg clopidogrel (as clopidogrel bisulfate), Oral
Teva Standard
Platelet Aggregation Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number: 267470
Date of Initial Authorization:
December 14, 2011
Date of Revision:
January 12, 2023
TEVA-CLOPIDOGREL (Clopidogrel Tablets)
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Page 2 of 68
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
03/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES…………………………………………………………..………………………………..2
TABLE OF
CONTENTS……………………………………………………………………………………………………………....2
PART I: HEALTH PROFESSIONAL
INFORMATION……………………………………………………………………...4
1
INDICATIONS……………………………………………………………………………………………………………………...4
1.1
Pediatrics…………………………………………………………………………………………………………………………4
1.2
Geriatrics…………………………………………………………………………………………………………………….…..4
2
CONTRAINDICATIONS………………………………………………………………………………………………………...5
4 DOSAGE AND
ADMINISTRATION………………………………………………………………………………...........5
4.2
Recommended Dose and Dosage
Adjustment………………………………………………………………….5
4.4
Adm