TEVA-CLOPIDOGREL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

제공처:

TEVA CANADA LIMITED

ATC 코드:

B01AC04

INN (국제 이름):

CLOPIDOGREL

복용량:

75MG

약제 형태:

TABLET

구성:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

관리 경로:

ORAL

패키지 단위:

30/100/500

처방전 유형:

Prescription

치료 영역:

PLATELET AGGREGATION INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2011-12-14

제품 특성 요약

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
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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