TEVA-CLOPIDOGREL TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

B01AC04

INN (Internationale Bezeichnung):

CLOPIDOGREL

Dosierung:

75MG

Darreichungsform:

TABLET

Zusammensetzung:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/100/500

Verschreibungstyp:

Prescription

Therapiebereich:

PLATELET AGGREGATION INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2011-12-14

Fachinformation

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