TEVA-CLOPIDOGREL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

B01AC04

INN (nume internaţional):

CLOPIDOGREL

Dozare:

75MG

Forma farmaceutică:

TABLET

Compoziție:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Calea de administrare:

ORAL

Unități în pachet:

30/100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PLATELET AGGREGATION INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2011-12-14

Caracteristicilor produsului

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