TEVA-CLOPIDOGREL TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Disponível em:

TEVA CANADA LIMITED

Código ATC:

B01AC04

DCI (Denominação Comum Internacional):

CLOPIDOGREL

Dosagem:

75MG

Forma farmacêutica:

TABLET

Composição:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Via de administração:

ORAL

Unidades em pacote:

30/100/500

Tipo de prescrição:

Prescription

Área terapêutica:

PLATELET AGGREGATION INHIBITORS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2011-12-14

Características técnicas

TEVA-CLOPIDOGREL (Clopidogrel Tablets)
_ _
Page 1 of 68
_ _
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)
_ _
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