TEVA-CLOPIDOGREL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

B01AC04

Designació comuna internacional (DCI):

CLOPIDOGREL

Dosis:

300MG

formulario farmacéutico:

TABLET

Composición:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 300MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

PLATELET AGGREGATION INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0134440002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-06-22

Fitxa tècnica

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