APO-CLOPIDOGREL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Available from:

APOTEX INC

ATC code:

B01AC04

INN (International Name):

CLOPIDOGREL

Dosage:

75MG

Pharmaceutical form:

TABLET

Composition:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

PLATELET AGGREGATION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2011-12-06

Summary of Product characteristics

_APO-CLOPIDOGREL (clopidogrel tablets) Product Monograph _
_Page 1 of 65 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 mg and 300 mg Clopidogrel, as clopidogrel bisulfate, Oral
USP
Platelet Aggregation Inhibitor
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JAN 04, 2013
Date of Revision:
JUN 19, 2023
Submission Control Number: 271440
_APO-CLOPIDOGREL (clopidogrel tablets) Product Monograph _
_Page 2 of 65 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
07/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
06/2023
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
Administration
............................................................................................................6
4.5
Missed
Dose...............................