MINT-CLOPIDOGREL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Available from:

MINT PHARMACEUTICALS 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

Prescription type:

Prescription

Therapeutic area:

PLATELET AGGREGATION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2013-07-12

Summary of Product characteristics

_MINT-CLOPIDOGREL (Clopidogrel Tablets) _
_Page 1 of 59 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 and 300 mg Clopidogrel, as clopidogrel bisulfate, Oral
House Standard
Platelet Aggregation Inhibitor
Date of Initial
Authorization:
JUL 12,
2013
Date of Revision:
APR 13,
2023
Mint
Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, ON, L5T 2M3
Canada
Submission
Control
No.:
273299
_MINT-CLOPIDOGREL (Clopidogrel Tablets) _
_Page 2 of 59 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic 04/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS ..............................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1 INDICATIONS
............................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS.............................................................................................................
5
4 DOSAGE AND ADMINISTRATION
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5
4.2 Recommended Dose and Dosage Adjustment
................................................................... 5
4.4 Administration
.....................................................................................................................
6
4.5 Missed Dose
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