TORRENT-CLOPIDOGREL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-09-2014
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Active ingredient:
CLOPIDOGREL (CLOPIDOGREL BISULFATE)
Available from:
TORRENT PHARMACEUTICALS LIMITED
ATC code:
B01AC04
INN (International Name):
CLOPIDOGREL
Dosage:
75MG
Pharmaceutical form:
TABLET
Composition:
CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG
Administration route:
ORAL
Units in package:
28/100/500
Prescription type:
Prescription
Therapeutic area:
PLATELET AGGREGATION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0134440001; AHFS:
Authorization status:
CANCELLED (UNRETURNED ANNUAL)
Authorization date:
2021-12-20
Summary of Product characteristics
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_Page 1 of 52_
PRODUCT MONOGRAPH
PR
TORRENT-CLOPIDOGREL
Clopidogrel Tablets USP
75 mg clopidogrel, as clopidogrel bisulphate
Platelet Aggregation Inhibitor
Torrent Pharmaceuticals Ltd.
Indrad – 382 721,
Dist. Mehsana
India
Distributed by:
Torrent Pharma Canada Inc.
Woodbridge, ON, L4H 2K4
Date of Revision:
July 24, 2014
Submission Control No: 175271
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_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIAL
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