APO-DIPYRIDAMOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-08-2021
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Active ingredient:
DIPYRIDAMOLE
Available from:
APOTEX INC
ATC code:
B01AC07
INN (International Name):
DIPYRIDAMOLE
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
DIPYRIDAMOLE 50MG
Administration route:
ORAL
Units in package:
250ML
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS VASODILATATING AGENTS
Product summary:
Active ingredient group (AIG) number: 0106621002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-08-12
Summary of Product characteristics
Page 1 of 18
PRODUCT MONOGRAPH
PR
APO-DIPYRIDAMOLE
DIPYRIDAMOLE TABLETS USP
25, 50, 75 AND 100 MG
PR
APO-DIPYRIDAMOLE-SC
DIPYRIDAMOLE SUGAR-COATED TABLETS USP
25, 50 AND 75 MG
CORONARY VASODILATOR
INHIBITOR OF PLATELET ADHESION AND AGGREGATION
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
AUGUST 10, 2021
CONTROL NUMBER: 246833
Page 2 of 18
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT
INFORMATION......................................................................................
3
INDICATIONS AND CLINICAL USES
.........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................................
3
ADVERSE
REACTIONS.............................................................................................................
4
DRUG INTERACTIONS
.............................................................................................................
5
DOSAGE AND ADMINISTRATION
.............................................................................................
6
OVERDOSAGE..........................................................................................................................
6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
6
STORAGE AND STABILITY
.......................................................................................................
7
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................................. 7
PART II: SCIENTIFIC INFORMATION
...........................................................................................
9
PHARMACEUTICAL INFORMATION
.............................................
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