APO-DIPYRIDAMOLE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

buyitnow

SPC SPC (SPC)
10-08-2021

active_ingredient:

DIPYRIDAMOLE

MAH:

APOTEX INC

ATC_code:

B01AC07

INN:

DIPYRIDAMOLE

dosage:

50MG

pharmaceutical_form:

TABLET

composition:

DIPYRIDAMOLE 50MG

administration_route:

ORAL

units_in_package:

250ML

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS VASODILATATING AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0106621002; AHFS:

authorization_status:

APPROVED

authorization_date:

2021-08-12

SPC

                                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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SPC SPC ֆրանսերեն 10-08-2021