NOVO-DIPIRADOL TAB 75MG TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-10-2006
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Active ingredient:
DIPYRIDAMOLE
Available from:
NOVOPHARM LIMITED
ATC code:
B01AC07
INN (International Name):
DIPYRIDAMOLE
Dosage:
75MG
Pharmaceutical form:
TABLET
Composition:
DIPYRIDAMOLE 75MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS VASODILATATING AGENTS
Product summary:
Active ingredient group (AIG) number: 0106621003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2005-08-10
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
NOVO-DIPIRADOL (dipyridamole) 25, 50, 75, 100 mg Tablets
Pr
DIPYRIDAMOLE FOR INJECTION (dipyridamole) 5 mg/mL, USP
Coronary Vasodilator
Inhibitor of Platelet Adhesion and Aggregation
Novopharm Limited
Date of Preparation:
30 Novopharm Court
October 26, 2006
Toronto, Ontario
M1B 2K9
Control No. 107491
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL
USE.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND
PRECAUTIONS.........................................................................................
4
ADVERSE
REACTIONS...........................................................................................................
5
DRUG INTERACTIONS
...........................................................................................................
8
DOSAGE AND
ADMINISTRATION.......................................................................................
9
OVERDOSAGE
.........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 10
STORAGE AND
STABILITY.................................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 11
PART II: SCIENTIFIC INFORMATION
...............................................................................
13
PHARMACEUTICAL
INFORMATION.........................................................
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