RATIO-PRAVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-04-2011
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Active ingredient:
PRAVASTATIN SODIUM
Available from:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
ATC code:
C10AA03
INN (International Name):
PRAVASTATIN
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
PRAVASTATIN SODIUM 20MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122563002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2014-09-19
Summary of Product characteristics
Product Monograph – ratio-PRAVASTATIN
Page 1 of 40
PRODUCT MONOGRAPH
PR
RATIO-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
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_ _
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RATIOPHARM INC.
17 800 Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Date of Revision:
April 12, 2011
Submission Control No: 145497
Product Monograph – ratio-PRAVASTATIN
Page 2 of 40
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.......................................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................................
3
CONTRAINDICATIONS
....................................................................................................................
5
ADVERSE
REACTIONS..................................................................................................................11
DRUG
INTERACTIONS...................................................................................................................15
OVERDOSAGE
.................................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY..........................................................................18
STORAGE AND
STABILITY..........................................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................20
PART II: SCIENTIFIC INFORMATION
................................................................................21
CLINICAL
TRIALS...........................................................................................................................22
DETAILED
PHARMACOLOGY....................................................................................................27
REFERENCES....................................................
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