AVA-PRAVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-03-2011
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Active ingredient:
PRAVASTATIN SODIUM
Available from:
AVANSTRA INC
ATC code:
C10AA03
INN (International Name):
PRAVASTATIN
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
PRAVASTATIN SODIUM 40MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122563003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2011-12-12
Summary of Product characteristics
Page 1 of 42
PRODUCT MONOGRAPH
Pr
AVA-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
AVANSTRA INC. DATE OF PREPARATION:
10761 – 25TH NE, SUITE 110, BUILDING “B” FEBRUARY 21, 2011
CALGARY, ALBERTA
T2C 3C2
CONTROL NO.: 145177
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
5
WARNINGS AND
PRECAUTIONS.......................................................................................
5
ADVERSE
REACTIONS.......................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE......................................................................................................................
18
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
19
STORAGE AND
STABILITY...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
.............................................................................
22
PHARMACEUTICAL
INFORMATION...............................................................................
22
CLINICAL TRIALS
...............................................................................................................
23
DETAILED PHARMACOLOGY
.......
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