TEVA-PRAVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-07-2020
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Active ingredient:
PRAVASTATIN SODIUM
Available from:
TEVA CANADA LIMITED
ATC code:
C10AA03
INN (International Name):
PRAVASTATIN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
PRAVASTATIN SODIUM 10MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122563001; AHFS:
Authorization status:
APPROVED
Authorization date:
2003-01-08
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PRAVASTATIN
pravastatin sodium
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2020
Toronto, Ontario
Canada M1B 2K9
SUBMISSION CONTROL NO:
240026
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2
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
.............................................................................................
11
DRUG INTERACTIONS
.............................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................
17
OVERDOSAGE
...........................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 19
STORAGE AND STABILITY
.....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 21
PART II: SCIENTIFIC INFORMATION
................................................................... 23
PHARMACEUTICAL INFORMATION
.....................................................................
23
CLINICAL TRIALS
.....................................................................................................
24
DETAILED PHARMACOLOGY
................................................................................
30
TOXICOLOGY
.................................................
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