TEVA-FLUVASTATIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-11-2016
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Active ingredient:
FLUVASTATIN (FLUVASTATIN SODIUM)
Available from:
TEVA CANADA LIMITED
ATC code:
C10AA04
INN (International Name):
FLUVASTATIN
Dosage:
20MG
Pharmaceutical form:
CAPSULE
Composition:
FLUVASTATIN (FLUVASTATIN SODIUM) 20MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0125247002; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-12-11
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
TEVA-FLUVASTATIN
Fluvastatin Sodium Capsules
20 and 40 mg capsules
Teva Canada Standard
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No: 199645
Revision Date:
November 7, 2016
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
5
ADVERSE REACTIONS
..................................................................................................
11
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
18
OVERDOSAGE
.................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 20
STORAGE AND STABILITY
..........................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
........................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 23
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
..........................................................................
24
CLINICAL TRIALS
.....................................................................................................
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