SANDOZ FLUVASTATIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-12-2016
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Active ingredient:
FLUVASTATIN (FLUVASTATIN SODIUM)
Available from:
SANDOZ CANADA INCORPORATED
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:
CANCELLED POST MARKET
Authorization date:
2018-10-10
Summary of Product characteristics
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_Sandoz Fluvastatin _
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PRODUCT MONOGRAPH
PR
SANDOZ FLUVASTATIN
Fluvastatin sodium capsules
20 and 40 mg
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Quebec
J4B 7K8
Date of Revision:
December 16, 2016
Control Number: 200153
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_Sandoz Fluvastatin _
_Page 2 of 49_
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
..........................................................................................................26
DETAILED PHARMACOLOGY
................................................................
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