SANDOZ LOVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-03-2014
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Active ingredient:
LOVASTATIN
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
C10AA02
INN (International Name):
LOVASTATIN
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
LOVASTATIN 20MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0120669002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-08-01
Summary of Product characteristics
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_Sandoz Lovastatin _
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PRODUCT MONOGRAPH
PR SANDOZ LOVASTATIN
Lovastatin Tablets USP
20 mg and 40 mg
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision: March 20, 2014
Submission Control Number: 172518
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_Sandoz Lovastatin _
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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
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETAILED PHARMACOLOGY
............................................
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