SIMVASTATIN TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-08-2009
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Active ingredient:
SIMVASTATIN
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
C10AA01
INN (International Name):
SIMVASTATIN
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
SIMVASTATIN 40MG
Administration route:
ORAL
Units in package:
21/30/1000
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122415002; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-08-13
Summary of Product characteristics
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_Page 1 of 45_
PRODUCT MONOGRAPH
SIMVASTATIN TABLETS
(SIMVASTATIN)
USP
5 MG, 10 MG, 20 MG, 40 MG AND 80 MG
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc., Date of Preparation: August 21,
2009
2680 Matheson Blvd. East, Suite 200
Mississauga, ON L4W 0A5
Canada
SUBMISSION CONTROL NO: 131952
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_Page 2 of 45_
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..................................................................................................14
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
...............................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
...........................................................19
STORAGE AND
STABILITY.........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................19
PART II: SCIENTIFIC
INFORMATION................................................................................21
PHARMACEUTICAL
INFORMATION.........................................................................21
CLINICAL
TRIALS.........................................................................................................22
DETAILED
PHARMACOLOGY................................................
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