ACT SIMVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-12-2017
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Active ingredient:
SIMVASTATIN
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
C10AA01
INN (International Name):
SIMVASTATIN
Dosage:
80MG
Pharmaceutical form:
TABLET
Composition:
SIMVASTATIN 80MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122415005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-11
Summary of Product characteristics
_Product Monograph –_
ACT SIMVASTATIN
_ _
_Page 1 of 49_
PRODUCT MONOGRAPH
PR
ACT_ _SIMVASTATIN
Simvastatin Tablets
USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Lipid Metabolism Regulator
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
December 13, 2017
Submission Control #: 211134
_Product Monograph –_
ACT SIMVASTATIN
_ _
_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
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
............................................................................................
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