ACT LOVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-05-2020
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Active ingredient:
LOVASTATIN
Available from:
TEVA CANADA LIMITED
ATC code:
C10AA02
INN (International Name):
LOVASTATIN
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
LOVASTATIN 40MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0120669001; AHFS:
Authorization status:
APPROVED
Authorization date:
2004-02-11
Summary of Product characteristics
ACT_ _LOVASTATIN
_ _
_Page 1 of 45_
PRODUCT MONOGRAPH
PR
ACT_ _LOVASTATIN
Lovastatin
20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control No. 236528
Date of Preparation:
April 8, 2020
ACT_ _LOVASTATIN
_ _
_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
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMACOLOGY
...................................
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