AG-SIMVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-08-2022
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Active ingredient:
SIMVASTATIN
Available from:
ANGITA PHARMA INC.
ATC code:
C10AA01
INN (International Name):
SIMVASTATIN
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
SIMVASTATIN 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122415001; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-08-15
Summary of Product characteristics
_Page 1 of 47 _
_AG-Simvastatin (simvastatin) tablets _
PR
AG-
SIMVASTATIN
Simvastatin Tablets, USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Lipid Metabolism Regulator
Angita Pharma Inc
1310 rue Nobel
Boucherville, Québec,
Canada J4B 5H3
PRODUCT MONOGRAPH
Submission
Control
No: 265942
Date
of
Revision:
August 04,
2022
_Page 2 of 47 _
_AG-Simvastatin (simvastatin) tablets _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
5
WARNINGS AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
..................................................................................................
12
DRUG INTERACTIONS
...................................................................................................
15
DOSAGE AND ADMINISTRATION
...............................................................................
19
OVERDOSAGE
.................................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY..............................................................
21
STORAGE AND
STABILITY
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 22
PART II: SCIENTIFIC INFORMATION
.................................................................................
23
PHARMACEUTICAL INFORMATION
...........................................................................
23
CLINICAL
TRIALS.......................................................................................
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