JAMP-SIMVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-06-2019
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Active ingredient:
SIMVASTATIN
Available from:
JAMP PHARMA CORPORATION
ATC code:
C10AA01
INN (International Name):
SIMVASTATIN
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
SIMVASTATIN 20MG
Administration route:
ORAL
Units in package:
21/30/100/500/1000
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122415003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2013-07-08
Summary of Product characteristics
_Jamp-Simvastatin (simvastatin) tablets_
_Page 1 of 47_
PRODUCT MONOGRAPH
PR
JAMP-SIMVASTATIN
Simvastatin Tablets, USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Lipid Metabolism Regulator
JAMP Pharma Corporation
Date of Revision:
1310 rue Nobel
June 14, 2019
Boucherville, Québec,
Canada
J4B 5H3
Submission Control No: 227575
_Jamp-Simvastatin (simvastatin) tablets_
_Page 2 of 47_
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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