MYLAN-SIMVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-07-2019
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Active ingredient:
SIMVASTATIN
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C10AA01
INN (International Name):
SIMVASTATIN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
SIMVASTATIN 10MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122415004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-09-17
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
MYLAN-SIMVASTATIN
(Simvastatin Tablets)
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
DATE OF REVISION: July 31, 2019
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Submission Number: 230095
_ _
_Product Monograph –Mylan_-_Simvastatin _
_Page 2 of 50 _
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
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
27
DETAILED PHARMACOLOGY
...................................
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