TEVA-SIMVASTATIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SIMVASTATIN

Available from:

TEVA CANADA LIMITED

ATC code:

C10AA01

INN (International Name):

SIMVASTATIN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

SIMVASTATIN 10MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0122415004; AHFS:

Authorization status:

APPROVED

Authorization date:

2004-03-19

Summary of Product characteristics

_TEVA-SIMVASTATIN Page 1 of 60 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-SIMVASTATIN
Simvastatin Tablets
Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, Oral
USP
Lipid Metabolism Regulator
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
April 30, 2010
Toronto, ON
M1B 2K9
Date of Revision:
Canada
February 20, 2024
www.tevacanada.com
Submission Control Number: 279407
_TEVA-SIMVASTATIN Page 2 of 60 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
02/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I:
HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics..............................................................................................................
4
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 6
4.4
Administration
.....................................................................................................
8
4.5
Missed Dose
...................................................................................