MINT-SIMVASTATIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

SIMVASTATIN

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

C10AA01

INN (International Name):

SIMVASTATIN

Dosering:

40MG

Lægemiddelform:

TABLET

Sammensætning:

SIMVASTATIN 40MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100/1000

Recept type:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0122415002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2011-08-29

Produktets egenskaber

_MINT-SIMVASTATIN_
_ _
_(simvastatin) _
Page 1 of 60
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-SIMVASTATIN
Simvastatin Tablets
Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, Oral
USP
Lipid Metabolism Regulator
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario L5T 2M3
Date of Initial Authorization:
AUG 29, 2011
Date of Revision:
JAN 24, 2024
Submission Control Number: 278911
_MINT-SIMVASTATIN_
_ _
_(simvastatin) _
Page 2 of 60
_ _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
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
...........................