TEVA-SIMVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SIMVASTATIN

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

C10AA01

INN (Nama Internasional):

SIMVASTATIN

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

SIMVASTATIN 10MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2004-03-19

Karakteristik produk

_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
.............................................................................................
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
...................................................................................