ATORVASTATIN-10 TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Tersedia dari:

SIVEM PHARMACEUTICALS ULC

Kode ATC:

C10AA05

INN (Nama Internasional):

ATORVASTATIN

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Rute administrasi :

ORAL

Unit dalam paket:

90/100/500

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0133055001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-08-29

Karakteristik produk

_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
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_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN-10
PR
ATORVASTATIN-20
PR
ATORVASTATIN-40
PR
ATORVASTATIN-80
Atorvastatin Calcium Tablets
Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin
(as atorvastatin calcium propylene glycol solvate), Oral
USP
Lipid Metabolism Regulator
Sivem Pharmaceuticals ULC
Date of Initial Authorization:
4705 Dobrin Street
August 29, 2013
Saint-Laurent, Quebec, Canada
H4R 2P7
Date of Revision:
www.sivem.ca
March 14, 2023
Submission Control Number: 268525
_Product Monograph - ATORVASTATIN-10, -20, -40, -80 _
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_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
03/2023
7 Warnings and Precautions, Musculoskeletal
03/2023
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
..........................................................................................................
5
2
CONTRAINDICATIONS
.....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........................