ATORVASTATIN-10 TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Boleh didapati daripada:

SIVEM PHARMACEUTICALS ULC

Kod ATC:

C10AA05

INN (Nama Antarabangsa):

ATORVASTATIN

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

90/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2013-08-29

Ciri 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
..........................