PMS-ATORVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

C10AA05

INN (Nama Antarabangsa):

ATORVASTATIN

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2018-06-08

Ciri produk

_pms-ATORVASTATIN (atorvastatin calcium) _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
USP
Lipid Metabolism Regulator
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization
JUN 08, 2018
Date of Revision:
MAR 25, 2022
Submission Control Number: 260400
_pms-ATORVASTATIN (atorvastatin calcium) _
_Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2021
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
03/2022
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.......................................................... 6
4.4
Administration..........................