ATORVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Tersedia dari:

PRO DOC LIMITEE

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:

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:

2010-06-03

Karakteristik produk

_ATORVASTATIN (atorvastatin calcium) _
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_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATORVASTATIN
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
PRO DOC LTÉE.
2925, Boul. Industriel
Laval, Québec
Canada H7L 3W9
Date of Initial Authorization:
July 27, 2010
Date of Revision:
June 27, 2022
Submission Control Number: 264735
_ATORVASTATIN (atorvastatin calcium) _
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_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
06/2022
7 Warnings and Precautions, Musculoskeletal
06/2022
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
...................................................