RBX-ATORVASTATIN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Prieinama:

SUN PHARMA CANADA INC

ATC kodas:

C10AA05

INN (Tarptautinis Pavadinimas):

ATORVASTATIN

Dozė:

10MG

Vaisto forma:

TABLET

Sudėtis:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

90/500

Recepto tipas:

Prescription

Gydymo sritis:

HMG-COA REDUCTASE INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2021-06-18

Prekės savybės

Page 1 of 59
_Pr_
_RBX-ATORVASTATIN (Atorvastatin Calcium Tablets) Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RBX-ATORVASTATIN
Atorvastatin Calcium Tablets
10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium),
Oral
USP
Lipid Metabolism Regulator
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
JUL 17, 2012
Date of Revision:
JUN 27, 2022
Submission Control No: 260436
Page 2 of 59
_Pr_
_RBX-ATORVASTATIN (Atorvastatin Calcium Tablets) Product Monograph_
RECENT MAJOR LABEL CHANGES
2 Contraindications
06/2021
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
............