SANDOZ ROSUVASTATIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

C10AA07

DCI (Dénomination commune internationale):

ROSUVASTATIN

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Mode d'administration:

ORAL

Unités en paquet:

30/100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HMG-COA REDUCTASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0148963001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2012-03-15

Résumé des caractéristiques du produit

_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ROSUVASTATIN
Rosuvastatin Calcium Tablets
Tablets, 5, 10, 20 and 40 mg rosuvastatin (as rosuvastatin calcium),
Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1K6
Date of Initial Authorization:
SEP 29, 2020
Date of Revision:
December 13, 2023
Submission Control Number: 278851
_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
02/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
12/2023
4.2 Recommended Dose and Dosage Adjustment
12/2023
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
..........................................................................................................................
4
2
CONTRAINDICATIONS
.............................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.............................................................................................
5
4.1
Dosing Considerations
..............................................................................