SANDOZ ROSUVASTATIN TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Tillgänglig från:

SANDOZ CANADA INCORPORATED

ATC-kod:

C10AA07

INN (International namn):

ROSUVASTATIN

Dos:

5MG

Läkemedelsform:

TABLET

Sammansättning:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 5MG

Administreringssätt:

ORAL

Enheter i paketet:

30/100/500

Receptbelagda typ:

Prescription

Terapiområde:

HMG-COA REDUCTASE INHIBITORS

Produktsammanfattning:

Active ingredient group (AIG) number: 0148963004; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2012-03-15

Produktens egenskaper

_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
..............................................................................