TEVA-ROSUVASTATIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

C10AA07

INN (Isem Internazzjonali):

ROSUVASTATIN

Dożaġġ:

10MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HMG-COA REDUCTASE INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2012-03-15

Karatteristiċi tal-prodott

TEVA-ROSUVASTATIN (Rosuvastatin Calcium Tablets) Page 1 of 59
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-ROSUVASTATIN
Rosuvastatin Calcium Tablets
Tablets, 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin (rosuvastatin
calcium), Oral
Teva Standard
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
March 15, 2012
Date of Revision:
January 23, 2023
Submission Control Number: 268778
TEVA-ROSUVASTATIN (Rosuvastatin Calcium Tablets) Page 2 of 59
RECENT MAJOR LABEL CHANGES
Not applicable
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
..................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
............................................................... 5
4.4 Administration
....................................................................