TEVA-ROSUVASTATIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

C10AA07

INN (Nome Internazionale):

ROSUVASTATIN

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Via di somministrazione:

ORAL

Confezione:

30/100/500

Tipo di ricetta:

Prescription

Area terapeutica:

HMG-COA REDUCTASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-03-15

Scheda tecnica

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
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2
PART I:
HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.....................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1 Dosing Considerations
..................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
............................................................... 5
4.4 Administration
....................................................................