PRZ-ATORVASTATIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Disponible desde:

PHARMARIS CANADA INC

Código ATC:

C10AA05

Designación común internacional (DCI):

ATORVASTATIN

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-10-22

Ficha técnica

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRZ-ATORVASTATIN
Atorvastatin calcium tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium), Oral
USP
LIPID METABOLISM REGULATOR
Pharmaris Canada Inc.
8310-130 Street, Suite 102
Surrey, British Columbia
Canada, V3W 8J9
Date of Initial Authorization:
OCT 22, 2021
Date of Revision:
FEB 15, 2023
Submission Control No: 268085
_ PRZ-ATORVASTATIN (atorvastatin calcium) _
_ _
_Page 2 of 64 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
02/2023
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
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2
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics............................................................................................................
4
1.2
Geriatrics
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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
....................................................................................................
8
4.5
Missed dose
.........................