MYLAN-ATORVASTATIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Disponible desde:

MYLAN PHARMACEUTICALS ULC

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:

90/500

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:

2012-10-30

Ficha técnica

_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR MYLAN-ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
OCT 30, 2012
Date of Revision:
OCT 23, 2023
Submission Control Number: 275378
_MYLAN-ATORVASTATIN _
_Atorvastatin (as Atorvastatin Calcium Trihydrate) _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
10/2023
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
.................................................................................................................
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