SANDOZ ATORVASTATIN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Disponible des:

SANDOZ CANADA INCORPORATED

Codi ATC:

C10AA05

Designació comuna internacional (DCI):

ATORVASTATIN

Dosis:

80MG

formulario farmacéutico:

TABLET

Composición:

ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0133055004; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2010-05-19

Fitxa tècnica

_Sandoz Atorvastatin _
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_Page 1 of 63_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ATORVASTATIN
Atorvastatin Calcium Tablets
Tablets, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin
calcium trihydrate), Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Initial Authorization:
May 19, 2010
Date of Revision:
September 11, 2023
Submission Control Number: 274576
_Sandoz Atorvastatin _
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_Page 2 of 63_
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RECENT MAJOR LABEL CHANGES
2 Contraindications
7 Warnings and Precautions, Musculoskeletal
09/2023
7 Warnings and Precautions, Musculoskeletal
09/2023
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
......................................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.4