RATIO-PRAVASTATIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PRAVASTATIN SODIUM

Disponible desde:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Código ATC:

C10AA03

Designación común internacional (DCI):

PRAVASTATIN

Dosis:

40MG

formulario farmacéutico:

TABLET

Composición:

PRAVASTATIN SODIUM 40MG

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: 0122563003; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2014-09-19

Ficha técnica

Product Monograph – ratio-PRAVASTATIN
Page 1 of 40
PRODUCT MONOGRAPH
PR
RATIO-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
_ _
_ _
_ _
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RATIOPHARM INC.
17 800 Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Date of Revision:
April 12, 2011
Submission Control No: 145497
Product Monograph – ratio-PRAVASTATIN
Page 2 of 40
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.......................................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................................
3
CONTRAINDICATIONS
....................................................................................................................
5
ADVERSE
REACTIONS..................................................................................................................11
DRUG
INTERACTIONS...................................................................................................................15
OVERDOSAGE
.................................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY..........................................................................18
STORAGE AND
STABILITY..........................................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................20
PART II: SCIENTIFIC INFORMATION
................................................................................21
CLINICAL
TRIALS...........................................................................................................................22
DETAILED
PHARMACOLOGY....................................................................................................27
REFERENCES....................................................