NU-PRAVASTATIN TABLETS

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PRAVASTATIN SODIUM

Disponible desde:

NU-PHARM INC

Código ATC:

C10AA03

Designación común internacional (DCI):

PRAVASTATIN

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

PRAVASTATIN SODIUM 10MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0122563001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2012-09-04

Ficha técnica

Page 1 of 42
PRODUCT MONOGRAPH
Pr
NU-PRAVASTATIN
PRAVASTATIN SODIUM
10, 20 AND 40 MG TABLETS
LIPID METABOLISM REGULATOR
NU-PHARM INC.
1165 CREDITSTONE ROAD, UNIT 2
VAUGHAN, ON
DATE OF REVISION:
L4K 4N7
MARCH 3, 2011
_CONTROL # 144758 _
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
5
WARNINGS AND
PRECAUTIONS.......................................................................................
5
ADVERSE
REACTIONS.......................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE......................................................................................................................
18
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
19
STORAGE AND
STABILITY...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
.............................................................................
22
PHARMACEUTICAL
INFORMATION...............................................................................
22
CLINICAL TRIALS
...............................................................................................................
23
DETAILED PHARMACOLOGY
.....................................