MYLAN-PRAVASTATIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PRAVASTATIN SODIUM

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

C10AA03

Designación común internacional (DCI):

PRAVASTATIN

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

PRAVASTATIN SODIUM 20MG

Vía de administración:

ORAL

Unidades en paquete:

30/100/500

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0122563002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2017-10-17

Ficha técnica

_Page 1 of _
_49_
PRODUCT MONOGRAPH
PR
MYLAN-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 205285
Date of Revision: May 12, 2017
_Page 2 of _
_49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION ............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
................................................................................