EZETIMIBE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

EZETIMIBE

Disponible desde:

PRO DOC LIMITEE

Código ATC:

C10AX09

Designación común internacional (DCI):

EZETIMIBE

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

EZETIMIBE 10MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

tipo de receta:

Prescription

Área terapéutica:

CHOLESTEROL ABSORPTION INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0149164001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2018-01-10

Ficha técnica

_Ezetimibe _
_Page 1 of 28_
PRODUCT MONOGRAPH
Pr
EZETIMIBE
Ezetimibe Tablets
10 mg ezetimibe
Cholesterol Absorption Inhibitor
Pro Doc Ltée
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
January 10, 2018
Submission Control No.: 211911
_Ezetimibe _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 13
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................................................................................................
17
TOXICOLOGY
.....................................................................................