EZETIMIBE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

EZETIMIBE

Disponible desde:

SIVEM PHARMACEUTICALS ULC

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:

2014-09-15

Ficha técnica

PRODUCT MONOGRAPH
PR
EZETIMIBE
EZETIMIBE TABLETS
10 MG
MANUFACTURER’S STANDARD
Cholesterol Absorption Inhibitor
Sivem Pharmaceuticals ULC
Date of Revision:
4705 Dobrin Street
January 17, 2017
St. Laurent, Quebec
H4R 2P7
www.sivem.ca
SUBMISSION CONTROL NO.: 200952
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
7
DRUG INTERACTIONS
............................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
14
STORAGE AND STABILITY
....................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 15
PART II: SCIENTIFIC INFORMATION
...................................................................................17
PHARMACEUTICAL INFORMATION
....................................................................................
17
CLINICAL TRIALS
.................................................................................