EZETIMIBE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

EZETIMIBE

Disponible des:

LABORATOIRE RIVA INC.

Codi ATC:

C10AX09

Designació comuna 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:

Estat d'Autorització:

APPROVED

Data d'autorització:

2018-07-11

Fitxa tècnica

_Product Monograph – EZETIMIBE _
_Page 1 of 30 _
PRODUCT MONOGRAPH
PR EZETIMIBE
Ezetimibe Tablets, USP
10 mg
Cholesterol Absorption Inhibitor
www.labriva.com
SUBMISSION CONTROL NO:
235246
Canada, J7C 3V4
Blainville, Quebec
660 Boul. Industriel
LABORATOIRE RIVA INC.
February 6, 2020
DATE OF REVISION:
_Product Monograph – EZETIMIBE _
_Page 2 of 30 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
.......................................................................................
3
INFORMATION SUMMARY PRODUCT INFORMATION
.......................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
19
TOXICOLOGY
..........