EZETIMIBE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

EZETIMIBE

Tersedia dari:

LABORATOIRE RIVA INC.

Kode ATC:

C10AX09

INN (Nama Internasional):

EZETIMIBE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

EZETIMIBE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

CHOLESTEROL ABSORPTION INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-07-11

Karakteristik produk

_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
..........