MYLAN-EZETIMIBE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

EZETIMIBE

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C10AX09

INN (Nama Antarabangsa):

EZETIMIBE

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

EZETIMIBE 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CHOLESTEROL ABSORPTION INHIBITORS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2017-05-08

Ciri produk

Page 1 of 30
PRODUCT MONOGRAPH
PR MYLAN-EZETIMIBE
Ezetimibe Tablets
10 mg
Cholesterol Absorption Inhibitor
Professed
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M9Z 2S6
Date of Revision: January 08, 2015
Submission Control No: 180299
Page 2 of 30
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
OVEROSAGE
.................................................................................................................
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
.......................................................................................................
18
TOXICOLOGY
...............................................................................................................
22
REFERENCES
........................