EZETIMIBE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

EZETIMIBE

Saadav alates:

SIVEM PHARMACEUTICALS ULC

ATC kood:

C10AX09

INN (Rahvusvaheline Nimetus):

EZETIMIBE

Annus:

10MG

Ravimvorm:

TABLET

Koostis:

EZETIMIBE 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/100

Retsepti tüüp:

Prescription

Terapeutiline ala:

CHOLESTEROL ABSORPTION INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2014-09-15

Toote omadused

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
.................................................................................