MYLAN-EZETIMIBE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

EZETIMIBE

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

C10AX09

INN (Nome Internazionale):

EZETIMIBE

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

EZETIMIBE 10MG

Via di somministrazione:

ORAL

Confezione:

30/100/500

Tipo di ricetta:

Prescription

Area terapeutica:

CHOLESTEROL ABSORPTION INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2017-05-08

Scheda tecnica

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