GLN-EZETIMIBE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

EZETIMIBE

Verfügbar ab:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC-Code:

C10AX09

INN (Internationale Bezeichnung):

EZETIMIBE

Dosierung:

10MG

Darreichungsform:

TABLET

Zusammensetzung:

EZETIMIBE 10MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/100/500

Verschreibungstyp:

Prescription

Therapiebereich:

CHOLESTEROL ABSORPTION INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-01-20

Fachinformation

PRODUCT MONOGRAPH
PR
GLN-EZETIMIBE
EZETIMIBE
TABLETS USP
10 mg
Cholesterol Absorption Inhibitor
Glenmark Pharmaceuticals Canada Inc.
500 King St. W., 3
rd
Floor
Toronto, ON
M5V 1L9
Date of Preparation:
JANUARY 19, 2017
Submission Control No: 195487
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
............................................................13
STORAGE AND
STABILITY..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL
INFORMATION..........................................................................16
CLINICAL TRIALS
..........................................................................................................17
TOXICOLOGY
.................................................................................................................22
BIBLIO