EZETIMIBE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

EZETIMIBE

Dostopno od:

SANIS HEALTH INC

Koda artikla:

C10AX09

INN (mednarodno ime):

EZETIMIBE

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

EZETIMIBE 10MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

CHOLESTEROL ABSORPTION INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-01-07

Lastnosti izdelka

1
PRODUCT MONOGRAPH
PR
EZETIMIBE
EZETIMIBE TABLETS
10 MG
MANUFACTURER’S STANDARD
Cholesterol Absorption Inhibitor
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
January 11, 2022
Brampton, Ontario
L6Y 5S5
Submission Control No.: 259721
2
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
............................................................................................................
10
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
.........................................................................................