TEVA-EZETIMIBE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
16-02-2015
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
EZETIMIBE
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
C10AX09
INN (Alþjóðlegt nafn):
EZETIMIBE
Skammtar:
10MG
Lyfjaform:
TABLET
Samsetning:
EZETIMIBE 10MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
CHOLESTEROL ABSORPTION INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0149164001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2014-09-15
Vara einkenni
1
PRODUCT MONOGRAPH
PR
TEVA-EZETIMIBE
EZETIMIBE TABLETS
10 MG
Cholesterol Absorption Inhibitor
Teva Canada Limited.
Date of Revision:
30 Novopharm Court
February 10, 2015
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
SUBMISSION CONTROL NO.: 181469
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
............................................................................................................
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
............................................................................................
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