JAMP FEBUXOSTAT TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FEBUXOSTAT

Mevcut itibaren:

JAMP PHARMA CORPORATION

ATC kodu:

M04AA03

INN (International Adı):

FEBUXOSTAT

Doz:

80MG

Farmasötik formu:

TABLET

Kompozisyon:

FEBUXOSTAT 80MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

ANTIGOUT AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0152809001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-07-25

Ürün özellikleri

_JAMP FEBUXOSTAT Product Monograph_
_Page 1 of 30_
PRODUCT MONOGRAPH
PR
JAMP FEBUXOSTAT
Febuxostat Tablets, 80 mg
Preparations Inhibiting Uric Acid Production
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec,
J4B 5H3, Canada
Date of Revision:
March 24, 2020
Submission Control No: 235670
_JAMP FEBUXOSTAT Product Monograph_
_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
.....................................................................................
3
ADVERSE REACTIONS
........................................................................................................
6
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
.........................................................................