FEBUXOSTAT TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE)

Mevcut itibaren:

SANIS HEALTH INC

ATC kodu:

M04AA03

INN (International Adı):

FEBUXOSTAT

Doz:

80MG

Farmasötik formu:

TABLET

Kompozisyon:

FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE) 80MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2023-07-21

Ürün özellikleri

PRODUCT MONOGRAPH
PR
FEBUXOSTAT
Febuxostat Tablets
Tablets,
80 mg febuxostat (as febuxostat hemihydrate), Oral
Preparations Inhibiting Uric Acid Production
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Control #
276288
Page
1
of
32
Date of
Preparation:
July 21, 2023
Page 2 of 32
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION 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
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
............................................................................................................
18
DETAILED PHARMACOLOGY
.......................................................................................
24
TOXICOLOGY
........................................