FEBUXOSTAT TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-07-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE)
Available from:
SANIS HEALTH INC
ATC code:
M04AA03
INN (International Name):
FEBUXOSTAT
Dosage:
80MG
Pharmaceutical form:
TABLET
Composition:
FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE) 80MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0152809001; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-07-21
Summary of Product characteristics
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
........................................
Read the complete document
