TEVA-FEBUXOSTAT TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-01-2020
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Active ingredient:
FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE)
Available from:
TEVA CANADA LIMITED
ATC code:
M04AA03
INN (International Name):
FEBUXOSTAT
Dosage:
80MG
Pharmaceutical form:
TABLET
Composition:
FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE) 80MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ANTIGOUT AGENTS
Product summary:
Active ingredient group (AIG) number: 0152809001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-04-23
Summary of Product characteristics
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_TEVA-FEBUXOSTAT _
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PRODUCT MONOGRAPH
PR
TEVA-FEBUXOSTAT
Febuxostat Tablets
80 mg febuxostat (as febuxostat hemihydrate)
Preparations Inhibiting Uric Acid Production
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Revision:
January 27, 2020
Submission Control No: 234067
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_TEVA-FEBUXOSTAT _
_Page 2 of 32 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
..........................................................................................................19
DETAILED PHARMA
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