TEVA-DEFERASIROX TABLET FOR SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-01-2018
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Active ingredient:
DEFERASIROX
Available from:
TEVA CANADA LIMITED
ATC code:
V03AC03
INN (International Name):
DEFERASIROX
Dosage:
125MG
Pharmaceutical form:
TABLET FOR SUSPENSION
Composition:
DEFERASIROX 125MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
HEAVY METAL ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0151733001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2020-06-09
Summary of Product characteristics
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_Teva-Deferasirox _
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PRODUCT MONOGRAPH
PR
TEVA-DEFERASIROX
Deferasirox Dispersible Tablets for Oral Suspension
125 mg, 250 mg, or 500 mg
Iron Chelating Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Revision:
January 9, 2018
Control No: 212373
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_Teva-Deferasirox _
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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
..........................................................................................................
10
DRUG INTERACTIONS
..........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.........................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 24
STORAGE AND STABILITY
..................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 27
PART II: SCIENTIFIC INFORMATION
..................................................................................
28
PHARMACEUTICAL INFORMATION
................................................................................
28
CLINICAL TRIALS
..........................................
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