TARO-DEFERASIROX (TYPE J) TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DEFERASIROX

Available from:

TARO PHARMACEUTICALS INC

ATC code:

V03AC03

INN (International Name):

DEFERASIROX

Dosage:

360MG

Pharmaceutical form:

TABLET

Composition:

DEFERASIROX 360MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

HEAVY METAL ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0151733006; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-11-05

Summary of Product characteristics

_Taro-Deferasirox (Type J) Page 1 of 54 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-DEFERASIROX (TYPE J)
deferasirox
Tablets, 90 mg, 180 mg, 360 mg; oral
Iron chelating agent
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario L6T 1C1
Date of Initial Authorization:
November 05, 2020
Date of Revision:
June 16, 2023
Submission Control No: 268760
_Taro-Deferasirox (Type J) Page 2 of 54 _
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RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
06/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations; 4.2
Recommended Dose
and Dosage Adjustment
06/2023
7 WARNINGS AND PRECAUTIONS; Ear/Nose/Throat;
Hepatic/Biliary/Pancreatic;
Monitoring and Laboratory Tests; Renal
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
(2 to 16
years of age)
06/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................................................
4
1
INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
Serious Warnings and Precautions
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