AURO-DEFERASIROX (TYPE J) TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DEFERASIROX

Disponibbli minn:

AURO PHARMA INC

Kodiċi ATC:

V03AC03

INN (Isem Internazzjonali):

DEFERASIROX

Dożaġġ:

90MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

DEFERASIROX 90MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0151733004; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-06-02

Karatteristiċi tal-prodott

_Auro-Deferasirox Product Monograph _ Page 1 of 53
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DEFERASIROX (TYPE J)
Deferasirox Tablets
Film-coated Tablets, 90 mg, 180 mg, 360 mg, oral
Iron chelating agent
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
June 2, 2022
Date of Revision:
March 22, 2023
Submission Control Number: 268479
_Auro-Deferasirox Product Monograph _ Page 2 of 53
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
03/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations; 4.2
Recommended
Dose
and Dosage Adjustment
03/2023
7 WARNINGS AND PRECAUTIONS; Ear/Nose/Throat;
Hepatic/Biliary/Pancreatic;
Monitoring and Laboratory Tests; Renal
03/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
(2 to 16
years of age)
03/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1 INDICATIONS
..........................................................................................................................
4
1.1 Pediatrics
.....................................................................................................................
4
1.2 Geriatrics
.....................................................................................................................
4
2 CONTRAINDICATIONS
............................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................................
5
4 DOSAGE AND ADMINISTRATIO