TARO-DEFERASIROX TABLET FOR SUSPENSION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DEFERASIROX

Dostępny od:

TARO PHARMACEUTICALS INC

Kod ATC:

V03AC03

INN (International Nazwa):

DEFERASIROX

Dawkowanie:

500MG

Forma farmaceutyczna:

TABLET FOR SUSPENSION

Skład:

DEFERASIROX 500MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HEAVY METAL ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0151733003; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2017-06-26

Charakterystyka produktu

_TARO-DEFERASIROX (DEFERASIROX) _
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_PAGE 1 OF 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-DEFERASIROX
deferasirox
Dispersible Tablets for Suspension, 125 mg, 250 mg, or 500 mg, Oral
Iron chelating agent
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario L6T 1C1
Submission Control No: 268762
Date of Initial Authorization:
JUN 26, 2017
Date of Revision:
JUN 21, 2023
_TARO-DEFERASIROX (DEFERASIROX) _
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_PAGE 2 OF 56 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2023
4 DOSAGE AND ADMINISTRATTION; 4.2 Recommended Dose and Dosage
Adjustment
06/2023
7 WARNINGS AND PRECAUTIONS
06/2023
7 WARNINGS AND PRECAUTIONS; 7.1.3 Pediatrics
06/2023
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
TABLE OF CONTENTS
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 ADMINISTRATION
...............................................................................
5
4. 1
DOSING CONSIDERATIONS
......................................................................