BOSULIF TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

BOSUTINIB (BOSUTINIB MONOHYDRATE)

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

L01EA04

INN (International Nazwa):

BOSUTINIB

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET

Skład:

BOSUTINIB (BOSUTINIB MONOHYDRATE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

28/120

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0155230001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2014-03-07

Charakterystyka produktu

_BOSULIF_
_®_
_ (bosutinib tablets) _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BOSULIF®
bosutinib tablets
Tablets, 100 mg, 400 mg and 500 mg, Oral
Protein-tyrosine kinase inhibitor
® Wyeth LLC,
Pfizer Canada ULC, licensee
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
©Pfizer Canada ULC, 2021
Date of Initial Authorization:
MAR 07, 2014
Date of Revision:
NOV 4, 2021
Submission Control Number: 253533
_BOSULIF_
_®_
_ (bosutinib tablets) _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
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 ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
.........................................................................