XALKORI CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CRIZOTINIB

Tilgængelig fra:

PFIZER CANADA ULC

ATC-kode:

L01ED01

INN (International Name):

CRIZOTINIB

Dosering:

250MG

Lægemiddelform:

CAPSULE

Sammensætning:

CRIZOTINIB 250MG

Indgivelsesvej:

ORAL

Enheder i pakken:

60

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0153140002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2012-04-25

Produktets egenskaber

_XALKORI (crizotinib) _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XALKORI
®
Crizotinib
Capsules, 200 mg and 250 mg, oral
Protein Kinase Inhibitor (L01XE16)
™
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
®
Pfizer Inc.
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC, 2023
Date of Initial Authorization:
APR 25, 2012
Date of Revision:
APR 17, 2023
Submission Control Number: 270202
_ _
_XALKORI (crizotinib) _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
04/2023
7 Warnings and Precautions
04/2023
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 ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
.....................