INLYTA TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AXITINIB

Disponible depuis:

PFIZER CANADA ULC

Code ATC:

L01EK01

DCI (Dénomination commune internationale):

AXITINIB

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

AXITINIB 5MG

Mode d'administration:

ORAL

Unités en paquet:

28/56/60

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0153228002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2012-07-12

Résumé des caractéristiques du produit

_ _
_INLYTA_
®
_ (axitinib) Product Monograph _
_Page 1 of 52_
PRODUCT MONOGRAPH
Pr
INLYTA
®
Axitinib
Tablets, 1 mg, 3 mg, 5 mg and 7 mg
Kinase Inhibitor, Anti-Tumour Agent
®
Pfizer Products ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
©
Pfizer Canada ULC, 2021
Date of Revision:
28 September 2021
Submission
Control No: 245813
_ _
_INLYTA_
®
_ (axitinib) Product Monograph _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS.............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
............................................................................................14
DRUG INTERACTIONS
............................................................................................25
DOSAGE AND ADMINISTRATION
.........................................................................26
OVERDOSAGE
..........................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
.........................................................29
STORAGE AND STABILITY
....................................................................................31
DOSAGE FORMS, COMPOSITION AND
PACKAGING...........................................32
PART II: SCIENTIFIC INFORMATION
.........................................................................
34
PHARMACEUTICAL INFORMATION
.....................................................................34
CLINICAL
TRIALS....................................................................................................35
DETAILED PHARMACOLOGY
.........................