TEVA-DASATINIB TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DASATINIB (DASATINIB MONOHYDRATE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

L01EA02

INN (nume internaţional):

DASATINIB

Dozare:

80MG

Forma farmaceutică:

TABLET

Compoziție:

DASATINIB (DASATINIB MONOHYDRATE) 80MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0152198005; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-04-14

Caracteristicilor produsului

_TEVA-DASATINIB (dasatinib) _
_ _
_ _
_ _
_Page 1 of 77 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-DASATINIB
Dasatinib Tablets
Tablets, 20 mg, 50 mg, 70 mg, 80 mg and 100 mg dasatinib (as dasatinib
monohydrate), Oral
Protein Kinase Inhibitor
Teva Canada Limited
Date of Initial Authorization
30 Novopharm Court
April 14, 2020
Toronto, Ontario
M1B 2K9
Date of Revision:
March 29, 2023
Submission Control Number: 266668
_TEVA-DASATINIB (dasatinib) _
_ _
_ _
_ _
_Page 2 of 77 _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing Considerations
04/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dose Adjustment
04/2021
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
..........................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.....................................................................
5
4 DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommende