REDDY-DASATINIB TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DASATINIB (DASATINIB (S)-PROPYLENE GLYCOL)

Fáanlegur frá:

DR REDDY'S LABORATORIES LTD

ATC númer:

L01EA02

INN (Alþjóðlegt nafn):

DASATINIB

Skammtar:

100MG

Lyfjaform:

TABLET

Samsetning:

DASATINIB (DASATINIB (S)-PROPYLENE GLYCOL) 100MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0152198004; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-04-09

Vara einkenni

Page 1 of 69
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
REDDY-DASATINIB
Dasatinib Tablets
20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg dasatinib (as Dasatinib
(S)-
propylene glycol)
Protein kinase inhibitor
MANUFACTURED BY:
DATE OF INITIAL AUTHORIZATION:
DR. REDDY’S LABORATORIES LTD.,
August 06, 2021
Bachupally – 500 090 India
DATE OF REVISION:
IMPORTED AND DISTRIBUTED BY:
June 3, 2022
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1
Canada
SUBMISSION CONTROL NUMBER: 259831
Page 2 of 69
RECENT MAJOR LABEL CHANGES
None at the time of authorization
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 Recommended Dose and Dosage Adjustment
........................................................... 6
4.4 Administration
....................