TEVA-DASATINIB TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

DASATINIB (DASATINIB MONOHYDRATE)

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

L01EA02

INN (Jina la Kimataifa):

DASATINIB

Kipimo:

20MG

Dawa fomu:

TABLET

Tungo:

DASATINIB (DASATINIB MONOHYDRATE) 20MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

60

Dawa ya aina:

Prescription

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0152198001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-04-14

Tabia za bidhaa

_TEVA-DASATINIB (dasatinib) _
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_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) _
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_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
.......................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2 CONTRAINDICATIONS
..........................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4 DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.1 Dosing Considerations
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5
4.2 Recommende