TAVALISSE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FOSTAMATINIB (FOSTAMATINIB DISODIUM)

Mevcut itibaren:

MEDISON PHARMA CANADA INC.

ATC kodu:

B02BX09

INN (International Adı):

FOSTAMATINIB

Doz:

150MG

Farmasötik formu:

TABLET

Kompozisyon:

FOSTAMATINIB (FOSTAMATINIB DISODIUM) 150MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

HEMOSTATICS

Ürün özeti:

Active ingredient group (AIG) number: 0162598001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2021-07-15

Ürün özellikleri

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TAVALISSE
®
Fostamatinib tablets
100 mg, 150 mg fostamatinib (as fostamatinib disodium hexahydrate)
Antihemorrhagics (ATC Code: B02BX09)
Date of Initial Approval:
November 17, 2020
Date of Revision:
July 12, 2021
Submission Control No.: 253525
TAVALISSE
®
is a registered trademark of Rigel Pharmaceuticals Inc. used under
license by
Medison Pharma Canada Inc.
Medison Pharma Canada Inc.
2-1176 Mount Pleasant Road
Toronto, Ontario
M4N 2T2
_ _
_ _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
...........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.3
Administration
........................................................................................................
7
4.4
Reconstitution
........................................................................................................
7
4.5
Missed Dose
..........................................................................................................
7
5
OVERDOSAGE
...............................................................................................................
7
6
DOSAG