DOPTELET TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

AVATROMBOPAG (AVATROMBOPAG MALEATE)

Disponible des:

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

Codi ATC:

B02BX08

Designació comuna internacional (DCI):

AVATROMBOPAG

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

AVATROMBOPAG (AVATROMBOPAG MALEATE) 20MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

Active ingredient group (AIG) number: 0165201001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2023-11-03

Fitxa tècnica

_DOPTELET_
_®_
_ (avatrombopag) - Product Monograph _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DOPTELET
®
Avatrombopag Tablets
20 mg avatrombopag (as maleate), oral
ATC Code: B02BX08
Thrombopoietin Receptor Agonist
Swedish Orphan Biovitrum AB (publ)
SE-112 76
Stockholm, Sweden
Imported by:
C.R.I.
3544 North Service Road, Unit #400
Burlington, Ontario
L7N 3G2
Date of Initial Authorization:
NOV 3, 2023
Submission Control Number: 251688
DOPTELET is a registered trademark of AkaRx, Inc.
© 2023 Swedish Orphan Biovitrum AB (publ). All rights reserved.
_ _
_DOPTELET_
_®_
_ (avatrombopag) - Product Monograph _
_Page 2 of 36_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
..............................................................................................................
2
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
4.4
Administration
........................................................................................................
7
4.5
Missed Dose
...........................................