UPTRAVI TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

SELEXIPAG

Disponible des:

JANSSEN INC

Codi ATC:

B01AC27

Designació comuna internacional (DCI):

SELEXIPAG

Dosis:

400MCG

formulario farmacéutico:

TABLET

Composición:

SELEXIPAG 400MCG

Vía de administración:

ORAL

Unidades en paquete:

60

tipo de receta:

Prescription

Área terapéutica:

VASODILATING AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0157750002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2016-01-20

Fitxa tècnica

_~db5_O86888dc76b8743cbbde36e6d10b4eb1b.docx _
_EDMS-RIM-516055 v12.0 _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
UPTRAVI
®
Selexipag Film-coated tablets
200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, and
1600 mcg
Professed standard
Prostacyclin (PGI
2
) receptor (IP receptor) agonist
Janssen Inc
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
January 20, 2016
Date of Revision:
April 21, 2022
Submission Control Number: 258347
© 2022 Janssen Inc.
All trademarks used under licence.
_~db5_O86888dc76b8743cbbde36e6d10b4eb1b.docx _
_EDMS-RIM-516055 v12.0 _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment, Dosage adjustment with co-administration of moderate
CYP2C8
inhibitors
06/2020
7 WARNINGS AND PRECAUTIONS
11/2021
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
...............................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.................................................