UPTRAVI TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SELEXIPAG

Available from:

JANSSEN INC

ATC code:

B01AC27

INN (International Name):

SELEXIPAG

Dosage:

1600MCG

Pharmaceutical form:

TABLET

Composition:

SELEXIPAG 1600MCG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

VASODILATING AGENTS

Product summary:

Active ingredient group (AIG) number: 0157750008; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-01-20

Summary of Product characteristics

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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.
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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
.................................................