UPTRAVI TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

SELEXIPAG

Dostopno od:

JANSSEN INC

Koda artikla:

B01AC27

INN (mednarodno ime):

SELEXIPAG

Odmerek:

400MCG

Farmacevtska oblika:

TABLET

Sestava:

SELEXIPAG 400MCG

Pot uporabe:

ORAL

Enote v paketu:

60

Tip zastaranja:

Prescription

Terapevtsko območje:

VASODILATING AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-01-20

Lastnosti izdelka

_~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
.................................................