Država: Kanada
Jezik: engleski
Izvor: Health Canada
SELEXIPAG
JANSSEN INC
B01AC27
SELEXIPAG
200MCG
TABLET
SELEXIPAG 200MCG
ORAL
10/60/140
Prescription
VASODILATING AGENTS
Active ingredient group (AIG) number: 0157750001; AHFS:
APPROVED
2016-01-20
_~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 ................................................. Pročitajte cijeli dokument