Uptravi

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selexipag

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Uptravi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Uptravi.

For practical information about using Uptravi, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 15/06/2018

Authorisation details

Product details
Name
Uptravi
Agency product number
EMEA/H/C/003774
Active substance
Selexipag
International non-proprietary name (INN) or common name
selexipag
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
B01AC27
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Actelion Registration Ltd
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
12/05/2016
Contact address
Chiswick Tower 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom

Product information

09/04/2018 Uptravi - EMEA/H/C/003774 - N/0018

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTITHROMBOTIC AGENTS

Therapeutic indication

Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.

Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

Assessment history

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