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.
Uptravi : EPAR - Summary for the public (PDF/86.9 KB)
First published: 26/05/2016
Last updated: 19/07/2017
Uptravi : EPAR - Risk-management-plan summary (PDF/123.73 KB) (updated)
First published: 11/02/2021
Last updated: 11/02/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen Cilag International NV
|Date of issue of marketing authorisation valid throughout the European Union||
14/12/2020 Uptravi - EMEA/H/C/003774 - R/0030
- 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.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 29 March - 1 April 201601/04/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 201629/01/2016