This is a summary of the European public assessment report (EPAR) for Stayveer. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Stayveer.
For practical information about using Stayveer, patients should read the package leaflet or contact their doctor or pharmacist.
Stayveer : EPAR - Summary for the public (PDF/86.4 KB)
First published: 02/07/2013
Last updated: 02/07/2013
Stayveer : EPAR - Risk-management-plan summary (PDF/76.73 KB)
First published: 27/08/2019
|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||
05/09/2019 Stayveer - EMEA/H/C/002644 - II/0028
- 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.
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with World Health Organization (WHO) functional class III. Efficacy has been shown in:
- primary (idiopathic and familial) PAH;
- PAH secondary to scleroderma without significant interstitial pulmonary disease;
- PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology.
Some improvements have also been shown in patients with PAH WHO functional class II.
Stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.