Volibris is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
PAH is abnormally high blood pressure in the arteries of the lungs. Volibris is used in patients with class II or III disease. The ‘class’ reflects the seriousness of the disease: ‘class II’ involves slight limitation of physical activity and ‘class III’ involves marked limitation of physical activity. Volibris has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Volibris contains the active substance ambrisentan.
Volibris : EPAR - Medicine overview (PDF/100.64 KB)
First published: 29/04/2008
Last updated: 16/07/2019
Volibris : EPAR - Risk-management-plan summary (PDF/267.09 KB)
First published: 11/02/2019
Last updated: 28/09/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
GlaxoSmithKline (Ireland) Limited
|Date of issue of marketing authorisation valid throughout the European Union||
22/09/2021 Volibris - EMEA/H/C/000839 - X/0061/G
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).