Volibris

RSS

ambrisentan

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

Overview

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.

This EPAR was last updated on 16/07/2019

Authorisation details

Product details
Name
Volibris
Agency product number
EMEA/H/C/000839
Active substance
ambrisentan
International non-proprietary name (INN) or common name
ambrisentan
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
C02KX02
Publication details
Marketing-authorisation holder
GlaxoSmithKline (Ireland) Limited
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
20/04/2008
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

14/02/2019 Volibris - EMEA/H/C/000839 - II/0055

Contents

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Pharmacotherapeutic group

Antihypertensives

Therapeutic indication

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. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

Assessment history

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