Volibris

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ambrisentan

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

Overview

This is a summary of the European public assessment report (EPAR) for Volibris. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Volibris.

This EPAR was last updated on 11/02/2019

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
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
GlaxoSmithKline (Ireland) Limited
Revision
19
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

31/01/2019 Volibris - EMEA/H/C/000839 - IAIN/0057/G

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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