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.
Volibris : EPAR - Summary for the public (PDF/99.08 KB)
First published: 29/04/2008
Last updated: 12/01/2016
Volibris : EPAR - Risk-management-plan summary (PDF/145.24 KB)
First published: 11/02/2019
|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||
31/01/2019 Volibris - EMEA/H/C/000839 - IAIN/0057/G
- 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
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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. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.