Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Volibris   
Auth. number : EU/1/08/451
INN : Ambrisentan
Orphan status based on designation EU/3/05/273 added on 24/04/2008
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C02 - Antihypertensives
Pharmacological subgroup: C02K - Other antihypertensives
Chemical subgroup: C02KX - Other antihypertensives
Chemical substance: C02KX02 - Ambrisentan
(See WHO ATC Index)
Indication: Volibris is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity.Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/04/2008 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/839 (2008)1638 of 21/04/2008
24/04/2008 Centralised - Authorisation EMEA/H/C/839 (2008)1637 of 21/04/2008
20/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/839/IB/1
02/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/839/IB/2
28/01/2009 Centralised - Variation EMEA/H/C/839/II/3 (2009)558 of 26/01/2009
02/03/2009 Centralised - Variation EMEA/H/C/839/II/4 (2009)1459 of 26/02/2009
09/04/2009 Centralised - Variation EMEA/H/C/839/II/5 (2009)2859 of 07/04/2009
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/839/IA/7
01/09/2009 Centralised - Variation EMEA/H/C/839/II/6 (2009)6729 of 28/08/2009
24/12/2009 Centralised - Variation EMEA/H/C/839/II/8 (2009)10696 of 21/12/2009
22/01/2010 Centralised - Variation EMEA/H/C/839/II/10 (2010)370 of 20/01/2010
25/03/2010 Centralised - Variation EMEA/H/C/839/II/9, 11, 12 (2010)2004 of 23/03/2010
19/10/2010 Corrigendum (2010)7270 corr of 15/10/2010
19/10/2010 Corrigendum (2010)7268 corr of 15/10/2010
25/01/2011 Centralised - Variation EMEA/H/C/839/II/34/G
Updated with Decision(2011)1216 of 21/02/2011
16/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/839/IA/15
02/03/2011 Centralised - Variation EMEA/H/C/839/II/14 (2011)1216 of 21/02/2011
16/05/2011 Centralised - Variation EMEA/H/C/839/IA/16
Updated with Decision(2011)6049 of 18/08/2011
28/07/2011 Centralised - Variation EMEA/H/C/839/IB/18
Updated with Decision(2011)6049 of 18/08/2011
22/08/2011 Centralised - Variation EMEA/H/C/839/II/17 (2011)6049 of 18/08/2011
19/12/2011 Centralised - Variation EMEA/H/C/839/II/20 (2011)9751 of 14/12/2011
26/03/2012 Centralised - Variation EMEA/H/C/839/II/19, 0021 (2012)2026 of 21/03/2012
17/04/2012 Centralised - Variation EMEA/H/C/839/II/24 (2012)2548 of 13/04/2012
30/05/2012 Centralised - Variation EMEA/H/C/839/II/25 (2012)3578 of 25/05/2012
07/08/2012 Centralised - Variation EMEA/H/C/839/II/26 (2012)5682 of 03/08/2012
17/01/2013 Centralised - Renewal EMEA/H/C/839/R/30 (2013)141 of 14/01/2013
18/04/2013 Centralised - Variation EMEA/H/C/839/IG/279
Updated with Decision(2014)2832 of 23/04/2014
19/02/2014 Centralised - Notification EMEA/H/C/839/N/34
Updated with Decision(2014)2832 of 23/04/2014
25/04/2014 Centralised - Yearly update (2014)2832 of 23/04/2014
26/06/2014 Centralised - Variation EMEA/H/C/839/II/35/G
25/09/2014 Centralised - Variation EMEA/H/C/839/II/38