Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ventavis   
Auth. number : EU/1/03/255
Active substance : Iloprost
Orphan market exclusivity for "Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug-induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease, chronic thromboembolic pulmonary hypertension" (based on designation EU/3/00/014) started on 18/09/2003
   10 years of market exclusivity
   This orphan market exclusivity has ended on 18/09/2013
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AC - Platelet aggregation inhibitors excluding Heparin
Chemical substance: B01AC11 - Iloprost
(See WHO ATC Index)
Indication: Treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Marketing Authorisation Holder: Bayer Pharma AG
D-13342 Berlin, Deutschland
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
18/09/2003 Centralised - Authorisation EMEA/H/C/474 (2003)3348 of 16/09/2003
16/04/2004 Centralised - Notification EMEA/H/C/474/N/1 (2004)1486 of 13/04/2004
14/10/2004 Centralised - Notification EMEA/H/C/474/N/2
Updated with Decision(2005)660 of 07/03/2005
25/11/2004 Centralised - Notification EMEA/H/C/474/N/4
Updated with Decision(2005)3436 of 05/09/2005
09/03/2005 Centralised - Annual reassessment EMEA/H/C/474/S/3 (2005)660 of 07/03/2005
08/09/2005 Centralised - Variation EMEA/H/C/474/II/5 (2005)3436 of 05/09/2005
04/05/2006 Centralised - Variation EMEA/H/C/474/II/6 (2006)1884 of 02/05/2006
01/06/2006 Centralised - Annual reassessment EMEA/H/C/474/S/7
12/06/2006 Centralised - Variation EMEA/H/C/474/II/8 (2006)2303 of 08/06/2006
27/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/474/II/9
29/01/2007 Centralised - Annual reassessment EMEA/H/C/474/S/10
10/04/2007 Centralised - Variation EMEA/H/C/474/IA/12
Updated with Decision(2007)2347 of 30/05/2007
01/06/2007 Centralised - Variation EMEA/H/C/474/II/11 (2007)2347 of 30/05/2007
04/10/2007 Centralised - Notification EMEA/H/C/474/N/13
Updated with Decision(2008)4111 of 28/07/2008
16/01/2008 Centralised - Variation EMEA/H/C/474/IA/16
Updated with Decision(2008)4111 of 28/07/2008
24/01/2008 Centralised - Annual reassessment EMEA/H/C/474/S/15
31/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/474/II/17
20/06/2008 Centralised - Variation EMEA/H/C/474/IA/21
Updated with Decision(2008)4111 of 28/07/2008
30/07/2008 Centralised - Variation EMEA/H/C/474/II/19, 20 (2008)4111 of 28/07/2008
04/09/2008 Centralised - Renewal EMEA/H/C/474/R/18 (2008)4951 of 02/09/2008
31/10/2008 Centralised - Variation EMEA/H/C/474/IA/24
Updated with Decision(2009)4240 of 27/05/2009
31/10/2008 Centralised - Variation EMEA/H/C/474/IA/23
Updated with Decision(2009)4240 of 27/05/2009
18/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/474/IB/26
31/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/474/IB/27
29/05/2009 Centralised - Annual reassessment EMEA/H/C/474/S/25 (2009)4240 of 27/05/2009
22/06/2009 Centralised - Notification EMEA/H/C/474/N/28
Updated with Decision(2010)1952 of 19/03/2010
17/11/2009 Centralised - Variation EMEA/H/C/474/IA/29
Updated with Decision(2010)1952 of 19/03/2010
23/03/2010 Centralised - Annual reassessment EMEA/H/C/474/S/30 (2010)1952 of 19/03/2010
18/05/2010 Centralised - Notification EMEA/H/C/474/N/31
Updated with Decision(2010)9626 of 20/12/2010
03/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/474/IA/34/G
30/09/2010 Centralised - Notification EMEA/H/C/474/N/35
Updated with Decision(2010)9626 of 20/12/2010
23/12/2010 Centralised - Variation EMEA/H/C/474/II/32 (2010)9626 of 20/12/2010
21/01/2011 Centralised - Annual reassessment EMEA/H/C/474/S/36
23/02/2011 Centralised - Variation EMEA/H/C/474/II/33 (2011)1187 of 21/02/2011
16/08/2011 Centralised - Variation EMEA/H/C/474/IA/37/G
Updated with Decision(2012)1859 of 15/03/2012
19/03/2012 Centralised - Annual reassessment EMEA/H/C/474/S/39 (2012)1859 of 15/03/2012
26/04/2012 Centralised - Variation EMEA/H/C/474/II/38/G (2012)2856 of 20/04/2012
14/12/2012 Centralised - Notification EMEA/H/C/474/N/40
Updated with Decision(2013)5613 of 26/08/2013
29/08/2013 Centralised - Renewal EMEA/H/C/474/R/42 (2013)5613 of 26/08/2013
18/09/2013 Centralised - (orphan status)
21/11/2013 Centralised - Variation EMEA/H/C/474/II/44
Updated with Decision(2014)5247 of 18/07/2014
22/07/2014 Centralised - Variation EMEA/H/C/474/X/43 (2014)5247 of 18/07/2014
06/11/2014 Centralised - Variation EMEA/H/C/474/IA/48
Updated with Decision(2015)7734 of 03/11/2015
06/11/2014 Centralised - Variation EMEA/H/C/474/IA/49
Updated with Decision(2015)7734 of 03/11/2015
05/11/2015 Centralised - Yearly update (2015)7734 of 03/11/2015