On 29 December 2000, orphan designation (EU/3/00/014) was granted by the European Commission to Schering AG , Germany, for iloprost for the 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 and chronic thromboembolic pulmonary hypertension.
Iloprost has been authorised in the EU as Ventavis since 16 September 2003.
Schering AG changed name to Bayer Schering Pharma AG in February 2008 and subsequently to Bayer Pharma AG in October 2011.
For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.
EU/3/00/014: Iloprost for the treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug-induced pulmonary hypertension, portopulmonary hyp... (PDF/133.7 KB)
First published: 12/03/2009
Last updated: 08/10/2013
EMEA/COMP/617901/2008 Rev. 3
|Disease / condition||
Treatment of primary and of the following forms of secondary pulmonary hypertension…
|Date of decision||
|Orphan decision number||
Review of designation
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.