EU/3/00/014: Orphan designation for the treatment of primary and of the following forms of secondary pulmonary hypertension…
Table of contents
Please note that this product was withdrawn from the Community register of designated orphan medicinal products in September 2013 at the end of the period of market exclusivity.
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.
Treatment of primary and of the following forms of secondary pulmonary hypertension…
|Orphan designation status||
|EU designation number||
|Date of designation||
Bayer Pharma AG
Tel. +49 214 305 1348
Fax +49 214 305 1603
Review of designation
Please note that this product (marketed as Ventavis) was withdrawn from the Community register of designated orphan medicinal products in September 2013 at the end of the period of market exclusivity.
Documents related to this orphan designation evaluation
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
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: