EU/3/00/014

About

Please note that this product was withdrawn from the Community register of designated orphan medicinal products in September 2013 at the end of the period of market exclusivity.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.

Key facts

Active substance
iloprost
Medicine name
Ventavis
Disease / condition
Treatment of primary and of the following forms of secondary pulmonary hypertension…
Date of decision
30/12/2000
Outcome
Expired
Orphan decision number
EU/3/00/014

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Please note that this product (marketed as Ventavis) was withdrawn from the Community register of designated orphan medicinal products in September 2013 at the end of the period of market exclusivity.

Sponsor's contact details

Bayer Pharma AG
D-13342 Berlin
Germany
Tel. +49 214 305 1348
Fax +49 214 305 1603
E-mail: medical-information@bayerhealtcare.com

Patients' organisations

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.

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