Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in August 2014 at the end of the period of market exclusivity.
On 14 February 2001, orphan designation (EU/3/01/020) was granted by the European Commission to Orphan Europe, France, for ibuprofen for the treatment of patent ductus arteriosus.
Ibuprofen has been authorised in the EU as Pedea since 29 July 2004.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
Treatment of patent ductus arteriosus
|Orphan designation status||
|EU designation number||
|Date of designation||
Orphan Europe SARL
Immeuble Le Wilson
70 Avenue du Général de Gaulle
Tel. +33 1 4773 6458
Fax +33 1 49 00 18 00
Documents related to this orphan designation evaluation
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: