Please note that this product was withdrawn from the Community register of designated orphan medicinal products in April 2013 on request of the sponsor.
On 6 March 2002, orphan designation (EU/3/02/086) was granted by the European Commission to Axcan Pharma International BV, the Netherlands, for porfimer sodium (for use with photodynamic therapy) for the treatment of high-grade dysplasia in Barrett's oesophagus.
Porfimer sodium (for use with photodynamic therapy) was authorised in the EU as PhotoBarr on 25 March 2004.
The sponsorship was transferred to Pinnacle Biologics B.V., the Netherlands, in August 2011.
The marketing authorisation was withdrawn on 20 April 2012.
EU/3/02/086: Public summary of positive opinion for orphan designation of porfimer sodium (for use with photodynamic therapy) for the treatment of high-grade dysplasia in Barrett’s oesophagus (PDF/148.11 KB)
First published: 28/02/2007
Last updated: 20/06/2013
EMEA/COMP/69/02 Rev. 5
Porfimer sodium (for use with photodynamic therapy)
|Disease / condition||
Treatment of high-grade dysplasia in Barrett's oesophagus
|Date of first decision||
|EU designation number||
Sponsor's contact details
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.