On 7 November 2005, orphan designation (EU/3/05/325) was granted by the European Commission to Stricent AB, Sweden, for mannitolum for the treatment of cystic fibrosis.
The sponsorship was transferred to Pharmaxis UK Limited, United Kingdom, in October 2006. The sponsor subsequently changed name to Pharmaxis Pharmaceuticals Limited in May 2008.
Mannitolum has been authorised in the EU as Bronchitol since 13 April 2012.
The sponsorship was transferred to Pharmaxis Europe Limited, Ireland, in January 2019.
|Disease / condition||
Treatment of cystic fibrosis
|Date of first decision||
|EU designation number||
Review of designation
During its meeting of 8-9 November 2011, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/05/325 for Bronchitol (mannitol, previously known as mannitolum) as an orphan medicinal product for the treatment of cystic fibrosis. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained.
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.