On 13 March 2002, orphan designation (EU/3/02/096) was granted by the European Commission to Swedish Orphan AB, Sweden, for nitisinone for the treatment of alkaptonuria.
In May 2014, the sponsor changed name to Swedish Orphan Biovitrum AB (publ).
Please note that this product was withdrawn from the Union Register of orphan medicinal products in March 2020 on request of the Sponsor.
|Disease / condition||
Treatment of alkaptonuria
|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.