On 18 November 2016, orphan designation (EU/3/16/1778) was granted by the European Commission to Pharmalink AB, Sweden, for budesonide for the treatment of primary IgA nephropathy.
In January 2018, Pharmalink AB changed name to Calliditas Therapeutics AB.
The sponsor’s address was updated in July 2021.
Treatment of primary IgA nephropathy
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
|September 2022||The sponsorship was transferred from Calliditas Therapeutics AB, Sweden to STADA Arzneimittel AG, Germany in September 2022.|
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: