On 29 July 2004 orphan designation (EU/3/04/209) was granted by the European Commission to PARI Aerosol Research Institute, Germany, for ciclosporin (for inhalation use) for the prevention of graft rejection after lung transplantation.
The name of the sponsor changed to PARI Pharma GmbH in 2007.
The sponsorship was transferred to Breath Therapeutics GmbH, Germany, in August 2017.
The sponsor’s address was updated in July 2019.
The sponsorship was transferred to Zambon S.p.A. in March 2021.
Prevention of graft rejection after lung transplantation
|Orphan designation status||
|EU designation number||
|Date of designation||
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: