EU/3/04/209: Orphan designation for the prevention of graft rejection after lung transplantation


Table of contents


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.

Key facts

Active substance
Intended use
Prevention of graft rejection after lung transplantation
Orphan designation status
EU designation number
Date of designation

Zambon S.p.A.
Via Lillo Del Duca 10
20091 Bresso (MI)
Tel: +39 02 66524256

Documents related to this orphan designation evaluation

Patients' organisations

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:

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