EU/3/04/204: Orphan designation for the treatment of Gram-negative bacterial lung infection in cystic fibrosis

Aztreonam lysinate

Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in September 2019 at the end of the 10-year period of market exclusivity.

On 21 June 2004, orphan designation EU/3/04/204 was granted by the European Commission to MoRa Pharm GmbH, Germany, for aztreonam lysinate (inhalation use) for the treatment of Gram-negative bacterial lung infection in cystic fibrosis.

The sponsorship was transferred to Parexel International Limited, United Kingdom, in July 2005 and subsequently to Gilead Sciences International Ltd, United Kingdom, in May 2007.

Aztreonam lysinate (inhalation use) has been authorised in the EU as Cayston since 21 September 2009.

The sponsorship was transferred to Gilead Sciences Ireland UC, Ireland, in May 2018.

Key facts

Active substance
Aztreonam lysinate
Intended use
Treatment of Gram-negative bacterial lung infection in cystic fibrosis
Orphan designation status
EU designation number
Date of designation

Gilead Sciences Ireland UC
County Cork
T45 DP77
Tel:  +353 21 48 25500

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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