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.
Treatment of Gram-negative bacterial lung infection in cystic fibrosis
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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: