EU/3/04/204

Table of contents

About

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in September 2019 at the end of the 10-year period of market exclusivity.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 (inhalation use)
Disease / condition
Treatment of Gram-negative bacterial lung infection in cystic fibrosis
Date of first decision
21/06/2004
Outcome
Expired
EU designation number
EU/3/04/204

Sponsor's contact details

Gilead Sciences Ireland UC
Carrigtohill
County Cork
T45 DP77
Ireland
Tel:  +353 21 48 25500
E-mail: regulatory.orphan@gilead.com

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.

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