EU/3/07/469: Orphan designation for the treatment of cystic fibrosis


Table of contents


On 3 August 2007, orphan designation (EU/3/07/469) was granted by the European Commission to Bayer HealthCare AG, Germany, for ciprofloxacin (inhalation use) for the treatment of cystic fibrosis.

The sponsorship was transferred to Bayer Schering Pharma AG, Germany, in May 2009. Bayer Shering Pharma AG changed its name to Bayer Pharma AG in October 2011.

The sponsorship was transferred to Bayer AG, Germany, in August 2017.

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in October 2018 on request of the Sponsor.

Key facts

Active substance
Intended use
Treatment of cystic fibrosis
Orphan designation status
EU designation number
Date of designation

Bayer AG
51368 Leverkusen
Tel. +49 30 300 139 003

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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