EU/3/08/566: Orphan designation for the treatment of cystic fibrosis

Levofloxacin hemihydrate

Table of contents


Please note that this product (marketed as Quinsair) was withdrawn from the Community Register of designated orphan medicinal products in February 2015 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 23 September 2008, orphan designation (EU/3/08/566) was granted by the European Commission to Mpex London Ltd, United Kingdom, for levofloxacin hemihydrate for the treatment of cystic fibrosis.

The sponsorship was transferred to Aptalis Pharma SAS, France, in July 2013.

Key facts

Active substance
Levofloxacin hemihydrate
Intended use
Treatment of cystic fibrosis
Orphan designation status
EU designation number
Date of designation
Aptalis Pharma SAS
Route de Bû
78550 Houdan
Tel. +33 1 3046 1900
Fax +33 1 3059 6547

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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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