EU/3/06/387

Table of contents

About

On 25 July 2006, orphan designation (EU/3/06/387) was granted by the European Commission to Morgan Lewis & Bockius, United Kingdom, for amikacin sulfate (liposomal) for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis.

The sponsorship was transferred to Transave Inhalation Biotherapeutics Limited, United Kingdom, in July 2008. Transave Inhalation Biotherapeutics Limited changed its name to Insmed Limited in October 2011.

The sponsor’s address was updated in February 2019.

The sponsorship was transferred to Insmed Netherlands B.V., Netherlands, in February 2019.

Key facts

Active substance
Amikacin sulfate (liposomal)
Disease / condition
Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of first decision
25/07/2006
Outcome
Positive
EU designation number
EU/3/06/387

Sponsor's contact details

Insmed Netherlands B.V.
Building D Floor 4
Graadt Van Roggenweg 328-344
Utrecht
3531 AH
E-mail: tom.vanthienen@insmed.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;

How useful was this page?

Add your rating