On 16 December 2014, orphan designation (EU/3/14/1397) was granted by the European Commission to PlumeStars s.r.l., Italy, for amikacin sulfate for the treatment of Pseudomonas aeuriginosa lung infections in cystic fibrosis.

Key facts

Active substance
Amikacin sulfate
Disease / condition
Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of first decision
EU designation number

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

PlumeStars s.r.l.
Strada Inzani 1
43125 Parma
Tel. +39 0521 90 50 86

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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