On 17 April 2003, orphan designation (EU/3/03/140) was granted by the European Commission to Chiron Corporation Limited, United Kingdom, for tobramycin (inhalation powder) for the treatment of Pseudomonas aeruginos a lung infection in cystic fibrosis.
The sponsorship was transferred to Novartis Europharm Limited, United Kingdom, in October 2006.
Tobramycin (inhalation powder) has been authorised in the EU as Tobi Podhaler since 20 July 2011.
The sponsorship was transferred to Novartis Europharm Limited, Ireland, in May 2018.
The sponsorship was transferred to Mylan Ire Healthcare Limited, Ireland, in June 2019.
Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
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Review of designation
During its meeting of 6-7 October 2010, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/03/140 for Tobi Podhaler (tobramycin) as an orphan medicinal product for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis.
The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment.
As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained.
Documents related to this orphan designation evaluation
Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Tobi Podhaler (tobramycin) for the treatment of Pseudomonas aeruginosa lung infection in cys... (PDF/56.61 KB)
First published: 10/10/2011
Last updated: 10/10/2011
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: