EU/3/03/140

About

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.

Key facts

Active substance
Tobramycin (inhalation powder)
Medicine name
Tobi Podhaler
Disease / condition
Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of first decision
17/03/2003
Outcome
Positive
EU designation number
EU/3/03/140

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.

Sponsor's contact details

Mylan Ire Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
Co. Dublin 13
Ireland
E-mail: mylanireland.mahs@mylan.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;

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