EU/3/07/513: Orphan designation for the treatment of tuberculosis
(S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine (pretomanid)
Table of contents
Overview
On 29 November 2007, orphan designation (EU/3/07/513) was granted by the European Commission to Dr Ulrich Granzer, Germany, for (S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine for the treatment of tuberculosis.
The sponsorship was transferred to FGK Representative Service GmbH, Germany, in June 2015.
(S)-2-nitro-6-(4-(trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazine has been authorised in the EU as Pretomanid FGK since 31 July 2020.
The sponsorship was transferred to Mylan IRE Healthcare Limited, Ireland in December 2020.
Key facts
Active substance |
(S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine (pretomanid)
|
Intended use |
Treatment of tuberculosis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/07/513
|
Date of designation |
29/11/2007
|
Sponsor |
Mylan Ire Healthcare Limited |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Pretomanid FGK at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the
orphan medicine assessment report
.
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.
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: