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)

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)
Intented 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
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
Co. Dublin
Ireland
Tel. +353 1 8398600
E-mail: mylanireland.mahs@mylan.com

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 PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

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:

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