EU/3/07/513

About

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)
Disease / condition
Treatment of tuberculosis
Date of first decision
29/11/2007
Outcome
Positive
EU designation number
EU/3/07/513

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 .

Sponsor's contact details

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

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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