Dovprela (previously Pretomanid FGK)

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pretomanid

Authorised
This medicine is authorised for use in the European Union.

Overview

Pretomanid FGK is a medicine for treating adults with drug-resistant tuberculosis. It is used to treat tuberculosis that is:

  • extensively drug-resistant (resistant to at least 4 antibiotics used for treating tuberculosis, including the standard antibiotics isoniazid and rifampicin);
  • multi-drug resistant (resistant to isoniazid and rifampicin) and when antibiotics used for this form of tuberculosis do not work or cause unacceptable side effects.

Pretomanid FGK is used together with bedaquiline and linezolid.

Pretomanid FGK contains the active substance pretomanid.

Tuberculosis is rare in the EU, and Pretomanid FGK was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 November 2007.

This EPAR was last updated on 09/02/2021

Authorisation details

Product details
Name
Dovprela (previously Pretomanid FGK)
Agency product number
EMEA/H/C/005167
Active substance
Pretomanid
International non-proprietary name (INN) or common name
pretomanid
Therapeutic area (MeSH)
Tuberculosis, Multidrug-Resistant
Anatomical therapeutic chemical (ATC) code
J04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Mylan IRE Healthcare Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
31/07/2020
Contact address

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Product information

14/01/2021 Dovprela (previously Pretomanid FGK) - EMEA/H/C/005167 - T/0002

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Pharmacotherapeutic group

Antimycobacterials

Therapeutic indication

Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

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