Dovprela (previously Pretomanid FGK) - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

pretomanid

Opinion

On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Dovprela. The marketing authorisation holder for this medicinal product is Mylan IRE Healthcare Limited.

The CHMP adopted extensions to the existing indications as follows:

Dovprela is indicated in combination with bedaquiline, linezolid and moxifloxacin for the treatment of

• adults with pulmonary tuberculosis (TB) due to Mycobacteriumtuberculosis resistant to rifampicin, with or without resistance to isoniazid.

Dovprela is indicated in combination with bedaquiline and linezolid for the treatment of

• adults with pulmonary tuberculosis (TB) due to M.ycobacteriumtuberculosis resistant to all of isoniazid, rifampicin and, a fluroquinolone, and with or without resistance to isoniazid a second line injectable antibacterial drug and
• adults with pulmonary TB due to M. tuberculosis resistant to both isoniazid and rifampicin, who are treatment intolerant or nonresponsive to standard therapy (see sections 4.2, 4.4 and 5.1).

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

For information, the full indications for Dovprela will be as follows:

Dovprela is indicated in combination with bedaquiline, linezolid and moxifloxacin for the treatment of

• adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid.

Dovprela is indicated in combination with bedaquiline and linezolid for the treatment of

• adults with pulmonary TB due to M. tuberculosis resistant to rifampicin and a fluoroquinolone, with or without resistance to isoniazid (see sections 4.2, 4.4 and 5.1).

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

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Dovprela (EMAVR0000258124)

Adopted Reference Number: EMADOC-1700519818-2699355

Key facts

• Name of medicine:
  Dovprela (previously Pretomanid FGK)
• EMA 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 therapeutical chemical (ATC) code:
  J04
• Additional 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.

• Orphan:

  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.

• Marketing authorisation holder:
  Mylan IRE Healthcare Limited
• Date of opinion:
  11/12/2025
• Status:
  Positive