Dovprela (pretomanid) receives positive CHMP opinion for on variation to marketing authorisation for treatment of TB – Viatris

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Dovprela. (pretomanid). The marketing authorisation holder is Mylan IRE Healthcare Limited (part of Viatris).

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 Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid and Dovprela is recommended 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.

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.