Pretomanid (1) – Dovprela®

• The application for exemption from the requirement to submit evidence pursuant to Section 35a(1), third sentence, points 2 and 3 of the German Social Code, Book V (SGB V), on the grounds of reserve status pursuant to Section 35a(1c) of the SGB V, is granted, as the information provided by the pharmaceutical manufacturer is sufficient to justify the classification of the active ingredient pretomanid as a reserve antibiotic in accordance with Section 35a(1c), first sentence, of the German Social Code, Book V (SGB V).
• The exemption is granted because the antibiotic is indicated for a pathogen-specific indication in accordance with CPMP/EWP/558/95 Rev 3 for the treatment of infections caused by a multi-resistant pathogen, in accordance with the RKI’s list of indicators for classifying an antibiotic as a reserve antibiotic pursuant to Section Section 35a(1c), sentence 5, of the German Social Code, Book V (SGB V), for patients with limited treatment options and who require a marketing authorisation.
• In accordance with the marketing authorisation, the medicinal product may only be used in adults with pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis that is resistant to rifampicin.
• The application was therefore to be granted.

Courtesy translation only, please refer to the German original.