Cefiderocol (1) – Fetcroja®

• Based on the criteria set out in Chapter 5, Section 15a of the VerfO for classifying an antibiotic as a reserve antibiotic, and taking into account the criteria for classifying an antibiotic as a reserve antibiotic published on the website of the Robert KochInstitute has published on its website pursuant to Section 35a(1c), fifth sentence, of SGB V, as well as the documents submitted by the applicant, the Federal Joint Committee (G-BA) has decided, to grant the following application by a pharmaceutical manufacturer for exemption of a finished drug from the obligation to submit evidence in accordance with Section 35a(1), sentence 3, points 2 and 3 of the SGB V:
• The application for exemption from the benefit assessment on the grounds of reserve status pursuant to Section 35a(1c) of the German Social Code, Book V (SGB V) is granted, as the information provided by the pharmaceutical manufacturer is sufficient to justify the classification of the active ingredient cefiderocol as a reserve antibiotic in accordance with Chapter 5, Chapter, Section 15a of the VerfO.

Courtesy translation only, please refer to the German original.