Antibiotics

The consumption of antimicrobial medicines has risen sharply in recent decades, both in humans and animals. Antibiotics in particular, but also antiviral, antifungal and antiparasitic medicines, belong to the category of antimicrobial medicines. The frequent use of antimicrobial medicines has caused microbes to become increasingly resistant to these medicines. This is known as antimicrobial resistance or AMR.

Simultaneous national scientific advice pilot project: launch of phase 2

The European Innovation Network (EU IN) has launched phase 2 of the simultaneous national scientific advice (SNSA) pilot project. SNSA can be used when an applicant wants to obtain national scientific advice from more than one national competent authority (NCA) at the same time. The format is designed to enhance the quality and consistency of such advice. Following endorsement by the Heads of Medicines Agencies (HMA), phase 2 of the SNSA pilot project will run for a two-year period until the end of 2024. Phase 2 incorporates an optimised procedure to maximise the benefits for both applicants and competent authorities.

Minjuvi

Active substance    Tafasitamab
Holder Clinigen Healthcare Ltd on behalf of Incyte Ltd
Status closed
Indication the treatment of adult patients who have Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) and who are not eligible for autologous stem cell transplantation (ASCT)
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