MINJUVI (Specialised Therapeutics Alim Pty Ltd)
Product name
MINJUVI
Date registered
Evaluation commenced
Decision date
Approval time
218 (255 working days)
Active ingredients
tafasitamab
Registration type
EOI
Indication
Relapsed or Refractory Follicular Lymphoma
MINJUVI is indicated in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a).
Limitations of Use: MINJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.