POTELIGEO (Kyowa Kirin Australia Pty Ltd)
Product name
POTELIGEO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
167 (175 working days)
Active ingredients
mogamulizumab
Registration type
NCE/NBE
Indication
POTELIGEO (concentrate for solution for infusion) is indicated for the treatment of adult patients (≥18 years of age) with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.