We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
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.