ARTG Entry
UPLIZNA
ARTG entry for UPLIZNA (inebilizumab), ARTG 446050 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Amgen
- Active ingredient: inebilizumab
- Therapeutic area: Neurology
What it is
UPLIZNA is inebilizumab 100 mg/10 mL concentrated injection vial. Inebilizumab is a B-cell depleting monoclonal antibody.
Approved indications
— Treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive, as monotherapy.
Key safety warnings
The benefits of UPLIZNA outweighed its risks for the approved indication.
Regulatory history
UPLIZNA was approved on 2025-03-11. The medicine was first listed on the Australian Register of Therapeutic Goods (ARTG) on 2025-03-12 under licence category RE. The approval was based on a positive assessment of the medicine's quality, safety, and efficacy.