Product Dossier
ALHEMO
Product Dossier for ALHEMO (concizumab, Novo Nordisk Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Novo Nordisk Pharmaceuticals
- Active ingredient: concizumab
- Therapeutic area: Haematology
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
ALHEMO is a concizumab solution for injection supplied in prefilled pens. It is available in four strengths: 15 mg / 1.5 mL, 60 mg / 1.5 mL, 150 mg / 1.5 mL, and 300 mg / 3 mL.
Approved indications
— Prophylaxis to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have haemophilia B with factor IX inhibitors.
Dosing overview
No dosing schedule is provided in the available source documents.
Key safety warnings
No safety information is provided in the available source documents.
Contraindications
No contraindication information is provided in the available source documents.
PBS listing
No PBS listing information is provided in the available source documents.
Regulatory history
ALHEMO received approval on 2023-07-03. The product was first listed on the Australian Register of Therapeutic Goods on 2023-07-05 in four strengths across four separate ARTG entries.