ARTG Entry
ADZYNMA
ARTG entry for ADZYNMA (apadamtase alfa, cinaxadamtase alfa), ARTG 469165 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Takeda Pharmaceuticals
- Active ingredient: apadamtase alfa, cinaxadamtase alfa
- Therapeutic area: Rare Disease
I appreciate your request, but
I'm unable to write a comprehensive Brand Dossier for ADZYNMA based on the provided source material. The only document available contains limited information about ARTG registration entries.
From the single source document, I can only establish:
What it is
ADZYNMA is a powder and solvent for injection containing apadamtase alfa and cinaxadamtase alfa, sponsored by Takeda Pharmaceuticals.
Regulatory history
ADZYNMA was first listed on the ARTG on 8 January 2026, with two strengths registered: 500 IU and 1500 IU powder and solvent for injection vials. ---
To complete a full Brand Dossier meeting the specified requirements, I would need access to source documents containing information about: — Approved indications — Dosing recommendations — Key safety warnings and contraindications — PBS listing details (strength, item count, restriction type, ex-manufacturer price) — Additional regulatory history (PBAC outcomes, AusPAR information, Black Triangle status if applicable)
Please provide additional source documents with this clinical and regulatory information.