Product Dossier
NYXOID
Product Dossier for NYXOID (naloxone hydrochloride dihydrate, Mundipharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Mundipharma
- Active ingredient: naloxone hydrochloride dihydrate
- Therapeutic area: Pain Management
- Same area: PALEXIA
- Same area: OXYCONTIN
I apologize, but
I cannot write a Brand Dossier for NYXOID based on the provided documents.
The documents contain information about TARGIN (oxycodone/naloxone modified-release tablets) and minimal information about NYXOID (naloxone nasal spray). Specifically: — Document 1 is the full Product Information for TARGIN tablets—a different medicine entirely. — Document 2 confirms NYXOID is a naloxone nasal spray registered on the ARTG (item 309381) in 2018. — Document 3 provides only PBS listing details: nasal spray 1.8 mg, 2 PBS items, unrestricted, ex-manufacturer price A$49.30.
To write a compliant Brand Dossier for NYXOID, I would require: — The Product Information (PI) document for NYXOID nasal spray — Regulatory history (ARTG registration date, PBAC outcome if applicable, AusPAR if available) — Approved indications — Dosing information — Safety warnings and contraindications — Any Black Triangle status
The current sources do not contain sufficient information to populate the required sections with proper citations. I recommend obtaining the NYXOID Product Information document from the TGA before proceeding.