Active-ingredient Dossier

Naloxone Hydrochloride Dihydrate

Active-ingredient Dossier for Naloxone Hydrochloride Dihydrate (opioid antagonist). Australian brands, products, PBS listings, PBAC outcomes — compiled…

What is

Naloxone Hydrochloride Dihydrate Naloxone Hydrochloride Dihydrate is an opioid antagonist.

Australian brands containing

Naloxone Hydrochloride Dihydrate — NALOXONE JUNO — NARCAN — NYXOID — ARX-Oxycodone/Naloxone — NALOXONE

Therapeutic areas

Naloxone Hydrochloride Dihydrate is registered in Oncology (4 brands), Neurology (4 brands), and Pain & Anaesthesia (1 brand).

Sponsor landscape

Six sponsors market naloxone hydrochloride dihydrate: Mundipharma, Juno Pharmaceuticals, Southern XP IP, Phebra, Boucher & Muir, and Maple Healthcare.

PBS and regulatory activity

Three brands containing naloxone hydrochloride dihydrate have PBS-listed items, with the latest PBS schedule date of 1 May 2026. The latest PBAC outcome on record is from 1 March 2019, with one brand having a PBAC outcome recorded and no brands with AusPARs on record.