Naloxone Hydrochloride shortage — BE supply status & alternatives

Naloxone Hydrochloride

—

🇦🇺 AUST R 355284 · AU Pharma Pty Ltd

In supply · Australia

Naloxon B. Braun

In supply · 🇦🇺 Australia · short in🇺🇸 US🇮🇹 IT🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$16.22DPMQ A$31.28details →

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Naloxone Hydrochloride
Brand names	Naloxon B. Braun
Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper
Controlled substance	No
Marketing-authorisation holders	AU Pharma Pty Ltd, Mundipharma Pty Ltd, KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO, ETHYPHARM +6 more
Registrations on file	30
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$16.22

AEMP

Dispensed (DPMQ)

A$31.28

incl. fees

Pack

naloxone hydrochloride 400 microgram/mL injection, 5 x 1 mL ampoules

Source: PBSEffective July 2026 · AUD

Substitution pathways 🇦🇺 Australia · TGA

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No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

How long have past shortages lasted? from 1 resolved event

◷

~26 months

Historical pattern from resolved shortage records — not a prediction of this event.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

6 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Moderate concentration risk

Aspen Oss BVMacfarlan Smith LTDFrancopia A Euroapi COSun Pharmaceutical Industries LTDNoramco LLCSiegfried LTD

Manufacturing countries: Netherlands, United Kingdom, India, United States, Switzerland · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Jan 2026

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

ANSM Ruptures · 1mo ago

High

🇮🇹

Italy

AIFA · 2d ago

Medium

🇧🇪

FAMHP · 1mo ago

Medium

Recalls official enforcement reports

🇺🇸

NARCAN

Cardinal Health Inc. · Mar 2021

Class IIdetails ↗

🇺🇸

NALOXONE HYDROCHLORIDE

HOSPIRA INC, LAKE FOREST · June 2018

Class Idetails ↗

Verified timeline regulator events

🇧🇪 8 May 2026

medium reported

🇮🇹 27 Mar 2026

medium reported

🇮🇹 17 Apr 2024

Shortage resolved

🇮🇹 31 July 2020

Shortage resolved

🇺🇸 4 June 2018

high reported

🇮🇹 18 Dec 2017

Shortage resolved

Sources official regulators

🇮🇹

AIFA

verified 2d ago

verify ↗

🇧🇪

FAMHP

verified 1mo ago

verify ↗

🇺🇸

ANSM Ruptures

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
Oxonal	5 mg	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 5/	2.5 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 10/	5 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 15/	7.5mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 20/	10 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 30/	15mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 40/	20 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 60/	30 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 80/	40 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 2.5/	1.25mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
Oxonal	40 mg	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
Oxonal	20 mg	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
Oxonal	10 mg	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
Oxycodone Hydrochloride/Naloxone Hydrochloride	10MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active
Oxycodone Hydrochloride/Naloxone Hydrochloride	20MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active

+15 more registrations on file

Mederti Drug Report

Generated 6 July 2026 · Australia market · 3 regulatory sources

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.