Digoxin shortage — CA supply status & alternatives

Digoxin

ATC C01AA05

🇦🇺 AUST R 11105 · Aspen Pharma Pty Ltd

In supply · Australia

WHO Essential Medicine

Digoxine NativelleLANOXIN ADULT digoxin 500microgram/

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇺🇸 US🇩🇪 DE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.50DPMQ A$18.10details →

✓ 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)	Digoxin
Brand names	Digoxine Nativelle, LANOXIN ADULT digoxin 500microgram/
ATC level 5	C01AA05
ATC level 4	C01AA
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	ACCORD-UK LIMITED, MILPHARM LIMITED, BRISTOL LABORATORIES LIMITED, PROTHERICS UK LIMITED +4 more
Registrations on file	25
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$3.50

AEMP

Dispensed (DPMQ)

A$18.10

incl. fees

Pack

digoxin 250 microgram tablet, 100

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£1.09

Drug Tariff

🇺🇸 US

US$8.46

Acquisition

🇫🇷 FR

€1.82

Retail price

Substitution pathways 🇦🇺 Australia · TGA

—

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

◷

~1 month

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

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

3 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.

High concentration risk

C-Squared Pharma LTDDeccan Nutraceuticals PVT LTDAlchem International Private LTD

Manufacturing countries: India · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Oct 2020

Latest approval

Shortage status by regulator official notices

🇨🇦

Canada

HC · 1h ago

High

🇺🇸

United States

ANSM Ruptures · 3mo ago

High

🇩🇪

Germany

BfArM · 2d ago

Medium

🇦🇺

Australia

TGA · 2mo ago

Resolved

Recalls official enforcement reports

🇺🇸

DIGOXIN

Novitium Pharma LLC · Mar 2024

Class IIIdetails ↗

🇺🇸

DIGOXIN

Novitium Pharma LLC · Mar 2024

Class IIIdetails ↗

🇺🇸

Digoxin

Aidapak Services, LLC · July 2013

Class IIdetails ↗

🇺🇸

Digoxin

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Verified timeline regulator events

🇩🇪 31 July 2026

medium reported

🇦🇺 23 Dec 2025

Shortage resolved

🇨🇦 31 July 2024

high reported

🇺🇸 25 Aug 2023

high reported

🇨🇦 10 Mar 2017

high reported

Sources official regulators

🇨🇦

verified 1h ago

verify ↗

🇩🇪

BfArM

verified 2d ago

verify ↗

🇺🇸

ANSM Ruptures

verified 3mo ago

verify ↗

🇦🇺

TGA

verified 2mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders25 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
Digoxin Tablets Bp	62.5 MICROGRAM	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Digoxin Tablets Bp	250MCG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Digoxin Tablets Bp	125 MICROGRAM	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
DIGOXIN 125 MICROGRAM TABLETS	125 MICROGRAM	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
DIGOXIN 250 MICROGRAM TABLETS	250 MICROGRAM	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Digoxin Tablets Bp	0.25MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
Digoxin Tablets Bp	0.125MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
DIGOXIN 62.5 MICROGRAMS TABLETS	62.5 MICROGRAM	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
Digifab	40MG	solution	🇬🇧 GB	PROTHERICS UK LIMITED	Active
DIGOXIN 250 MICROGRAM/ML SOLUTION FOR INJECTION/INFUSION	250 MICROGRAM	injection	🇬🇧 GB	ASPEN PHARMA TRADING LIMITED	Active
DIGOXIN 50 MICROGRAMS/ML ORAL SOLUTION	50 MICROGRAM	solution	🇬🇧 GB	ASPEN PHARMA TRADING LIMITED	Active
DIGOXIN 0.0625MG TABLETS	0.0625MG	tablet	🇬🇧 GB	ASPEN PHARMA TRADING LIMITED	Active
DIGOXIN 0.125MG TABLETS	0.125MG	tablet	🇬🇧 GB	ASPEN PHARMA TRADING LIMITED	Active
DIGOXIN 0.25MG TABLETS	0.25MG	tablet	🇬🇧 GB	ASPEN PHARMA TRADING LIMITED	Active
Digoxin	.05mg/mL	solution	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active

+10 more registrations on file

Mederti Drug Report

Generated 3 July 2026 · Australia market · 4 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.