Epoprostenol shortage — NL supply status & alternatives

Epoprostenol

ATC B01AC09

🇦🇺 AUST R 292849 · Sun Pharma ANZ Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🌐 CO🇳🇱 NL

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$33.28details →

✓ 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

ATC level 4
Active ingredient (INN)	Epoprostenol
ATC level 5	B01AC09

Therapeutic category	Auto-created by CBG-MEB (Netherlands) scraper

Controlled substance	No

Marketing-authorisation holders	Sun Pharma ANZ Pty Ltd, SANDOZ LIMITED, MERCURY PHARMACEUTICALS LIMITED, SUN PHARMACEUTICAL INDUSTRIES EUROPE BV +4 more

Registrations on file	14

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$33.28

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

epoprostenol 500 microgram injection, 1 vial

Source: PBSEffective July 2026 · AUD

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.

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

4 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

Pharmacia And Upjohn Sub Pfizer INCCayman Pharma SroMsn Laboratories Private LTDSun Pharmaceutical Industries LTD

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

Shortage status by regulator official notices

🌐

INVIMA · 21h ago

Medium

🇳🇱

Netherlands

CBG-MEB · 1mo ago

Medium

Verified timeline regulator events

🇳🇱 7 May 2026

medium reported

🌐 30 July 2025

medium reported

Sources official regulators

🌐

INVIMA

verified 21h ago

verify ↗

🇳🇱

CBG-MEB

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders14 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
Sun	500 microgram	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Sun	1.5 mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Epoprostenol Sodium	0.5 MG	solution	🇬🇧 GB	SANDOZ LIMITED	Active
Epoprostenol Sodium	1.5 MG	solution	🇬🇧 GB	SANDOZ LIMITED	Active
EPOPROSTENOL 0.5MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION	0.5MG	solution	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
EPOPROSTENOL 1.5MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION	1.5MG	solution	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
EPOPROSTENOL 1.5 MG POWDER FOR SOLUTION FOR INFUSION	1.5 MG	solution	🇬🇧 GB	SUN PHARMACEUTICAL INDUSTRIES EUROPE BV	Active
FLOLAN epoprostenol sodium	500 microgram	—	🇦🇺 AU	GlaxoSmithKline Australia Pty Ltd	Active
FLOLAN epoprostenol sodium	1.5 mg	—	🇦🇺 AU	GlaxoSmithKline Australia Pty Ltd	Active
VELETRI epoprostenol	1.5 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
VELETRI epoprostenol	500 microgram	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
epoprostenol	.5mg/10mL	injection	🇺🇸 US	SUN PHARMACEUTICAL INDUSTRIES, INC.	Active
epoprostenol	1.5mg/10mL	injection	🇺🇸 US	SUN PHARMACEUTICAL INDUSTRIES, INC.	Active
Epoprostenol For	—	solution	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Cancelled

Mederti Drug Report

Generated 5 July 2026 · Australia market · 2 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.