Gemcitabine shortage — NL supply status & alternatives

Gemcitabine

—

🇦🇺 AUST R 184743 · Juno Pharmaceuticals Pty Ltd

In supply · Australia

Gemcitabine Accord Healthcare

In supply · 🇦🇺 Australia · short in🇺🇸 US🇳🇱 NL🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$24.31details →

✓ 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

Brand names	Gemcitabine Accord Healthcare

Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper

Controlled substance	No

Marketing-authorisation holders	Juno Pharmaceuticals Pty Ltd, Hospira UK Limited, FRESENIUS KABI LIMITED, ACCORD HEALTHCARE LIMITED +6 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$24.31

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

gemcitabine 1 g/26.3 mL injection, 26.3 mL vial

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$20.00

Acquisition

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.

Shortage status by regulator official notices

🇳🇱

Netherlands

CBG-MEB · 11d ago

High

🇺🇸

United States

ANSM Ruptures · 1mo ago

High

🇧🇪

FAMHP · 1d ago

Medium

Recalls official enforcement reports

🇦🇺

Gemcitabine 1,615mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Bladder InfusionBatch N

Slade Health Pty Ltd · Apr 2026

Class IIdetails ↗

🇦🇺

GEMCITABINE 1,160MG IN 0.9% SODIUM CHLORIDE IN POLYOLEFIN BAG (FREEFLEX) FOR INTRAVENOUS INFUSIONBat

Slade Health Pty Ltd · Jan 2026

Class IIdetails ↗

🇺🇸

Gemcitabine

Edge Pharma, LLC · Dec 2021

Class IIdetails ↗

🇺🇸

Gemcitabine

Infusion Options, Inc. · June 2019

Class IIdetails ↗

🇺🇸

Gemcitabine For Injection

Mylan Institutional LLC · Mar 2015

Class Idetails ↗

🇺🇸

Gemcitabine For Injection

Mylan Institutional LLC · Mar 2015

Class Idetails ↗

Verified timeline regulator events

🇳🇱 29 June 2026

medium reported

🇳🇱 18 June 2026

high reported

🇧🇪 2 June 2026

medium reported

🇧🇪 28 May 2026

medium reported

🇧🇪 17 July 2025

medium reported

🇺🇸 23 Mar 2015

high reported

Sources official regulators

🇧🇪

FAMHP

verified 1d ago

verify ↗

🇳🇱

CBG-MEB

verified 1d ago

verify ↗

🇺🇸

ANSM Ruptures

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders25 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
An	2 g	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
GEMCITABINE 38MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION	38MG	solution	🇬🇧 GB	Hospira UK Limited	Active
GEMCITABINE 38MG/ML POWDER FOR SOLUTION FOR INFUSION	38MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active
GEMCITABINE 38 MG/ML POWDER FOR SOLUTION FOR INFUSION	38 MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active
GEMCITABINE 38 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION	38 MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active
GEMCITABINE 200MG POWDER FOR SOLUTION FOR INFUSION	200MG	solution	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
GEMCITABINE 1 G POWDER FOR SOLUTION FOR INFUSION	1 G	solution	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION	100 MG	solution	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
GEMCITABINE 2 G POWDER FOR SOLUTION FOR INFUSION	2 G	solution	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
GEMCITABINE 40MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION	40MG	solution	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
GEMCITABINE 1000 MG, POWDER FOR SOLUTION FOR INFUSION	1000 MG	solution	🇬🇧 GB	SUN PHARMACEUTICAL INDUSTRIES EUROPE BV	Active
GEMCITABINE 10 MG/ML SOLUTION FOR INFUSION	10 MG	solution	🇬🇧 GB	SUN PHARMACEUTICAL INDUSTRIES EUROPE BV	Active
GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION	200 MG	solution	🇬🇧 GB	VENUS PHARMA GMBH	Active
GEMCITABINE 1000 MG POWDER FOR SOLUTION FOR INFUSION	1000 MG	solution	🇬🇧 GB	VENUS PHARMA GMBH	Active
Gemcitabine	38mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active

+10 more registrations on file

Mederti Drug Report

Generated 3 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.