Gadoteridol shortage — BE supply status & alternatives

Gadoteridol

—

🇦🇺 AUST R 72671 · Bracco Pty Ltd

In supply · Australia

Prohance

In supply · 🇦🇺 Australia · short in🇧🇪 BE

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Controlled substance
Active ingredient (INN)	Gadoteridol
Brand names	Prohance
Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper

Marketing-authorisation holders	Bracco Pty Ltd, Slate Run Pharmaceuticals, LLC

Registrations on file	4

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

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

Biophore India Pharmaceuticals PVT LTDAnhui Poly Pharm CO LTDShandong New Time Pharmaceutical CO LTDMsn Life Sciences Private LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders4 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
PROHANCE gadoteridol	4189.5mg	—	🇦🇺 AU	Bracco Pty Ltd	Active
PROHANCE gadoteridol	5586mg	—	🇦🇺 AU	Bracco Pty Ltd	Active
PROHANCE gadoteridol	2793mg	—	🇦🇺 AU	Bracco Pty Ltd	Active
GADOTERIDOL	279.3mg/mL	injection	🇺🇸 US	Slate Run Pharmaceuticals, LLC	Active

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.