Sufentanil shortage — CA supply status & alternatives

Sufentanil

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In supply · Australia

Zalviso

In supply · 🇦🇺 Australia · short in🇨🇦 CA

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

Active ingredient (INN)	Sufentanil
Brand names	Zalviso
Therapeutic category	Auto-created by EMA — Withdrawn / Refused / Revoked Medicines scraper
Controlled substance	No

Registrations on file	3

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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.

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.

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

1 API manufacturer

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.

Very high concentration risk

Specgx LLC

Manufacturing countries: United States · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🌐

Zalviso

FGK Representative Service GmbH · Aug 2022

Class Unifieddetails ↗

🇺🇸

Sufentanil

Assurance Infusion · Dec 2019

Class IIdetails ↗

🇺🇸

Sufentanil

Assurance Infusion · Dec 2019

Class IIdetails ↗

🇺🇸

Sufentanil

Assurance Infusion · Dec 2019

Class IIdetails ↗

🇺🇸

Sufentanil

The Compounding Pharmacy of America · June 2015

Class IIdetails ↗

🇺🇸

Sufentanil

The Compounding Pharmacy of America · June 2015

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders3 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
Sufentanil Citrate	50ug/mL	injection	🇺🇸 US	Hospira, Inc.	Active
Sufentanil Citrate Injection Usp	—	solution	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
Sufentanil Citrate	—	solution	🇨🇦 CA	HIKMA CANADA LIMITED	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.