Ciclesonide shortage — AU supply status & alternatives

Ciclesonide

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🇦🇺 AUST R 93724

In shortage · Australia

OMNARIS ciclesonide

In declared shortage · 🇦🇺 Australia

Critical shortage

Product discontinued / no longer available on the Australian market.

Reading today’s signals…

🇦🇺 AUAEMPA$10.08DPMQ A$35.38details →

✓ 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

Brand names	OMNARIS ciclesonide

Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Advanz Pharma Limited, APOTEX INC

Registrations on file	6

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$10.08

AEMP

Dispensed (DPMQ)

A$35.38

incl. fees

Pack

ciclesonide 80 microgram/actuation inhalation, 120 actuations

Source: PBSEffective July 2026 · AUD

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

5 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

Dynamit Nobel GMBH Explosivstoff Und SystemtechnikSterling SPAAarti Pharmalabs LTDCoral Drugs PVT LTDNewchem SPA

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders6 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
Ciclesonide Advanz Pharma	80 MCG	solution	🇬🇧 GB	Advanz Pharma Limited	Active
Ciclesonide Advanz Pharma	160 MCG	solution	🇬🇧 GB	Advanz Pharma Limited	Active
ALVESCO ciclesonide	80 microgram	—	🇦🇺 AU	—	Active
ALVESCO ciclesonide	160 microgram	—	🇦🇺 AU	—	Active
OMNARIS ciclesonide	50 microgram	—	🇦🇺 AU	—	Active
Apo-Ciclesonide	—	spray	🇨🇦 CA	APOTEX INC	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.