Mirabegron shortage — CA supply status & alternatives

Mirabegron

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🇦🇺 AUST R 199664 · Astellas Pharma Australia Pty Ltd

In supply · Australia

Apo-Mirabegron

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

Controlled substance
Active ingredient (INN)	Mirabegron
Brand names	Apo-Mirabegron
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Marketing-authorisation holders	Astellas Pharma Australia Pty Ltd, QILU PHARMACEUTICAL CO., LTD., Lupin Pharmaceuticals, Inc., SANDOZ CANADA INCORPORATED +2 more

Registrations on file	7

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.

Other markets

🇪🇸 ES

€41.51

Retail price

🇺🇸 US

US$9.74

Acquisition

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

36 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.

Low concentration risk

Micro Labs LTDSynthimed Labs Private LTDAlivus Life Sciences LTDAarti Pharmalabs LTDDr Reddys Laboratories LTDMegafine Pharma P LTD+30 more

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders7 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
BETMIGA mirabegron	25 mg	—	🇦🇺 AU	Astellas Pharma Australia Pty Ltd	Active
BETMIGA mirabegron	50 mg	—	🇦🇺 AU	Astellas Pharma Australia Pty Ltd	Active
Mirabegron	25mg/1	tablet	🇺🇸 US	QILU PHARMACEUTICAL CO., LTD.	Active
MIRABEGRON	50mg/1	tablet	🇺🇸 US	Lupin Pharmaceuticals, Inc.	Active
Sandoz Mirabegron	—	tablet	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
Auro-Mirabegron	—	tablet	🇨🇦 CA	AURO PHARMA INC	Active
Apo-Mirabegron	—	tablet	🇨🇦 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.