Azelastine shortage — NL supply status & alternatives

Azelastine

ATC R01AC03

🇦🇺 AUST R 310747 · ENT Technologies Pty Ltd

In supply · Australia

AllergodilAzelastine HCl Ophthalmic Solution, USP, 0.05%

In supply · 🇦🇺 Australia · short in🇳🇱 NL

In supply in Australia

Reading today’s signals…

✓ 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

Active ingredient (INN)	Azelastine
Brand names	Allergodil, Azelastine HCl Ophthalmic Solution, USP, 0.05%

ATC level 4	R01AC

Therapeutic category	Canonical INN head (inn_resolution)

Controlled substance	No

Marketing-authorisation holders	ENT Technologies Pty Ltd, Mylan Health Pty Ltd, TEVA UK LIMITED, GENUS PHARMACEUTICALS LIMITED +13 more

Registrations on file	24

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.

Other markets

🇺🇸 US

US$2.32

Acquisition

🇬🇧 GB

£5.60

Drug Tariff

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

2 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.

High concentration risk

Gedeon Richter PLCUrquima SA

Country of manufacture not yet mapped · Source: FDA List of Drug Master Files

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders24 registrations · 17 MA holders

Product	Strength	Form	Market	MA holder	Status
EZE ALLERGY azelastine hydrochloride	1 mg	—	🇦🇺 AU	ENT Technologies Pty Ltd	Active
DYMISTA ALLERGY azelastine	125 microgram	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
Azelastine Hydrochloride/Fluticasone Propionate	137MCG	spray	🇬🇧 GB	TEVA UK LIMITED	Active
Azelastine Hcl/Fluticasone Propionate	137 MCG	suspension	🇬🇧 GB	GENUS PHARMACEUTICALS LIMITED	Active
Azelastine Hydrochloride	0.5 MG	solution	🇬🇧 GB	FDC INTERNATIONAL LIMITED	Active
Azelastine Hydrochloride/Fluticasone Propionate Zentiva	137MCG	spray	🇬🇧 GB	ZENTIVA PHARMA UK LIMITED	Active
Azelastine Hydrochloride/Fluticasone Propionate	137 MCG	suspension	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Azelastine Hydrochloride	0.5MG	solution	🇬🇧 GB	BROWN & BURK UK LIMITED	Active
Azelastine Hcl / Fluticasone Propionate	137 MCG	suspension	🇬🇧 GB	ALISSA HEALTHCARE RESEARCH LIMITED	Active
Azelastine/Fluticasone Nasal Spray	137 MICROGRAM	spray	🇬🇧 GB	VIATRIS PRODUCTS LIMITED	Active
Azelastine Hcl/Fluticasone Propionate Vygoris	137 MCG	suspension	🇬🇧 GB	VYGORIS LIMITED	Active
Azelastine Eye Drops	—	drops	🇬🇧 GB	COOPER CONSUMER HEALTH B.V.	Active
AZEP NASAL SPRAY azelastine	125µg	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
EYEZEP azelastine	0.457 mg	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
Dymista	125 microgram	—	🇦🇺 AU	Mylan Health Pty Ltd	Active

+9 more registrations on file

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.