Active-ingredient Dossier

["azelastine Hydrochloride"

Active-ingredient Dossier for ["azelastine Hydrochloride" (antihistamine nasal spray). Australian brands, products, PBS listings, PBAC outcomes —…

What is

Azelastine Hydrochloride Azelastine Hydrochloride is an antihistamine nasal spray.

Australian brands containing

Azelastine Hydrochloride — DYLASTINE — DYMISTA — EYEZEP — MISTY-DUO — APO-AZELASTINE/FLUTICASONE — ASTEPRO — AZELASTINE/FLUTICASONE — AZEP — BI-EASE — EZE — FLAZAIRE

Therapeutic areas

Azelastine Hydrochloride is registered in respiratory therapeutic area with 7 brands and ophthalmology with 4 brands.

Sponsor landscape

The ingredient is marketed by five sponsors: Arrotex Pharmaceuticals, Teva Pharma, Viatris, Aspen Pharmacare, and Sandoz.

PBS and regulatory activity

The latest AusPAR on record is dated 16 December 2013, with two brands having AusPARs on record. No brands have PBAC outcomes on record.