Product Dossier
DYLASTINE
Product Dossier for DYLASTINE (azelastine (as hydrochloride), fluticasone propionate, Viatris). ARTG record, PBS listing, PBAC outcomes, AusPAR —…
- Sponsor: Viatris
- Active ingredient: azelastine (as hydrochloride), fluticasone propionate
- Therapeutic area: Respiratory
- Related brand: FLUTIFORM
- Related brand: AXOTIDE
- Related brand: DYMISTA
- Same area: NUCALA
- Same area: VENTOLIN
What it is
DYLASTINE is a nasal spray containing azelastine hydrochloride 125 micrograms and fluticasone propionate 50 micrograms per metered dose.
Approved indications
— Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.
Regulatory history
DYLASTINE received approval on 16 December 2013. The product was first listed on the ARTG on 14 January 2014.