Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris bv-srl - azelastine hydrochloride 1 mg/ml - nasal spray, solution - 1 mg/ml - azelastine hydrochloride 1 mg/ml - azelastine

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - fluticasone propionate, quantity: 50 microgram/actuation; azelastine hydrochloride, quantity: 137 microgram/actuation (equivalent: azelastine, qty 125 microgram/actuation) - spray, nasal - excipient ingredients: glycerol; disodium edetate; phenethyl alcohol; purified water; carmellose sodium; microcrystalline cellulose; polysorbate 80; benzalkonium chloride - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - fluticasone propionate, quantity: 50 microgram/actuation; azelastine hydrochloride, quantity: 137 microgram/actuation (equivalent: azelastine, qty 125 microgram/actuation) - spray, nasal - excipient ingredients: disodium edetate; purified water; glycerol; microcrystalline cellulose; polysorbate 80; phenethyl alcohol; benzalkonium chloride; carmellose sodium - 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.

Malta - English - Medicines Authority

zentiva k.s. u kabelovny 130, dolní mecholupy, 102 37 praha 10, czech republic - nasal spray, solution - azelastine hydrochloride 1 mg - nasal preparations

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - azelastine hydrochloride - eye drops - 500microgram/1ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

meda pharma gmbh & co. kg - azelastine (azelastine hydrochloride) - drops eye - 0,5mg/ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

meda pharma gmbh & co. kg - azelastine (azelastine hydrochloride) - drops eye - 0,5mg/ml

Philippines - English - FDA (Food And Drug Administration)

stangen pharma'l phils inc - azelastine hydrochloride - solution, ophthalmic - 500mcg/ml

United States - English - NLM (National Library of Medicine)

meda pharmaceuticals - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - astelin nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. limited data from postmarketing experience over decades of use with astelin in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose.  oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096 mg. however, the relevance of these findings

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

towa pharmaceutical co., ltd. - azelastine hydrochloride - white tablet, diameter: 6.2 mm, thickness: 3.0 mm