Austrália - angličtina - 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.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - azelastine hydrochloride, quantity: 0.137 mg/actuation (equivalent: azelastine, qty 0.125 mg/actuation) - spray, nasal - excipient ingredients: dibasic sodium phosphate dodecahydrate; disodium edetate; hypromellose; purified water; citric acid; sodium chloride - for the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis.

Malta - angličtina - Medicines Authority

bausch + lomb ireland limited 3013 lake drive citywest business campus dublin 24, d24ppt, ireland - azelastine hydrochloride - nasal spray, solution - azelastine hydrochloride 0.14 mg - nasal preparations

Spojené štáty - angličtina - 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

Austrália - angličtina - 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: phenethyl alcohol; benzalkonium chloride; purified water; microcrystalline cellulose; polysorbate 80; carmellose sodium; glycerol; disodium edetate - symptomatic treatment of moderate to severe allergic rhinitis for up to 6 months.

Malta - angličtina - Medicines Authority

meda pharmaceuticals limited - azelastine hydrochloride; fluticasone propionate - nasal spray, suspension - azelastine hydrochloride 137 µg; fluticasone propionate 50 µg - nasal preparations

Malta - angličtina - Medicines Authority

meda pharmaceuticals limited - azelastine hydrochloride; fluticasone propionate - nasal spray, suspension - azelastine hydrochloride 137 µg; fluticasone propionate 50 µg - nasal preparations

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - azelastine hydrochloride 0.5 mg/ml;   - eye drops, solution - 0.5 mg/ml - active: azelastine hydrochloride 0.5 mg/ml   excipient: disodium edetate hypromellose sodium hydroxide sorbitol water for injection - allergic conjunctivitus

Malta - angličtina - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - azelastine hydrochloride, fluticasone propionate - nasal spray, suspension - azelastine hydrochloride 137 µg/spray fluticasone propionate 50 µg/spray - nasal preparations

Malta - angličtina - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - azelastine hydrochloride, fluticasone propionate - nasal spray, suspension - azelastine hydrochloride 137 µg fluticasone propionate 50 µg - nasal preparations