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

rpk pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 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. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride 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) o

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

rpk pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride ophthalmic solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. azelastine hydrochloride ophthalmic solution, 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.

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: 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 - English - Medicines Authority

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

Malta - English - Medicines Authority

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

Malta - English - 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

Malta - English - 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

New Zealand - English - 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

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

shoreline pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug

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: 6.5 mm, thickness: 3.6 mm