Ireland - English - HPRA (Health Products Regulatory Authority)

meda health sales ireland limited - azelastine hydrochloride fluticasone propionate - nasal spray suspension - 137/50 mcg/acutuation

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

viatris uk healthcare ltd - fluticasone propionate; azelastine hydrochloride - spray - 50microgram/1dose ; 137microgram/1dose

Malta - English - Medicines Authority

jv healthcare limited navi buidlings, pantar road, lija, lja 2021, malta - nasal spray, suspension - azelastine hydrochloride 137 µg/spray fluticasone propionate 50 µg/spray - nasal preparations

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

meda pharma gmbh & co. kg - azelastine(azelastine hydrochloride), fluticasone (fluticasone propionate) - spray nasal (suspension) - 137mcg/dose+ 50mcg/dose

Canada - English - Health Canada

bgp pharma ulc - fluticasone propionate; azelastine hydrochloride - spray, metered dose - 50mcg; 137mcg - fluticasone propionate 50mcg; azelastine hydrochloride 137mcg - antiallergic agents

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

apotex corp. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 0.5 mg in 1 ml - azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.

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

upsher-smith laboratories, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug in 0.137 ml - 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. pregnancy category c there are no adequate and well-controlled clinical studies in pregnant women. azelastine hydrochloride has been shown to cause developmental toxicity in mice, rats, and rabbits. azelastine hydrochloride nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. teratogenic effects in mice, azelastine hydrochloride caused embryo-fetal death, malformations (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 170 times the maximum recommended human daily intranasal dose (mrhdid) in adults (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day, which also caused mater

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

padagis israel pharmaceuticals ltd - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 205.5 ug - azelastine hcl nasal spray, 0.15% is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age 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 4 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 180 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.644 mg. however, the relevance of these findings in animals to pregn

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

apotex corp. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 205.5 ug - azelastine hydrochloride nasal spray, 0.15% is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride nasal spray 0.15% 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 4 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 180 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.644 mg. however, the relevance of these

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

breckenridge pharmaceutical, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug in 0.137 ml - 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) of 1.096