אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - levocetirizine dihydrochloride - film-coated tablet - 5 milligram(s) - piperazine derivatives; levocetirizine

מלטה - אנגלית - Medicines Authority

clonmel healthcare limited waterford road, clonmel, co. tipperary e91 d768, ireland - levocetirizine dihydrochloride - film-coated tablet - levocetirizine dihydrochloride 5 mg - antihistamines for systemic use

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - brimonidine tartrate, quantity: 2 mg/ml; brinzolamide, quantity: 10 mg/ml - eye drops, suspension - excipient ingredients: propylene glycol; boric acid; mannitol; tyloxapol; sodium chloride; sodium hydroxide; purified water; carbomer 974p; hydrochloric acid; benzalkonium chloride - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction

ארצות הברית - אנגלית - NLM (National Library of Medicine)

alcon laboratories, inc. - brinzolamide (unii: 9451z89515) (brinzolamide - unii:9451z89515), brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brinzolamide 10 mg in 1 ml - simbrinza (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. simbrinza is contraindicated in patients who are hypersensitive to any component of this product. simbrinza is contraindicated in neonates and infants (under the age of two years) [see use in specific populations (8.4)]. developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 60, and 120 times the recommended human ophthalmic dose) produced maternal toxicity at 6 mg/kg/day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than the historic value at 1 and 6 mg/kg. in rats, statistically decreased body weights of fetuses from dams receiving oral doses of 18 mg/kg/day (180 times the recommended

ארצות הברית - אנגלית - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - brinzolamide (unii: 9451z89515) (brinzolamide - unii:9451z89515), brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - simbrinza (brinzolamide and brimonidine tartrate ophthalmic suspension) 1% and 0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha-2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. simbrinza is contraindicated in patients who are hypersensitive to any component of this product. simbrinza is contraindicated in neonates and infants (under the age of two years) [see use in specific populations (8.4)] . pregnancy category c: developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 60, and 120 times the recommended human ophthalmic dose) produced maternal toxicity at 6 mg/kg/day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than the historic value at 1 and 6 mg/kg. in rats, statistically decreased body weights of fetuses from dams receiving oral doses of 18 mg/k

ישראל - אנגלית - Ministry of Health

novartis israel ltd - brimonidine tartrate; brinzolamide - eye drops, suspension - brimonidine tartrate 2 mg/ml; brinzolamide 10 mg/ml - brinzolamide, combinations - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction.

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

novartis europharm limited - brinzolamide, brimonidine tartrate - ocular hypertension; glaucoma, open-angle - ophthalmologicals - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction.

ישראל - אנגלית - Ministry of Health

novartis israel ltd - brimonidine tartrate; brinzolamide - eye drops suspension - brimonidine tartrate 2 mg / 1 ml; brinzolamide 10 mg / 1 ml - brinzolamide, combinations - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - brimonidine tartrate 2 mg/ml;  ; brinzolamide 10 mg/ml;   - eye drops, suspension - 1%/0.2% - active: brimonidine tartrate 2 mg/ml   brinzolamide 10 mg/ml   excipient: benzalkonium chloride boric acid carbomer 974 hydrochloric acid mannitol propylene glycol purified water sodium chloride sodium hydroxide tyloxapol - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction.