Bélgica - inglés - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - latanoprost 0,5 mg/ml; timolol maleate 6,83 mg/ml - eq. timolol 5 mg/ml - eye drops, solution - 0,005 % - 0,5 % - latanoprost 0.5 mg/ml; timolol maleate 6.83 mg/ml - timolol, combinations

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - latanoprost 0.05 mg/ml; timolol maleate 6.8 mg/ml equivalent to timolol 5 mg/ml - eye drops, solution - 0.05mg/ml, 5mg/ml - active: latanoprost 0.05 mg/ml timolol maleate 6.8 mg/ml equivalent to timolol 5 mg/ml excipient: benzalkonium chloride dibasic sodium phosphate hydrochloric acid monobasic sodium phosphate monohydrate sodium chloride sodium hydroxide water for injection - reduction of intraocular pressure (iop) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. arrow-lattim should not be used to initiate therapy.

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - lantanoprost timolol maleate - eye drops solution - 50 + 5

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - timolol maleate; latanoprost - eye drops - 5mg/1ml ; 50microgram/1ml

Israel - inglés - Ministry of Health

abic marketing ltd, israel - latanoprost; timolol as maleate - eye drops - latanoprost 50 mcg/ml; timolol as maleate 5 mg/ml - timolol - reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers.

Estados Unidos - inglés - NLM (National Library of Medicine)

mwi - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. teratogenic effects: pregnancy category c. reproduction studies have been performed in rats and rabbits. in rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. latanoprost ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether this drug or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when latanoprost ophthalmic solution is administered to a nursing wom

Estados Unidos - inglés - NLM (National Library of Medicine)

direct rx - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution, 0.005% is indicated for the reduction of elevated intraocular pressure in patients with open- angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

Estados Unidos - inglés - NLM (National Library of Medicine)

american regent, inc. - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. teratogenic effects reproduction studies have been performed in rats and rabbits. in rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. latanoprost ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether this drug or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when latanoprost ophthalmic solution is administered to a nursing woman. safety and effectiv

Estados Unidos - inglés - NLM (National Library of Medicine)

sandoz inc - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product. risk summary there are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women to inform drug-associated risks. in animal reproduction studies, intravenous (iv) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see data]. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabbit

Estados Unidos - inglés - NLM (National Library of Medicine)

greenstone llc - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. risk summary there are no adequate and well-controlled studies of latanoprost administration in pregnant women.to inform drug-associated risks. in animal reproduction studies, intravenous (iv) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by iv