Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - bimatoprost - eye drops, solution - bimatoprost 0.3 mg/ml - ophthalmologicals

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - bimatoprost - ophthalmic solution - bimatoprost 0.3 mg / 1 ml - bimatoprost - reduction of elevated intraocular pressure in chronic open angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).

Israel - English - Ministry of Health

teva israel ltd - bimatoprost - ophthalmic solution - bimatoprost 0.3 mg / 1 ml - bimatoprost - reduction of elevated intraocular pressure in chronic open angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).

Australia - English - Department of Health (Therapeutic Goods Administration)

allergan australia pty ltd - timolol maleate; bimatoprost -

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

akorn - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - oxycodone hydrochloride 100 mg in 5 ml - bimatoprost ophthalmic solution 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. bimatoprost ophthalmic solution is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2) ]. risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (auc). these adverse effects were not observed at 2.6 tim

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

apotex corp. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2)] . risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended

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

akorn - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2) ]. risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended

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

gland pharma limited - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2)]. risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recomm

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

alembic pharmaceuticals inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.  bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2) ]. risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogenesis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the

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

somerset therapeutics, llc - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2)] . risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended cl