European Union - English - EMA (European Medicines Agency)

allergan pharmaceuticals ireland - bimatoprost, timolol - glaucoma, open-angle, ocular hypertension - ophthalmologicals, - reduction of intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

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

sandoz pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops - excipient ingredients: sodium hydroxide; benzalkonium chloride; citric acid monohydrate; hydrochloric acid; dibasic sodium phosphate heptahydrate; purified water; sodium chloride - bimatoprost eye drops are indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

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

sandoz inc - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.3 mg in 1 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 time

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

lupin limited - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.3 mg in 1 ml - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. none teratogenic effects:   in embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 33 or 97 times, respectively, the maximum intended human exposure based on blood auc levels. at doses at least 41 times the maximum intended human exposure based on blood auc levels, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup body weights were reduced. there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. because animal reproductive studies are not always predictive of human response. bimatoprost ophthalmic solution, 0.03% should be administered during pregnancy only if the potential benefit justifies the

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

lupin pharmaceuticals, inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.3 mg in 1 ml - 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

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - bimatoprost 0.1 mg/ml;   - eye drops, solution - 0.1 mg/ml - active: bimatoprost 0.1 mg/ml   excipient: benzalkonium chloride citric acid monohydrate dibasic sodium phosphate heptahydrate hydrochloric acid sodium chloride sodium hydroxide water for injection - bimatoprost actavis is indicated as monotherapy for the reduction of elevated intraocular pressure (iop) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - bimatoprost 0.3 mg/ml;   - eye drops, solution - 0.3 mg/ml - active: bimatoprost 0.3 mg/ml   excipient: benzalkonium chloride citric acid monohydrate dibasic sodium phosphate heptahydrate hydrochloric acid sodium chloride sodium hydroxide water for injection - bimatoprost actavis is indicated as monotherapy for the reduction of elevated intraocular pressure (iop) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents.

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

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide; citric acid monohydrate; sodium chloride; dibasic sodium phosphate heptahydrate; benzalkonium chloride - bimatoprost is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

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

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; citric acid monohydrate; water for injections; sodium hydroxide; hydrochloric acid; benzalkonium chloride - bimatoprost is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

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

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; dibasic sodium phosphate heptahydrate; citric acid monohydrate; water for injections; sodium chloride; benzalkonium chloride - bimatoprost is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.