Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abbvie sdn bhd - bimatoprost -

Israel - inglês - Ministry of Health

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

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops - excipient ingredients: sodium hydroxide; sodium chloride; hydrochloric acid; water for injections; benzalkonium chloride; citric acid monohydrate; dibasic sodium phosphate heptahydrate - 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.

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

allergan, inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - latisse ® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. latisse ® 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 latisse ® (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 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. in pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. no adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. because animal reproductive studies are not always predictive of human response latisse ®   0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. data animal data in an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). the no observed adverse effect level (noael) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on auc). no abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. in an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). the noael for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). no abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). in a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. these effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. the noael for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). risk summary it is not known whether topical ocular treatment with latisse ®   0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. in animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the recommended human ophthalmic dose (on a mg/m2 basis), however no animal data is available at clinically relevant doses.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for latisse ®   0.03% and any potential adverse effects on the breastfed child from latisse ®  0.03%. use of latisse ®  was evaluated in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. no new safety issues were observed. the results of the global eyelash assessment (gea) are provided in table 1. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

european regulatory affairs t/a ivowen - bimatoprost - eye drops, solution - 0.3 milligram(s)/millilitre - bimatoprost

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

morningside healthcare (malta) limited - bimatoprost - eye drops, solution - bimatoprost

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

allergan, inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - durysta®  (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (iop) in patients with open angle glaucoma (oag) or ocular hypertension (oht). durysta is contraindicated in patients with active or suspected ocular or periocular infections. durysta is contraindicated in patients with corneal endothelial cell dystrophy (e.g., fuchs’ dystrophy) [see warnings and precautions ( 5.1 ) ]. durysta is contraindicated in patients with prior corneal transplantation, or endothelial cell transplants [e.g., descemet’s stripping automated endothelial keratoplasty (dsaek)]. durysta is contraindicated in patients whose posterior lens capsule is absent or ruptured, due to the risk of implant migration into the posterior segment. laser posterior capsulotomy in pseudophakic patients is not a contraindication for durysta use if the intraocular lens fully covers the opening in the posterior capsule. durysta is contraindicated in patients with hypersensitivity to bimatoprost or to any other components of the product [see adverse reactions ( 6.1 ) ]. risk summary there are no adequate and well-controlled studies of durysta (bimatoprost intracameral implant) administration in pregnant women to inform a drug associated risk. oral administration of bimatoprost to pregnant rats and mice throughout organogenesis did not produce adverse maternal or fetal effects at clinically relevant exposures. oral administration of bimatoprost to rats from the start of organogenesis to the end of lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant exposures [see animal data] .  data animal data in an embryofetal development rat study, oral administration of bimatoprost to pregnant rats during organogenesis produced abortion at 0.6 mg/kg/day (1770-times the human systemic exposure to bimatoprost from durysta, based on cmax and a blood-to plasma partition ratio of 0.858). the no observed adverse effect level (noael) for abortion was 0.3 mg/kg/day (estimated at 470-times the human systemic exposure to bimatoprost from durysta, based on cmax ). no fetal abnormalities were observed at doses up to 0.6 mg/kg/day. in an embryofetal development mouse study, oral administration of bimatoprost to pregnant mice during organogenesis produced abortion and early delivery at 0.3 mg/kg/day (2240-times the human systemic exposure to bimatoprost from durysta, based on plasma cmax level; blood-to plasma partition ratio of 0.858). the noael for abortion and early delivery was 0.1 mg/kg/day (400-times the human systemic exposure to bimatoprost from durysta, based on cmax ). no fetal abnormalities were observed at doses up to 0.6 mg/kg/day (5200-times the human systemic exposure to bimatoprost from durysta, based on cmax ). in a pre/postnatal development study, oral administration of bimatoprost to pregnant rats from gestation day 7 through lactation resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at 0.3 mg/kg/day (estimated 470-times the human systemic exposure to bimatoprost from durysta, based plasma cmax and a blood-to plasma partition ratio of 0.858). no adverse effects were observed in rat offspring at 0.1 mg/kg/day (estimated 350-times the human systemic exposure to bimatoprost from durysta, based on plasma cmax ). risk summary there is no information regarding the presence of bimatoprost in human milk, the effects on the breastfed infants, or the effects on milk production. in animal studies, topical bimatoprost has been shown to be excreted in breast milk. because many drugs are excreted in human milk, caution should be exercised when durysta is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for durysta and any potential adverse effects on the breastfed child from durysta. safety and effectiveness of durysta in pediatric patients have not been established. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

União Europeia - inglês - 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.

Cingapura - inglês - HSA (Health Sciences Authority)

abbvie pte. ltd. - bimatoprost; timolol maleate 6.8 mg/ml eqv timolol - solution, sterile - bimatoprost 0.3 mg/ml; timolol maleate 6.8 mg/ml eqv timolol 5 mg/ml

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

allergan malaysia sdn bhd - bimatoprost -