Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

santen pharma malaysia sdn. bhd. - diquafosol sodium -

Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

santen pharma malaysia sdn. bhd. - timolol maleate; dorzolamide hcl -

Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

santen pharma malaysia sdn. bhd. - ofloxacin -

Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

santen pharma malaysia sdn. bhd. - levofloxacin -

Singapore - engleză - HSA (Health Sciences Authority)

santen pharmaceutical asia pte. ltd. - omidenepag isopropyl - solution, sterile - omidenepag isopropyl 0.02 mg/ml

Canada - engleză - Health Canada

santen incorporated - cyclosporine - emulsion - 0.1% - cyclosporine 0.1% - anti-inflammatory agents, miscellaneous

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

santen incorporated - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (vkc) in children and adults. none risk summary there are no adequate and well-controlled studies of verkazia administration in pregnant women to inform a drug-associated risk. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see data ] . data animal data oral administration of cyclosporine oral solution (usp) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body weight) were approximately 320 and 2150 times higher than the daily maximum recommended human ophthalmic dose (mrhod) of 0.015 mg/kg/day, respectively. no adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

santen incorporated - omidenepag isopropyl (unii: g0g0h52u6k) (omidenepag - unii:z95f9f9lu4) - omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no available data on the use of omlonti in pregnant women. in animal reproduction studies, subcutaneous administration of omidenepag isopropyl to pregnant rabbits throughout the period of organogenesis produced fetal skeletal anomalies at a dose of 24 times the clinical dose, based on estimated plasma c max . omidenepag isopropyl was not teratogenic in rats when administered subcutaneously at 1 mg/kg/day, 2,452 times the clinical dose, based on estimated plasma c max (see data) . data animal data an embryofetal development study was conducted in pregnant rabbits administered omidenepag isopropyl once daily by subcutaneous injection at 0.008, 0.08, or 0.8 mg/kg/day from gestation day 6 to 18, a period which covers implantation

Malta - engleză - Medicines Authority

santen oy niittyhaankatu 20, 33720 tampere, finland - timolol, tafluprost - eye drops, solution - timolol 5 mg tafluprost 15 µg - ophthalmologicals

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

santen oy - timolol maleate - eye drops, solution - 0.25 %w/v - reduction of elevated intra-ocular pressure in various conditions including the following: patients with ocular hypertension; patients with chronic open-angle glaucoma including aphakic patients; some patients with secondary glaucoma.