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

alcon laboratories, inc. - netarsudil mesylate (unii: vl756b1k0u) (netarsudil - unii:w6i5qdt7qi), latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dose combination of a rho kinase inhibitor and a prostaglandin f2α analogue indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies of rocklatan ophthalmic solution or its pharmacologically active ingredients (netarsudil and latanoprost) in pregnant women to inform any drug associated risk. however, systemic exposure to netarsudil from ocular administration is low [see clinical pharmacology (12.3) ]. reproduction studies of latanoprost showed embryofetal lethality in rabbits. no embryofetal lethality was observed at a dose approximately 15 times higher than the recommended human ophthalmic dose (rhod). intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures. rocklata

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

alcon laboratories, inc. - netarsudil mesylate (unii: vl756b1k0u) (netarsudil - unii:w6i5qdt7qi) - rhopressa (netarsudil ophthalmic solution) 0.02% 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 rhopressa use in pregnant women to inform any drug associated risk; however, systemic exposure to netarsudil from ocular administration is low [see clinical pharmacology (12.3 )] . intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures [see data] . data animal data netarsudil administered daily by intravenous injection to rats during organogenesis caused abortions and embryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the recommended human ophthalmic dose [rhod], based on cmax ). the no-observed-adverse-effect-level (noael) for embryofetal development toxicity was 0.1 mg/kg/day (40-fold the plasma exposure at the rhod, based on cmax ).

European Union - English - EMA (European Medicines Agency)

santen oy - netarsudil - glaucoma, open-angle; ocular hypertension - ophthalmologicals - reduction of elevated intraocular pressure (iop) in adult patients with primary open-angle glaucoma or ocular hypertension.

European Union - English - EMA (European Medicines Agency)

santen oy - latanoprost, netarsudil mesilate - glaucoma, open-angle; ocular hypertension - ophthalmologicals - roclanda is indicated for the reduction of elevated intraocular pressure (iop) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient iop reduction.

Singapore - English - HSA (Health Sciences Authority)

santen pharmaceutical asia pte. ltd. - netarsudil mesylate eqv netarsudil - solution, sterile - netarsudil mesylate eqv netarsudil 0.02% w/v

Singapore - English - HSA (Health Sciences Authority)

santen pharmaceutical asia pte. ltd. - latanoprost; netarsudil mesylate eqv netarsudil - solution, sterile - latanoprost 0.005% w/v; netarsudil mesylate eqv netarsudil 0.02% w/v

Bangladesh - English - DGDA (Directorate General of Drug Administration)

aristopharma limited - netarsudil - eye drops - 20 mg/100 ml

Bangladesh - English - DGDA (Directorate General of Drug Administration)

popular pharmaceuticals ltd. - netarsudil - eye drops - 20 mg/100 ml

Philippines - English - FDA (Food And Drug Administration)

santen pharmaceutical co. ltd.; importer: santen philippines inc.; distributor: santen philippines inc. - netarsudil (as mesylate) , latanoprost - ophthalmic solution - 200 mcg/50 mcg per ml (0.02%/0.005%)

Bangladesh - English - DGDA (Directorate General of Drug Administration)

aristopharma limited - latanoprost + netarsudil - eye drops - 5 mg + 20 mg/100 ml