Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SOLUTION, STERILE
**Posology and method of administration** Posology The recommended dose is one drop in the affected eye(s) once daily in the evening. If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. _Paediatric population_ The safety and efficacy of omidenepag isopropyl in children and adolescents have not yet been established. No data are available. Method of administration For ocular use. Be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart. Benzalkonium chloride may change the colour of the contact lenses. Contact lens wearers should remove the contact lenses before using this product and put them back after 5–10 minutes.
OPHTHALMIC
Medical Information
**Therapeutic indications** Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
**Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in ‘Description’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Patients with aphakic eyes or intraocular lens (IOL) inserted eyes (see ‘Undesirable effects’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant use with tafluprost (see ‘Interactions’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
S01EX06
omidenepag
Manufacturer Information
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Santen Pharmaceutical Co., Ltd. Shiga Plant
Active Ingredients
Documents
Package Inserts
EYBELIS Ophthalmic Solution PI.pdf
Approved: September 30, 2022