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HSA Approval

RHOPRESSA OPHTHALMIC SOLUTION, 0.02% w/v

SIN16816P

RHOPRESSA OPHTHALMIC SOLUTION, 0.02% w/v

RHOPRESSA OPHTHALMIC SOLUTION, 0.02% w/v

July 4, 2023

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Regulatory Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**2\. DOSAGE AND ADMINISTRATION** The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. Twice a day dosing is not well tolerated and is not recommended. If RHOPRESSA is to be used concomitantly with other topical ophthalmic drug products to lower IOP, administer each drug product at least 5 minutes apart. Due to netarsudil’s vasodilating properties, other eye drops should be administered before netarsudil. Eye ointments should be administered last.

OPHTHALMIC

Medical Information

**1\. INDICATIONS AND USAGE** RHOPRESSA (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension _\[see section 12 Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.

**4\. CONTRAINDICATIONS** Hypersensitivity to the active substance or to any of the excipients.

S01EX05

netarsudil

Manufacturer Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Aerie Pharmaceuticals Ireland Limited

Active Ingredients

Netarsudil mesylate eqv Netarsudil

0.02% w/v

Netarsudil

Documents

Package Inserts

Rhopressa Ophthalmic solution PI.pdf

Approved: July 4, 2023

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