RHOKIINSA Eye drops, solution Ref.[49924] Active ingredients: Netarsudil

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Aerie Pharmaceuticals Ireland, Limited, Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, Ireland

Product name and form

Rhokiinsa 200 micrograms/ml eye drops, solution.

Pharmaceutical Form

Eye drops, solution (eye drops).

Clear solution, pH 5 (approximately).

Qualitative and quantitative composition

Each ml of solution contains 200 micrograms netarsudil (as mesylate).

Excipient(s) with known effect: Each ml of solution contains 150 micrograms benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Netarsudil

Netarsudil, a Rho kinase inhibitor, is believed to reduce intraocular pressure (IOP) by increasing outflow of aqueous humor. Studies in animal and man suggest that the main mechanism of action is increased trabecular outflow. These studies also suggest that netarsudil lowers IOP by reducing episcleral venous pressure.

List of Excipients

Benzalkonium chloride
Mannitol
Boric acid
Sodium hydroxide (for pH-adjustment)
Water for injections

Pack sizes and marketing

Rhokiinsa is supplied sterile in opaque white low density polyethylene bottles (2.5 ml fill in a 4 ml container) and tips with white polypropylene caps and anti-tamper seals.

Carton containing 1 bottle.

Marketing authorization holder

Aerie Pharmaceuticals Ireland, Limited, Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, Ireland

Marketing authorization dates and numbers

EU/1/19/1400/001

Drugs

Drug Countries
RHOKIINSA Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland

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