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INTRODUCTION Drug Substance Bimatoprost

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Bimatoprost-Timolol/Pharmathen 0.3mg/mL + 5mg/mL, Preservative Free, Eye drops solution, multidose container 2.3 Quality Overall Summary, p.1

2.3 Quality Overall Summary

INTRODUCTION

Drug Substance Bimatoprost

Drug Substance Proprietary name: Bimatoprost

Drug Substance Non-proprietary name (INN): Bimatoprost

Drug Substance Common name: Bimatoprost Drug Substance Timolol Maleate

Drug Substance Proprietary name: Timolol Maleate

Drug Substance Non-proprietary name (INN): Timolol Maleate

Drug Substance Common name: Timolol Drug Product

Drug Product Manufacturer: EXCELVISION.

Drug Product Dosage Forms: Preservative free Eyes, drops solution

Strengths: Bimatoprost 0.3 mg/mL Timolol 5 mg/mL

Route of administration: Topical

Proposed indication: Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

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