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LUMIGAN Eye drops, solution (2019)

Active ingredients: Bimatoprost

Product Name and Form

LUMIGAN 0.1 mg/ml eye drops, solution.

Pharmaceutical form

Eye drops, solution.

Colourless solution.

Qualitative and Quantitative Composition

One ml of solution contains 0.1 mg bimatoprost.

Excipient with known effect: One ml of solution contains 0.2 mg benzalkonium chloride.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Bimatoprost

Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to prostaglandin F (PGF), that does not act through any known prostaglandin receptors.

List of excipients

Benzalkonium chloride
Sodium chloride
Sodium phosphate dibasic heptahydrate
Citric acid monohydrate
Hydrochloric acid or sodium hydroxide (to adjust pH)
Purified water

Pack sizes and Marketing

White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution. Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co. Mayo, Ireland

07 January 2010

Marketing authorization number:

EU/1/02/205/003-004