VEXOL Eye drops, suspension Ref.[9456] Active ingredients: Rimexolone

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2005 Publisher: Alcon Laboratories (UK) Limited, Pentagon Park, Boundary Way Hemel Hempstead, Hertfordshire, HP2 7UD, United Kingdom

Product name and form

VEXOL 1% (10 mg/ml) eye drops, suspension.

Pharmaceutical Form
Eye drops, suspension. Vexol is a white to off-white suspension.

Qualitative and quantitative composition

Rimexolone 10 mg/ml.

For excipients, see section 6.1.

Active Ingredient	Description
Rimexolone	Rimexolone is a corticosteroid drug. Placebo controlled clinical studies demonstrated that rimexolone is efficacious for the treatment of anterior chamber inflammation following cataract surgery.

List of Excipients
Benzalkonium chloride Mannitol Carbomer Polysorbate 80 Sodium chloride Disodium edetate Sodium hydroxide and/or hydrochloric acid Purified water

Pack sizes and marketing

Low density polyethylene bottles (droptainer) containing 3 mL, 5 mL, or 10 mL and with polypropylene screw caps.

Not all pack sizes may be marketed.

Marketing authorization holder

Alcon Laboratories (UK) Limited, Pentagon Park, Boundary Way Hemel Hempstead, Hertfordshire, HP2 7UD, United Kingdom

Marketing authorization dates and numbers

PL 00649/0136

19 July 1995/19^th July 2000 (to be amended to 19^th July 2005 on approval of MRP renewal application)

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