TOBRADEX Eye drops, suspension

Product name and form

TOBRADEX 3mg/ml/1mg/ml Eye Drops, Suspension.

Eye Drops, Suspension.

White to off-white suspension.

Qualitative and quantitative composition

Each ml contains: Tobramycin 3mg, Dexamethasone 1mg.

For full list of excipients, see section 6.1

Disodium edetate
Hydroxyethylcellulose
Benzalkonium chloride
Purified water
Sodium chloride
Sodium sulphate anhydrous
Sulphuric acid for pH adjustment and / or
Sodium hydroxide for pH adjustment
Tyloxapol

Pack sizes and marketing

5ml dropper container (LDPE) and screw cap (polypropylene).

Pack size: 1 × 5ml.

Marketing authorization holder

Alcon Laboratories UK, Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 00649/0119

31/01/2001 / 30/04/2010

Drugs

TOBRADEX

Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States, South Africa

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