TOBRADEX Eye drops, suspension

Product name and form

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

Pharmaceutical Form

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

List of Excipients

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

Drug
Countries
Austria, Brazil, Canada, Cyprus, Spain, France, Hong Kong, Lithuania, Netherlands, Singapore, United Kingdom, United States