YELLOX Eye drops, solution Ref.[6639] Active ingredients: Bromfenac

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Product name and form

Yellox 0.9 mg/ml eye drops solution.

Pharmaceutical Form

Eye drops, solution.

Clear yellow solution.

pH: 8.1-8.5; osmolality: 270-330 mOsmol/kg

Qualitative and quantitative composition

1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate).

One drop contains approximately 33 micrograms bromfenac.

Excipient(s) with known effect: Each ml of solution contains 50 micrograms of benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient
Description
Bromfenac
List of Excipients

Boric acid
Borax
Sodium sulphite, anhydrous (E221)
Tyloxapol
Povidone (K30)
Benzalkonium chloride
Disodium edetate
Water for injections
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap.

Pack of 1 bottle.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Marketing authorization dates and numbers

EU/1/11/692/001

Date of first authorisation: 18.05.2011
Date of latest renewal: 11.01.2016

Drugs

Drug
Countries
YELLOX
Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom
 
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