Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
Yellox 0.9 mg/ml eye drops solution.
Eye drops, solution.
Clear yellow solution.
pH: 8.1-8.5; osmolality: 270-330 mOsmol/kg
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.
Sodium sulphite, anhydrous (E221)
Water for injections
Sodium hydroxide (for pH adjustment)
5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap.
Pack of 1 bottle.
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
Date of first authorisation: 18.05.2011
Date of latest renewal: 11.01.2016
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