Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Xalatan 50 micrograms/mL Eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution. The solution is a clear, colourless liquid. |
1 mL Eye drops solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipients with known effect:
Benzalkonium chloride 0.2 mg/mL is included as a preservative.
Sodium dihydrogen phosphate monohydrate (E339i) 7.70 mg/mL.
Disodium phosphate anhydrous (E339ii) 1.55 mg/mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Latanoprost |
The active substance latanoprost, a prostaglandin F2α analogue, is a selective prostanoid FP receptor agonist which reduces the intraocular pressure (IOP) by increasing the outflow of aqueous humour. Reduction of the IOP in man starts about three to four hours after administration and maximum effect is reached after eight to twelve hours. |
| List of Excipients |
|---|
|
Sodium chloride |
Dropper container (5 mL) of polyethylene with a screw cap and tamper evident overcap of polyethylene.
Each dropper container contains 2.5 mL Eye drops, solution corresponding to approximately 80 drops of solution.
Pack sizes: 1 × 2.5 mL, 3 × 2.5 mL, 6 × 2.5 mL.
Not all pack sizes may be marketed.
Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 50622/0065
Date of first authorisation: 16 December 1996
Date of latest renewal: 22 November 2015
| Drug | Countries | |
|---|---|---|
| XALATAN | Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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