XALATAN Eye drops, solution Ref.[7546] Active ingredients: Latanoprost

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Xalatan 50 micrograms/mL Eye drops, solution.

Pharmaceutical Form

Eye drops, solution.

The solution is a clear, colourless liquid.

Qualitative and quantitative composition

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 F 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
Benzalkonium chloride
Sodium dihydrogen phosphate monohydrate (E339i)
Disodium phosphate anhydrous (E339ii)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 50622/0065

Date of first authorisation: 16 December 1996
Date of latest renewal: 22 November 2015

Drugs

Drug Countries
XALATAN Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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