MONOPOST Eye drops, solution Ref.[28017] Active ingredients: Latanoprost

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: LABORATOIRES THEA, 12 RUE LOUIS BLERIOT, 63017 CLERMONT-FERRAND CEDEX 2, France

Product name and form

MONOPOST 50 micrograms/ml eye drops, solution in single-dose container.

Pharmaceutical Form

Eye drops, solution in single-dose container.

The solution is a slightly yellow and opalescent solution.

pH: 6.5–7.5

Osmolality: 250-310 mosmol/kg.

Qualitative and quantitative composition

1 ml eye drops solution contains 50 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

Excipient with known effect: 1 ml eye drops solution contains 50 mg of macrogolglycerol hydroxystearate 40 (castor oil polyoxyl hydrogenated).

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

Macrogolglycerol hydroxystearate 40
Sorbitol
Carbomer 974 P
Macrogol 4000
Disodium edetate
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

5 or 10 single-dose containers (LDPE) containing 0.2 ml of eye drops solution are packed in sachet (copolymers/aluminium/polyethylene/paper or PE/aluminium/polyethylene/PET).

A pack size contains 5 (1x5), 10 (2x5), 10 (1x10), 30 (6x5), 30 (3x10), 90 (18x5) or 90 (9x10) single-dose containers.

Not all pack sizes may be marketed.

Marketing authorization holder

LABORATOIRES THEA, 12 RUE LOUIS BLERIOT, 63017 CLERMONT-FERRAND CEDEX 2, France

Marketing authorization dates and numbers

PL 20162/0015

09/11/2012

Drugs

Drug Countries
MONOPOST Germany, Hong Kong, Ireland, Lithuania, Romania, United Kingdom

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