FML Eye drops, suspension Ref.[8103] Active ingredients: Fluorometholone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Allergan Limited, Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK

Product name and form

FML Liquifilm Ophthalmic 1 mg/ml eye drops, suspension.

Pharmaceutical Form

Eye drops, suspension.

A white, microfine suspension.

Qualitative and quantitative composition

One millilitre contains 1 mg Fluorometholone.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Fluorometholone

Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation. Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and scarring.

List of Excipients

Polyvinyl alcohol
Benzalkonium chloride
Edetate disodium
Sodium chloride
Disodium phosphate, heptahydrate
Sodium dihydrogen phosphate, monohydrate
Polysorbate 80
Sodium hydroxide (for pH adjustment)
Purified water

Pack sizes and marketing

A bottle and an applicator tip of low density polyethylene (LDPE). A screw cap of polystyrene (MIPS).

The bottle contains 5 ml or 10 ml of suspension.

Not all pack sizes may be marketed.

Marketing authorization holder

Allergan Limited, Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK

Marketing authorization dates and numbers

PL 00426/0028

15th July 2003

Drugs

Drug Countries
FML Australia, Finland, Hong Kong, Ireland, Israel, Netherlands, New Zealand, Singapore, Turkey, United Kingdom, United States, South Africa

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