OCUFEN Eye drops, solution Ref.[8116] Active ingredients: Flurbiprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK

Product name and form

Ocufen.

Pharmaceutical Form

Eye drops, solution.

Qualitative and quantitative composition

Flurbiprofen sodium 0.03% w/v.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Flurbiprofen

Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition of prostaglandin synthesis. In humans flurbiprofen has potent analgesic, antipyretic and anti-inflammatory properties.
List of Excipients

Liquifilm (polyvinyl alcohol)
Potassium chloride
Sodium chloride
Sodium citrate dihydrate
Citric acid monohydrate
Sodium hydroxide or
Hydrochloric acid (for pH-adjustment)
Purified water

Pack sizes and marketing

Clear, plastic unit dose vial, each containing 0.4 ml of solution.

Marketing authorization holder

AbbVie Ltd., Maidenhead, SL6 4UB, UK

Marketing authorization dates and numbers

PL 41042/0072

28th June 1991 / 17th May 2005

Drugs

Drug Countries
OCUFEN Brazil, France, United Kingdom
 
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