ILUVIEN Intravitreal implant Ref.[7965] Active ingredients: Fluocinolone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Alimera Sciences Limited, Royal Pavilion, Wellesley Road, Aldershot, Hampshire, GU11 1PZ, United Kingdom

Product name and form

ILUVIEN 190 micrograms intravitreal implant in applicator.

Pharmaceutical Form

Intravitreal implant in applicator.

Light brown coloured cylinder, approximately 3.5mm x 0.37mm in size.

Implant applicator with 25 gauge needle.

Qualitative and quantitative composition

Each implant contains 190 micrograms of fluocinolone acetonide.

For a full list of excipients, see Section 6.1.

Active Ingredient Description
Fluocinolone

Fluocinolone acetonide is a synthetic fluorinated corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.

List of Excipients

Polyvinyl alcohol
Polyimide tube
Silicone adhesive

Pack sizes and marketing

The implant is supplied in a single use applicator with a 25 gauge needle. Each sterile applicator contains a light brown 3.5 mm long cylindrical implant. The applicator is packaged in a plastic tray sealed with a lid.

Marketing authorization holder

Alimera Sciences Limited, Royal Pavilion, Wellesley Road, Aldershot, Hampshire, GU11 1PZ, United Kingdom

Marketing authorization dates and numbers

PL 41472/0001

04/05/2012

Drugs

Drug Countries
ILUVIEN Austria, Spain, Finland, France, Ireland, Netherlands, New Zealand, Poland, United Kingdom, United States

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