OZURDEX Intravitreal implant in applicator

Active ingredients: Dexamethasone

Product name and form

OZURDEX 700 micrograms intravitreal implant in applicator.

Pharmaceutical Form

Intravitreal implant in applicator.

Disposable injection device, containing a rod-shaped implant. which is not visible. The implant is approximately 0.46 mm in diameter and 6 mm in length.

Qualitative and quantitative composition

One implant contains 700 micrograms of dexamethasone.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

List of Excipients

Ester terminated 50:50 poly D,L-lactide-co-glycolide
Acid terminated 50:50 poly D,L-lactide-co-glycolide

Pack sizes and marketing

Each pack contains:

One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator.

The applicator consists of a plunger (stainless steel) within a needle where the implant is held in place by a sleeve (silicone). The plunger is controlled by a lever on the side of the applicator body. The needle is protected by a cap and the lever by a safety tab.

The applicator containing the implant is packaged in a sealed foil pouch containing desiccant.

Marketing authorization holder

Allergan Pharmaceuticals Ireland, Castlebar Road, Co. Mayo, Westport, Ireland

Marketing authorization dates and numbers

EU/1/10/638/001

Date of first authorisation: 27/07/2010

Date of latest renewal: 23/03/2015

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom, United States