Ozurdex

RSS

dexamethasone

Authorised
This medicine is authorised for use in the European Union.

Overview

Ozurdex is an implant that is injected into the eye.

It is used to treat adults with impaired vision due to macular oedema associated with:

  • blockage of the veins carrying blood from the back of the eye;
  • damage to blood vessels caused by diabetes in patients who have an artificial lens in their eye or in whom other treatment did not work or was unsuitable.

Macular oedema is swelling in the macula, the central part of the retina (the light-sensing layer at the back of the eye), which can reduce the central part of a person’s vision and affect tasks such as reading and driving.

Ozurdex is also used to treat adults with non-infectious uveitis at the back of the eye. Uveitis is inflammation of the uvea, the middle layer of the eye.

This EPAR was last updated on 26/11/2019

Authorisation details

Product details
Name
Ozurdex
Agency product number
EMEA/H/C/001140
Active substance
dexamethasone
International non-proprietary name (INN) or common name
dexamethasone
Therapeutic area (MeSH)
  • Macular Edema
  • Uveitis
Anatomical therapeutic chemical (ATC) code
S01BA01
Publication details
Marketing-authorisation holder
Allergan Pharmaceuticals Ireland
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
26/07/2010
Contact address
Castlebar Road
Westport, Co Mayo
Ireland

Product information

05/09/2019 Ozurdex - EMEA/H/C/001140 - II/0035

Contents

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Pharmacotherapeutic group

  • Ophthalmologicals

  • OTHER OPHTHALMOLOGICALS

Therapeutic indication

Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).

Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.

Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.

Assessment history

Changes since initial authorisation of medicine

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