Ozurdex

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dexamethasone

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

Overview

This is a summary of the European public assessment report (EPAR) for Ozurdex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ozurdex.

This EPAR was last updated on 11/12/2018

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
10
Date of issue of marketing authorisation valid throughout the European Union
26/07/2010
Contact address
Castlebar Road
Westport, Co Mayo
Ireland

Product information

20/11/2018 Ozurdex - EMEA/H/C/001140 - PSUSA/00000985/201801

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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