Ozurdex (dexamethasone)
- Region
- 🇪🇺 EU
- Active substance
- dexamethasone
- Company
- AbbVie Deutschland GmbH & Co. KG
- Status
- Authorised
- Therapeutic area
- Macular Edema; Uveitis
- CHMP opinion
- Thu 20 May 2010
- EU approval
- Mon 26 Jul 2010
- Application
- EMEA/H/C/001140
- ATC
- S01BA01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Neofordex Authorised · THERAVIA
- 🇪🇺 Dexamethasone Taw Application withdrawn · Taw Pharma (Ireland) Ltd
- 🇪🇺 Neofordex Application withdrawn · Laboratoires CTRS - Boulogne Billancourt
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.