Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ozurdex   
Auth. number : EU/1/10/638
Active substance : dexamethasone
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01B - Antiinflammatory agents
Chemical subgroup: S01BA - Corticosteroids, plain
Chemical substance: S01BA01 - Dexamethasone
(See WHO ATC Index)
Indication: 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
• macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see section 5.1)
• inflammation of the posterior segment of the eye presenting as non-infectious uveitis
Marketing Authorisation Holder: Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
28/07/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1140 (2010)5332 of 27/07/2010
01/08/2010 Centralised - Authorisation EMEA/H/C/1140 (2010)5331 of 27/07/2010
14/04/2011 Centralised - Notification EMEA/H/C/1140/N/2
Updated with Decision(2011)4393 of 16/06/2011
14/04/2011 Centralised - Notification EMEA/H/C/1140/N/2
Updated with Decision(2011)8060 of 03/11/2011
20/06/2011 Centralised - Variation EMEA/H/C/1140/II/1 (2011)4408 of 16/06/2011
21/06/2011 Centralised - Variation EMEA/H/C/1140/II/1 (2011)4393 of 16/06/2011
26/07/2011 Centralised - Variation EMEA/H/C/1140/IB/3
07/11/2011 Centralised - Variation EMEA/H/C/1140/II/1 (2011)8060 of 03/11/2011
04/01/2012 Centralised - Variation EMEA/H/C/1140/II/5 (2011)10095 of 22/12/2011
12/09/2012 Centralised - Variation EMEA/H/C/1140/II/6 (2012)6382 of 10/09/2012
08/03/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1140/T/12 (2013)1421 of 06/03/2013
22/05/2013 PSUSA - Modification EMEA/H/C/1140/PSU/9 (2013)2995 of 16/05/2013
27/06/2013 Centralised - Variation EMEA/H/C/1140/II/13
Updated with Decision(2014)4281 of 19/06/2014
23/06/2014 Centralised - Yearly update (2014)4281 of 19/06/2014
28/08/2014 Centralised - 2-Monthly update EMEA/H/C/1140/II/15 (2014)6196 of 26/08/2014
25/03/2015 Centralised - Renewal EMEA/H/C/1140/R/18 (2015)2123 of 23/03/2015