Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Eylea   
Auth. number : EU/1/12/797
Active substance : aflibercept
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01L - Ocular vascular disorder agents
Chemical subgroup: S01LA - Antineovascularisation agents
Chemical substance: S01LA05 - Aflibercept
(See WHO ATC Index)
Indication: Eylea is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AMD)
• visual impairment due to macular oedema secondary to central retinal vein occlusion (branch RVO or central RVO)
• visual impairment due to diabetic macular oedema (DME)
• visual impairment due to myopic choroidal neovascularisation (myopic CNV)
Marketing Authorisation Holder: Bayer AG
D-51368 Leverkusen, Deutschland
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
26/11/2012 Centralised - Authorisation EMEA/H/C/2392 (2012)8698 of 22/11/2012
28/08/2013 Centralised - 2-Monthly update EMEA/H/C/2392/II/1 (2013)5599 of 26/08/2013
08/04/2014 Centralised - Notification EMEA/H/C/2392/N/12
Updated with Decision(2014)5785 of 06/08/2014
08/08/2014 Centralised - 2-Monthly update EMEA/H/C/2392/II/9 (2014)5785 of 06/08/2014
28/08/2014 PSUSA - Modification EMEA/H/C/2392/PSUV/11 (2014)6180 of 26/08/2014
26/02/2015 Centralised - 2-Monthly update EMEA/H/C/2392/II/13 (2015)1388 of 24/02/2015
30/10/2015 Centralised - 2-Monthly update EMEA/H/C/2392/II/21 (2015)7599 of 28/10/2015
19/11/2015 Centralised - Variation EMEA/H/C/2392/II/18
Updated with Decision(2016)4244 of 30/06/2016
04/07/2016 Centralised - 2-Monthly update EMEA/H/C/2392/II/27/G (2016)4244 of 30/06/2016
18/08/2016 PSUSA - Modification EMEA/H/C/PSUSA/10020/201511 (2016)5400 of 16/08/2016
07/09/2016 Corrigendum (2016)5400 of 16/08/2016
16/03/2017 Centralised - Variation EMEA/H/C/2392/IAin/35/G
Updated with Decision(2017)2544 of 12/04/2017
19/04/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2392/T/36 (2017)2544 of 12/04/2017
17/07/2017 Centralised - Renewal EMEA/H/C/2392/R/33 (2017)5087 of 13/07/2017
07/09/2017 Centralised - Variation EMEA/H/C/2392/IB/38