Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Nevanac   
Auth. number : EU/1/07/433
INN : nepafenac
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01B - Antiinflammatory agents
Chemical subgroup: S01BC - Antiinflammatory agents, non-steroids
Chemical substance: S01BC10 - Nepafenac
(See WHO ATC Index)
Indication: NEVANAC is indicated in adults for:
  • Prevention and treatment of postoperative pain and inflammation associated with cataract surgery
  • Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.
Marketing Authorisation Holder: Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

  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
13/12/2007 Centralised - Authorisation EMEA/H/C/818 (2007)6413 of 11/12/2007
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/818/II/1
19/01/2009 Centralised - Notification EMEA/H/C/818/N/2
Updated with Decision(2011)298 of 17/01/2011
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/818/IA/4
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/818/IA/3
17/11/2010 Centralised - Notification EMEA/H/C/818/N/5
Updated with Decision(2011)298 of 17/01/2011
19/01/2011 Centralised - Variation EMEA/H/C/818/II/6 (2011)298 of 17/01/2011
21/01/2011 Centralised - Variation EMEA/H/C/818/IG/39
Updated with Decision(2011)5584 of 27/07/2011
27/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/818/WS/75
29/07/2011 Centralised - Variation (2011)5584 of 27/07/2011
03/01/2012 Centralised - Variation EMEA/H/C/818/II/7/G (2011)10089 of 22/12/2011
26/09/2012 Centralised - Renewal EMEA/H/C/818/R/15 (2012)6844 of 24/09/2012
19/03/2013 Centralised - Variation EMEA/H/C/818/IG/274
Updated with Decision(2014)3813 of 03/06/2014
07/05/2013 Centralised - Variation EMEA/H/C/818/X/16 (2013)2743 of 03/05/2013
14/08/2013 Centralised - Notification EMEA/H/C/818/N/20
Updated with Decision(2014)3813 of 03/06/2014
25/04/2014 Centralised - Variation EMEA/H/C/818/II/22
05/06/2014 Centralised - Yearly update (2014)3813 of 03/06/2014
24/06/2014 Centralised - Notification EMEA/H/C/818/N/26