This is a summary of the European public assessment report (EPAR) for Nevanac. 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 Nevanac.
Nevanac : EPAR - Summary for the public (PDF/72.99 KB)
First published: 14/01/2008
Last updated: 09/09/2016
Nevanac : EPAR - Risk-management-plan summary (PDF/47.29 KB)
First published: 06/07/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
23/08/2018 Nevanac - EMEA/H/C/000818 - IB/0047
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Nevanac is indicated 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.