Nevanac

RSS

nepafenac

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 03/09/2018

Authorisation details

Product details
Name
Nevanac
Agency product number
EMEA/H/C/000818
Active substance
nepafenac
International non-proprietary name (INN) or common name
nepafenac
Therapeutic area (MeSH)
  • Pain, Postoperative
  • Ophthalmologic Surgical Procedures
Anatomical therapeutic chemical (ATC) code
S01BC10
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
11/12/2007
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

23/08/2018 Nevanac - EMEA/H/C/000818 - IA/0038

Contents

  • 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.

Pharmacotherapeutic group

OPHTHALMOLOGICALS

Therapeutic indication

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.

Assessment history

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