1 February 2012 Committee for Medicinal Products for Human Use (CHMP) Assessment report Nevanac nepafenac Procedure No.: EMEA/H/C/000818/II/0007/G Note Variation assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail
[email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. 1. Background information on the procedure 1.1. Requested Type II Group of variations Pursuant to Article 16 for single and 7.2.(b) for grouped of Commission Regulation (EC) No 1234/2008, Alcon Laboratories (UK) Ltd. submitted to the European Medicines Agency on 4 January 2011 an application for a group of variations. This application concerns the following medicinal product: Medicinal product: International non-proprietary name: Presentations: Nevanac Nepafenac See Annex A The following variations were requested in the group: Variation(s) requested Type C.I.6 Change(s) to therapeutic indication II a) Addition of a new therapeutic indication or modification of an approved one. C.I.4 Variations related to significant modifications of the Summary of Product Characteristics due in particular to II new quality, pre-clinical,clinical or pharmacovigilance data. The requested group of variations proposed amendments to the Summary of Product Characteristics (SmPC) and Package Leaflet. With this application the MAH proposed to add the following indication: “prevention of postoperative macular oedema associated with cataract surgery” with consequential changes to sections 4.1, 4.2, 4.8 and 5.1 of the SmPC.