Novartis (NVS) Receives Positive CHMP Opinion on Expanded Lucentis Indication
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On 13 October 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lucentis. The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd. (NYSE: NVS) .
The CHMP adopted an extension to an existing indication as follows2:
“Lucentis is indicated in adults for:
- The treatment of neovascular (wet) age-related macular degeneration (AMD)
- The treatment of visual impairment due to choroidal neovascularisation (CNV)
- The treatment of visual impairment due to diabetic macular oedema (DME)
- The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
The treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM).”
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion
2 New text in bold, removed text as strikethrough
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