Novo Nordisk (NVO) Receives positive CHMP Opinion for NovoRapid Marketing Adjustment

September 16, 2016 8:30 AM EDT
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On 15 September 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 NovoRapid. The marketing authorisation holder for this medicinal product is Novo Nordisk A/S (NYSE: NVO).

The CHMP adopted an extension to the existing indication as follows2:

“NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 2 years and above.”

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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