Committee for Medicinal Products for Human Use Post-Authorisation Summary of Positive Opinion for Cymbalta

On 26 June 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product Cymbalta. The Marketing Authorisation Holder for this medicinal product is Eli Lilly Nederland B.V.

The CHMP adopted a new indication as follows: ‘‘Treatment of generalised anxiety disorder’’.

Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

For information, the full indications for Cymbalta will be as follows***: ‘‘Treatment of major depressive episodes.

Treatment of diabetic peripheral neuropathic pain in adults.

Treatment of generalised anxiety disorder’’.