Questions and answers on the outcome of an extension of indication application for Inovelon (rufinam
The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years. The CHMP considered that the data available at this point in time were not sufficient to recommend this change. However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Inovelon’s product information.