CHMP recommends extension of peginterferon alfa-2a (Pegasys®) license to include use in hepatitis C treatment from 5 years of age

Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a new indication for peginterferon alfa-2a (Pegasys®), as follows:   "Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents 5 years of age and older, who are positive for serum HCV-RNA. When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis."   The CHMP also issued a positive opinion regarding the addition of a new strength (90 mcg) of Pegasys® to the existing product range.   Detailed conditions 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 ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news