The European Public Assessment Report (EPAR) for Fubelv with the active substance etanercept has an opinion status.[1] The report concerns the evaluation of pediatric use studies according to Article 46 of Regulation (EC) no. 1901/2006.[1] A long-term study 20021618 showed that the safety profile of etanercept in pediatric patients is consistent with the already known profile.[1] Of the five pediatric subjects who were withdrawn from the study, one due to worsening of JRA, one due to purpura fulminans, one due to skin disease and fibro tendonitis, and one due to infection.[1] Data submitted under Article 46 are considered satisfactory and do not require changes to the Summary of Product Characteristics (SPC).[1] The benefit-risk ratio for etanercept remains positive without change.[1] Post-authorization commitments (PACs) are met with one open question.[1]