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Koselugo (selumetinib)
申请企业
ASTRAZENECA PHARMACEUTICALS LP
药品名称
Koselugo (selumetinib)
承诺描述
Characterize and evaluate the long-term safety effects and any potential for specific serious adverse risks of selumetinib in pediatric patients. Submit the complete final report and long-term follow-up safety data (minimum of 7 years) from pediatric patients enrolled on SPRINT and all other ongoing or completed studies of selumetinib to include an analysis of the following toxicities in pediatric patients: ocular toxicity (including but not limited to retinal pigment epithelial detachment and retinal vein occlusion), cardiac toxicity (including but not limited to ventricular dysfunction), muscle toxicity (including but not limited to rhabdomyolysis and symptomatic and asymptomatic CPK elevation), serious gastrointestinal toxicity (including but not limited to colitis, ileus, intestinal obstruction, and intestinal perforation), and serious dermatologic toxicity.