Axsome Therapeutics登记solriamfetol治疗儿童青少年ADHD的III期开放标签长期安全性研究（NCT07773883）
Axsome Therapeutics在ClinicalTrials.gov更新登记NCT07773883：一项III期、多中心、开放标签研究，评估solriamfetol在患ADHD（注意缺陷多动障碍）的儿童青少年中的长期安全性。本次材料仅提供方案描述，未报告招募状态、样本量、主要终点或安全性结果，具体状态以登记库后续提交为准。
#儿科学
ClinicalTrials.gov API v2 · 登记更新
EMA · What's New 儿科学：Human medicines European public assessment report (EPAR): Yorvipath, palopegteriparatide, Date of authorisation: 17/11/2023, Revision: 6, Status: Authorised
原文摘录：Yorvipath RSS Authorised This medicine is authorised for use in the European Union palopegteriparatide Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Yorvipath is a hormone replacement medicine fo … 37 KB - PDF) First published: 15/09/2023 View News on Yorvipath Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 More information on Yorvipath EU/3/20/2350 - orphan designation for treatment of hypoparathyroidism EMA/PE/0000241327 - paediatric investigation plan A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide) - post-authorisation study A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding - post-authorisation study This page was last updated on 06/11/2026
EMA · What's New 儿科学：Human medicines European public assessment report (EPAR): Bylvay, odevixibat, Date of authorisation: 16/07/2021, Revision: 13, Status: Authorised
原文摘录：Bylvay RSS Authorised This medicine is authorised for use in the European Union odevixibat Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Bylvay is a medicine for treating patients from the age of … More information on Bylvay EU/3/12/1028 - orphan designation for treatment of progressive familial intrahepatic cholestasis EU/3/12/1040 - orphan designation for treatment of Alagille syndrome EMEA-002054-PIP01-16-M03 - paediatric investigation plan EMA/PE/0000240317 - paediatric investigation plan Bylvay - withdrawal of application for variation to marketing authorisation Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants with Progressive Familial Intrahepatic Cholestasis (PFIC) who take Odevixibat (Bylvay) - post-authorisation study Prospective Registry-Based Study Evaluating the Effectiveness and Safety of Odevixibat in Participants With Alagille Syndrome (ALGS) - post-authorisation study Prospective Registry-Based Study of the Long-Term Safety of Odevixibat in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) - post-authorisation study This page was last updated on 06/11/2026
WHO · Official News OData 儿科学：WHO at COP31: Health Day opens two weeks of activities to deliver on climate change and health
原文摘录：On Monday, 9 November, health takes centre stage as the thirty-first session of the Conference of the Parties (COP31) to the UN Framework Convention on Climate Change (UNFCCC) opens with a dedicated Health Day. … ATACH and AIR give countries the means to do that, during COP31 and beyond
EMA · News and Safety Reviews精选 儿科学：AMA and EMA issue joint guidance on Ebola vaccine development
原文摘录：Image credit: © peterschreiber.media | stock.adobe.com AMA and EMA issue joint guidance on Ebola vaccine development 23 October 2026 Clinical trial requirements defined for rapid development of Bundibugyo virus vaccines News Human Clinical trials Research … eu All other enquiries Please submit your request via the online form
关注理由：这条儿科学资料涉及临床试验，入组条件、对照设置和研究阶段可以帮助判断结果适用于哪些人群。
EMA · Withdrawn Applications精选 儿科学：Withdrawn application: Kaftrio, 01/09/2026
原文摘录：Kaftrio - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn ivacaftor / tezacaftor / elexacaftor Post-authorisation Human Overview Vert … News on Kaftrio Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026 18/09/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025 28/02/2025 Combination of cystic fibrosis medicines to treat patients with rare mutations 28/02/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021 12/11/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 26/03/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020 26/06/2020 New medicine for cystic fibrosis patients 26/06/2020 More information on Kaftrio Kaftrio This page was last updated on 20/10/2026
关注理由：如果关注儿科学，这条临床试验动态可用于了解研究设计，主要终点和试验阶段建议查看原文。
FDA · MedWatch Safety Alerts精选 儿科学：Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
原文摘录：CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由：这篇儿科学内容涉及具体研究方向，原文中的样本、结局和限制有助于理解其价值。
FDA · MedWatch Safety Alerts精选 儿科学：Early Alert: Cardinal Health Updates Use Instructions for Presource Packs Containing BD Alaris Pump Infusion Sets
原文摘录：CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由：这条儿科学资料涉及具体临床问题，研究人群、方法和结局指标可以结合原文进一步查看。
EMA · Withdrawn Applications精选 儿科学：Withdrawn application: Kalydeco, 01/09/2026
原文摘录：Kalydeco - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn ivacaftor Post-authorisation Human Overview Vertex Pharmaceuticals (Irelan … News on Kalydeco Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026 18/09/2026 Combination of cystic fibrosis medicines to treat patients with rare mutations 28/02/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024 23/02/2024 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021 12/11/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 26/03/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020 18/09/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020 24/07/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020 30/04/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019 18/10/2019 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018 19/10/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018 27/07/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015 25/09/2015 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014 27/06/2014 More information on Kalydeco Kalydeco This page was last updated on 09/10/2026
关注理由：这条儿科学临床试验动态值得跟踪，后续可结合原文核对试验进度、研究设计与结果披露情况。