This submission is a safety review labeling supplement for antihemophilic factor (Recombinant), single chain (rVIII single chain) licensed in 2016 for the treatment of adults and children with hemophilia A for on demand treatment and control of bleeding episodes, routine prophylaxis to reduce frequency of bleeding episodes, and perioperative management of bleeding.申请人从研究CSL627_3001的ARM 2(PUP)提交的数据,以支持将有关PUP处理的信息添加到包装插入物中的建议。该机构已经在研究CSL627_3001 ARM 1和3的先前治疗患者(PTP)的初步批准的Afstyla批准并审查此PAS标记补充剂的疗效数据的审查是不必要的,鉴于对Afstyla
品牌名称genic名称adamimumab-adbm(cf)pen adamimumab-adbm adlimumab-fkjp(cf)adamimumab-fkjp adallimab-fkjp(cf)pen adbkjp adbkjp adbkjp adbryumbryumbryab-dtrmdab-dtrmdab-dtrmdab-dtrmdab-dcjp布伦毒蛋白vedotin adcirca tadalafil adempas riociguat adrimycin adribiubicin hcl adrucil fuororouracilacilacilacilacilacilacilacilacilacilacialacialacialacialacialacialacialacialacialacialacialacibamab-avwa向抗imophil.fviiiii ad Adynoviii danynovate antynovate antiynovate antihemoi.fviiii.fviii, Disperz verolymus afstyla antihem.fviii,sin-chn,b-dm tram autovig autoinjector Ereumab-aooe Ajovy Freezumab-Vrm Ajovy Autoinjector Fremanezumab-Vffrm akeegae Alduathaseasee auturarib-Vrm Alectinib HCl Alferon n Interferon alfa-n3 alimta potetrexed disodium aliqopa copanlib di-hcl Alkeran alkeran melphaan melphalan melphalan melphalan melphalan melphalan hlphaan hcl alphanate抗孕妇抗孕妇抗孕妇抗孕酸抗孕妇抗雌激素/vwfαααα-ααα- rec,fc-vwf-xten,bddddddddl unbriginbarginib alviz altrombopag胆碱