11月3日——奇耶斯全球罕见疾病公司请求欧洲药品管理局(EMA)药物评审委员会(CHMP)对其提出的每四周给药2 mg/kg的Elfabrio方案的负面意见进行重新审查。奇耶斯全球罕见疾病公司和Protalix BioTherapeutics正在向EMA申请重新审查Elfabrio(Pegunigalsidase Alfa)在欧盟的替代给药方案的负面意见。目前Elfabrio的现有市场授权仍然有效。
11月3日——奇耶斯全球罕见疾病公司请求欧洲药品管理局(EMA)药物评审委员会(CHMP)对其提出的每四周给药2 mg/kg的Elfabrio方案的负面意见进行重新审查。奇耶斯全球罕见疾病公司和Protalix BioTherapeutics正在向EMA申请重新审查Elfabrio(Pegunigalsidase Alfa)在欧盟的替代给药方案的负面意见。目前Elfabrio的现有市场授权仍然有效。
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