欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Sapropterin Dipharma
适用类别Human
治疗领域Phenylketonurias
通用名/非专利名称sapropterin
活性成分Sapropterin dihydrochloride
产品号EMEA/H/C/005646
患者安全信息no
授权状态Authorised
ATC编码A16AX07
是否额外监管no
是否仿制药yes
是否生物类似药no
是否附条件批准no
是否特殊情形no
是否加速审评no
是否罕用药no
批准上市日期2022/02/16
上市许可持有人/公司名称Dipharma Arzneimittel GmbH
人用药物治疗分组Other alimentary tract and metabolism products,
审评意见发布日期2021/12/16
决定日期2023/01/30
修订号3
适应症Sapropterin Dipharma is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment.Sapropterin Dipharma is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
首次发布日期2021/12/14
修订日期2023/02/20
产品信息https://www.ema.europa.eu/en/documents/product-information/sapropterin-dipharma-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/sapropterin-dipharma
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