上市许可-话题@MedSci

#上市许可#

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上市许可

2020-05-29

xinxin088 (审核中...)

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#上市许可#

尘螨变应原舌下片ACARIZAX® 豁免中国注册临床试验，2022年将提交上市许可申请

2022-05-05

xinxin088 (审核中...)

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#上市许可#

武田的Exkivity (mobocertinib) 获得英国MHRA有条件上市许可，用于治疗罕见非小细胞肺癌

2022-07-29

xinxin088 (审核中...)

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#上市许可#

EMA 收到molnupiravir的上市许可申请

2022-05-20

xinxin088 (审核中...)

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#上市许可#

海和药物紫杉醇口服溶液（RMX3001）中国上市许可申请获正式受理

2023-02-06

xinxin088 (审核中...)

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#上市许可#

再迎出海里程碑，百泽安®肺癌和食管癌上市许可申请获欧洲药品管理局受理

2022-10-08

xinxin088 (审核中...)

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#上市许可#

CDE新增14条常见一般性技术问题解答：化学药品仿制药能否直接申报上市许可申请？

2021-06-25

xinxin088 (审核中...)

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#上市许可#

Leber遗传性视神经病变基因治疗药物LUMEVOQ提交上市许可申请

2021-08-10

xinxin088 (审核中...)

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#上市许可#

Myovant Sciences向欧洲药品管理局提交了Relugolix联合片剂治疗子宫肌瘤的上市许可申请

2020-07-06

智慧医人 (审核中...)

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#上市许可#

12月1日起，全面实施药品上市许可持有人制度，临床试验机构备案管理，取消药品GMP、GSP认证

2020-05-31

xinxin088 (审核中...)

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#上市许可#

药品上市许可人制度助力阿尔茨海默病创新药获批

2019-11-25

xinxin088 (审核中...)

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#上市许可#

NMPA授予Tagrisso（osimertinib）上市许可，治疗EGFR突变的非小细胞肺癌

2019-12-18

xinxin088 (审核中...)

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#上市许可#

国家药监局：药品上市许可持有人数据库上线，公众可官网检索

2020-06-30

xinxin088 (审核中...)

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#上市许可#

欧盟决定保留羟乙基淀粉注射液上市许可并给出了这些建议

2019-09-06

xinxin088 (审核中...)

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#上市许可#

Bluebirdβ-地中海贫血基因疗法Zynteglo，喜获欧盟有条件的上市许可

2019-10-27

xinxin088 (审核中...)

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#上市许可#

药品上市许可持有人制度拟延长试点期限

2019-07-12

xinxin088 (审核中...)

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#上市许可#

Waylivra在欧洲授予有条件的上市许可，治疗家族性家族性高乳糜微粒血症

2019-07-24

xinxin088 (审核中...)

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#上市许可#

国家药监局：新药上市许可行政审批时限压缩1/3

2019-09-17

xinxin088 (审核中...)

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#上市许可#

药监局发布药品上市许可持有人不良反应监测年度报告撰写规范

2019-07-06

xinxin088 (审核中...)

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#上市许可#

《关于发布上市许可持有人直接报告药品不良反应常见问答文件的通知》（2018年第66号）

2019-07-17

hb2008ye (审核中...)

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#上市许可#

国家药监局：药品上市许可持有人应健全药品不良反应监测体系

2019-08-01

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