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药品名称
注册分类
申请类型
承办日期
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办理状态
状态日期
新报审评通道
审评结论
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拉米夫定多替拉韦片
化药
进口再注册
2025-07-11
ViiV Healthcare BV;GlaxoSmithKline LLC；Glaxo Wellcome S.A.;GlaxoSmithKline (China) Investment Company Limited;
盐酸非索非那定片
化药5.1
进口再注册
2025-07-11
OPELLA HEALTHCARE FRANCE SAS;SANOFI WINTHROP INDUSTRIE;Opella Healthcare (Shanghai) Co Ltd.;
盐酸非索非那定片
化药5.1
进口再注册
2025-07-11
OPELLA HEALTHCARE FRANCE SAS;SANOFI WINTHROP INDUSTRIE;Opella Healthcare (Shanghai) Co Ltd.;
瑞派替尼片
化药5.1
进口再注册
2025-07-11
Deciphera Pharmaceuticals，LLC;Lonza Bend Inc.;Zai Lab (Shanghai) CO., Ltd.;
羧基麦芽糖铁注射液
化药5.2
进口
2025-07-11
M/s MSN LABORATORIES PRIVATE LIMITED;M/s MSN LABORATORIES PRIVATE LIMITED;Shenzhen Foncoo Pharmaceutical Co. , Ltd.;
羧基麦芽糖铁注射液
化药5.2
进口
2025-07-11
M/s MSN LABORATORIES PRIVATE LIMITED;M/s MSN LABORATORIES PRIVATE LIMITED;Shenzhen Foncoo Pharmaceutical Co. , Ltd.;
卡替拉韦注射液
化药5.1
补充申请
2025-07-11
ViiV Healthcare BV;Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations);
卡替拉韦钠片
化药5.1
补充申请
2025-07-11
ViiV Healthcare BV;Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations);
Depemokimab注射液
治疗用生物制品1
补充申请
2025-07-11
GlaxoSmithKline (Ireland) Limited;Glaxo Operations UK Ltd. Trading as Glaxo Wellcome Operations;
补充申请