备案号 | Y国备2024000646 |
---|---|
药品通用名称 | 盐酸帕罗西汀 |
英文名称/拉丁名称 | Paroxetine Hydrochloride |
药品批准文号/注册证书/原料药登记号 | 暂无权限 |
生产企业 | 暂无权限 |
生产企业(英文) | Apitoria Pharma Private Limited |
生产企业地址 | Unit I, Sy. Nos. 379, 385, 386, 388 to 396, Borpatla Village, Hathnoora Mandal, Sanga Reddy District, Telangana, India, Pin code 502296 |
上市许可持有人 | Apitoria Pharma Private Limited |
上市许可持有人(英文) | Apitoria Pharma Private Limited |
上市许可持有人地址 | Unit I, Sy. Nos. 379, 385, 386, 388 to 396, Borpatla Village, Hathnoora Mandal, Sanga Reddy District, Telangana, India, Pin code 502296 |
境外生产药品注册代理机构 | 安若维他药业泰州有限公司 |
境外生产药品注册代理机构地址 | 泰州市医药高新区祥泰路196号 |
备案内容 | 暂无权限 |
备案机关 | 国家药品监督管理局药品审评中心 |
备案日期 | 2024-04-02 |
备注 | 经审查,此次备案涉及原料药登记人实际变更,请登记人按照补充申请进行申报。 |
Apitoria Pharma Private Limited生产的盐酸帕罗西汀(批号:Y20200001156);
已于2024-04-02进行备案
盐酸帕罗西汀
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