变更被对聚乙二醇4000来源(生产商）作出：在临床试验结束后以及准备申

变更被对聚乙二醇4000来源(生产商）作出：在临床试验结束后以及准备申报NDA过程中，2018年10月份决定将其来源由湖南尔康制药股份有限公司变更为南京威尔药业股份有限公司根据聚乙二醇4000登记情况及关联审评情况和风险评估，并相应的研究被开展了以支持该变更。

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结果 (英语) 1: [复制]

复制成功！

The change was made to the source of polyethylene glycol 4000 (manufacturer): After the clinical trial was completed and in the process of preparing for the NDA declaration, in October 2018 it was decided to change its source from Hunan Erkang Pharmaceutical Co., Ltd. to Nanjing Weill Pharmaceutical Based on the registration status of polyethylene glycol 4000, the related review and risk assessment, and corresponding research was carried out to support the change.

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结果 (英语) 2:[复制]

复制成功！

The change was made to the 4000 source (manufacturer) of polyglycol: after the completion of clinical trials and in the preparation of the declaration of NDA, it was decided in October 2018 to change its origin from Hunan Erkang Pharmaceutical Co., Ltd. to Nanjing Well Pharmaceutical Co., Ltd. based on polyglycol 4000 registration and associated review and risk assessment, and the corresponding research was carried out to support the change.

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结果 (英语) 3:[复制]

复制成功！

The change was made to the source (manufacturer) of polyethylene glycol 4000: after the completion of clinical trial and in the process of preparing to apply for NDA, in October 2018, it was decided to change its source from Hunan Erkang Pharmaceutical Co., Ltd. to Nanjing Weill Pharmaceutical Co., Ltd. according to the registration of polyethylene glycol 4000, the related review and risk assessment, and the corresponding research was carried out to support the change More.

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