I. Main Content of the Drug Supplemental Application Approval Notice
Recently, Shandong Linuo Pharmaceutical Co., Ltd. (hereinafter "Linuo Pharmaceutical"), a wholly-owned subsidiary of Shandong Keyuan Pharmaceutical Co., Ltd. (hereinafter the "Company"), received the Drug Supplemental Application Approval Notice issued by the National Medical Products Administration. The main content is as follows:
| Drug Name | Registration Category | Specification | Marketing Authorization Holder | Approval Number | Approval Conclusion |
|---|---|---|---|---|---|
| Betahistine Hydrochloride Tablets | Chemical Drug | 4mg | Linuo Pharmaceutical | National Medicine Approval H20269094 | Upon review, this application meets the relevant requirements for drug registration. It is agreed, in accordance with the relevant provisions of the "Administrative Measures for Post-Marketing Changes of Drugs (Trial)", to approve the change of the marketing authorization holder of this product from "Senmiao (Shandong) Pharmaceutical Co., Ltd." to "Shandong Linuo Pharmaceutical Co., Ltd.", with the drug approval number remaining unchanged. |
| Betahistine Hydrochloride Tablets | Chemical Drug | 8mg | Linuo Pharmaceutical | National Medicine Approval H20243912 | Same as above |