Shandong Xinhua Pharmaceutical Company Limited received the Notification of Approval of Supplementary Drug Application issued by the National Medical Products Administration in connection with the approval of marketing authorisation holder (MAH) transfer application in relation to the Peramivir Injection (15ml: 0.15g). Drug name: Peramivir Injection. Dosage form: Injection.

Specifications: 15ml:0.15g (according to C15H28N4O4). Drug category: Prescription drugs. Registered classification: Chemicals.

Applicant: Shandong Xinhua Pharmaceutical Company Limited. Application matter: Supplementary Application (Change of Marketing Authorisation Holder). Case number: CYHB2400368.

Original drug approval number: Guoyao Zhunzi H20243128. Notification number: 2024B01462. Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and relevant regulation, after examination, the application for the Product meets the relevant requirements for drug registration and the change of the marketing permit holder of this product from "Suzhou Amerigen Pharmaceutical Co.

Ltd." to "Shandong Xinhua Pharmaceutical Co. Ltd." in accordance with the relevant provisions of the Measures for the Administration of Changes after Drug Listing (Trial) has been approved, with the drug approval number unchanged.