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北大医药(000788.SZ)获批成为“磷酸奥司他韦干混悬剂”上市许可持有人

pku healthcare corp., (000788.SZ) has been approved as the holder of the marketing authorization for "oseltamivir phosphate granules for oral suspension"

Zhitong Finance ·  Nov 29 16:35

Pku healthcare corp. (000788.SZ) released an announcement stating that the company recently received the approved issuance from the National Medical Products Administration...

According to Zhitong Finance APP, pku healthcare corp. (000788.SZ) announced that the company recently received the "Notice of Approval for Supplementary Application of Pharmaceutical" issued by the National Medical Products Administration, concerning the product: "Oseltamivir phosphate dry suspension." Upon review, this application meets the relevant requirements for pharmaceutical registration and agrees to approve the holder of this product's marketing license to change from "Shandong Langnuo Pharmaceutical Co., Ltd." to "Pku Healthcare Corp.," with the pharmaceutical approval number remaining unchanged.

It is reported that oseltamivir phosphate works by targeting the neuraminidase of the influenza virus, inhibiting the release of mature influenza virus from host cells to suppress the transmission of the virus within the body, thus playing a role in the prevention and treatment of influenza. It is recommended in various domestic and international clinical guidelines for the prevention and treatment of type A and B influenza in adults and children. Oseltamivir phosphate dry suspension is included in the national medical insurance catalog for 2024 (Category B) and can be used for the treatment of type A and B influenza in adults and children over 2 weeks of age and for the prevention of influenza in children aged 1 year and older, demonstrating significant clinical efficacy and good safety in usage.

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