The State Drug Administration has recently approved the application for registration of the import of the Emmys- and TheU-Z.
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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according to the official website of the State Drug Administration, the StateDrug(http://Supervision Authority has recently approved the import registration application for Themesa-Zunad-mono-injection (Emicizumab Injection) for the treatment of patients with type A haemophiliacs with the presence of coagulation factor VIIIinhibitorson theEmmys single anti-injectionEmmys adronization by Rochecompany(http://, is a recombinant humanized, dual-specific monoclonal antibody, can replace the cofactor activity of activated coagulation factor VIII, promote THE activation of FIX.a to FX, and thus lead to a significant increase in the production of coagulation enzyme, so that FEmmy-bead monoantigen, as a clinically urgently needed variety, was included in the priority review process to expedite the review and approvalIn view of the clear clinical efficacy of this product, the risk can be controlled, good tolerance, good drug-giving facilitation compliance, there is no clear efficacy and safety differences between patients of different racesNovember 30, the State Drug Administration approved the import registration of the Emmys single anti-injection fluid for routine preventive treatment for patients with type A haemophiliacs (congenital coagulation factor VIIIdeficiency) who are present with coagulation factor VIII to prevent bleeding or reduce the frequency of bleedingin accordance with the relevant spirit of the CPC Central Committee and the State Council in deepening the reform of the drug review and approval system, the State Drug Administration continues to speed up the import registration of new drug(http://oflisted overseas, optimize the review process for drugs for the treatment of rare diseases and some drugs for the prevention and treatment of serious life-threatening diseases, simplify the listing requirements, and ensure the early use of new drugs listed abroad by chinese patients
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