The State Drug Administration approves the application for registration of the import of the Ikuju single anti-injection fluid
-
Last Update: 2020-06-11
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
-in-the-
hemoglobineuria (PNH) is an acquired hematopoietic stem cell clone disease of endogenous tonic inhibitors on the surface of blood cells;PNH and aHUS are among the rare diseases in the world, and the eku-jumono-resistant injection controls both diseases by suppressing the rehydration pathway of the immune responsetoday, the NationalDrug(the Supervisory Authority announced that it recently approved the import registration application for Eculizumab Injection) for the treatment of adult and child haemophilic hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)on the Ikuju mono-injectionIkuju mono-injection by the Swiss AlexionCompany(research and development, by Hangzhou TigerPharmaceutical(Technology Co., Ltd.
agent(declaration of import registration)theof theproduct (which is a clinically urgently needed variety), the Fda-based Drug Review Centre of the National Drug Administration has included it in the priority review process for review At the same time, the organization of expert consultation (will discuss whether to exempt the registration of clinical experts assessed that the product has been approved for listing abroad, clinical efficacy is clear, risk control, agreed to exempt the product registered clinical trial (and considering that increasing child indications will bring greater benefits to the child population than risk, recommended to approve At the same time, however, applicants are required to supplement the effectiveness and safety information of the product after its launch, continue clinical trials as planned, and dynamically revise the risk management plan the State Drug Administration has expedited the completion of the technical review of this product in accordance with the priority review procedure and will conditionally approve the registration of the import of this product on 4 September 2018
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.