Yuheng pharmaceutical, a new Chinese medicine, Ginkgolide B and ginkgolide B injection received supplementary information notice
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Last Update: 2015-01-07
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Source: Internet
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Author: User
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Yuheng pharmaceutical announced on the evening of January 6 that the company had received the notice of supplementary information (ysbz [2015] No 0011, ysbz [2015] No 0012) issued by the drug review center of the State Food and drug administration It is announced that the review center has carried out technical review on the first class new Chinese medicine Ginkgolide B and ginkgolide B injection (acceptance No cxzs1100053 and cxzs1100054) declared by the company, and the company is required to supplement relevant information to the review center before May 19, 2015 The company said that it would provide relevant information to the review center in accordance with the requirements of the notice of supplementary information, but there is some uncertainty about the success of the application for approval of new drugs Announcement of Harbin Yuheng Pharmaceutical Co., Ltd on receiving the supplementary information notice of Ginkgolide B and ginkgolide B injection the company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without any false record, misleading statement or major omission On January 5, 2015, Harbin Yuheng Pharmaceutical Co., Ltd (hereinafter referred to as "the company") received the supplementary information notice (ysbz [2015] No 0011, ysbz [2015] No 0012) issued by the drug evaluation center of the State Food and Drug Administration (hereinafter referred to as "the Evaluation Center") The Evaluation Center conducted technical evaluation on the new drug Ginkgolide B and ginkgolide B injection (acceptance No.: cxzs1100053 and cxzs1100054) declared by the company, and required the company to supplement relevant information to the evaluation center before May 19, 2015 The company will provide relevant information to the review center in accordance with the requirements of the notice of supplementary information There is a certain uncertainty in the success of the approval of new drugs Please make careful decisions and pay attention to the investment risks It is hereby announced Board of directors of Harbin Yuheng Pharmaceutical Co., Ltd January 7, 2015
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