Just passed the registration of science and technology innovation board, and modified the instruction manual of micro core biological core products

On July 17, the CSRC agreed to register the initial public offering of shares on the technology innovation board of Shenzhen micro core Biotechnology Co., Ltd On July 18, the State Food and Drug Administration issued the notice on Revising the instructions of xidaban tablets (No 59, 2019), which decided to revise the instructions of xidaban tablets [adverse reactions] and [precautions], etc In order to further ensure the safety of drug use by the public, the State Drug Administration decided to revise the instructions [adverse reactions] and [precautions] of xidaban tablets The relevant matters are hereby announced as follows: 1 The manufacturer of xidaban tablets shall, in accordance with the measures for the administration of drug registration and other relevant provisions, put forward the supplementary application for the revision of the instructions of xidaban tablets (see the annex), and report to the provincial drug regulatory authority for the record before September 16, 2019 If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents Replace all drug instructions and labels that have been delivered within 6 months after the supplementary application is filed The manufacturers of xidaban tablets shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do well in the publicity and training of the use and safety issues, and immediately notify the drug dealers and users of the changes in the content related to drug safety in an appropriate way to guide doctors and pharmacists in the rational use of drugs 2、 Clinicians and pharmacists should carefully read the revised instructions of xidaban tablets, and make full benefit / risk analysis according to the newly revised instructions when choosing drugs 3、 Patients should strictly follow the doctor's instructions and read the instructions carefully before using the medicine It is hereby announced Appendix: the revised specification of xidaban tablets requires the State Food and drug administration to revise the specification of xidaban tablets on July 16, 2019 The following content is added to the [adverse reactions] [adverse reactions] item: the adverse event report of heart failure and interstitial pneumonia is detected after the market, the incidence is unknown, and the correlation cannot be excluded 2、 The following content is added under "special precautions" in [precautions] and [precautions]: adverse event reports of heart failure and interstitial pneumonia are detected after listing, the incidence is unknown, and the correlation cannot be excluded (Note: if other contents of the manual are inconsistent with the above revision requirements, they shall be revised together.)