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On May 24, the State Food and Drug Administration issued an announcement stating that, according to the results of the adverse drug reaction assessment, in order to further ensure the safety of public medication, the State Drug Administration decided to impose restrictions on Changyanning preparations, Yinzhihuang oral preparations and ginkgolide injectio.
The relevant matters are hereby announced as follows:
The relevant matters are hereby announced as follows:The marketing authorization holders of the above-mentioned drugs should submit a supplementary application for the revision of the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration" and the requirements for the revision of the instructions (see attachment), and report to the provincial drug administration before August 19, 202 Management recor.
If the revised content involves the drug label, it shall be revised together; the instructions and other contents of the label shall be consistent with the original approved conte.
The drug marketing authorization holder shall conduct in-depth research on the occurrence mechanism of newly added adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety issues, and guide doctors, pharmacists and patients to use drugs rational.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug insert sheets, and should conduct adequate benefit/risk analysis according to the newly revised insert sheets when choosing medicati.
Patients should read the instructions carefully before taking medication, and those who use prescription drugs should strictly follow the doctor's instructio.
The provincial drug regulatory authorities shall promptly urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in the revision of the corresponding instructions and the replacement of labels and instructions as required, and strictly investigate and punish violations of laws and regulations in accordance with the l.
