Announcement of the State Food and Drug Administration on Revising the Instructions for Suxiao Jiuxin Pills (No. 12 of 2021)

According to the evaluation results of adverse drug reactions, in order to further protect the safety of public use of drugs, the State Drug Administration has decided to uniformly revise the warnings, [adverse reactions], [taboos] and [precautions] items in the instructions of Suxiao Jiuxin Pills
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1.
The marketing authorization holder of this product shall revise the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration" and the corresponding instructions for revision requirements (see appendix), and report to the provincial drug regulatory authority for record before April 13, 2021
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If the revised content involves the label of a drug, it shall be revised together; the instructions and other content of the label shall be consistent with the original approved content
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2.
The drug marketing license holder shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to conduct publicity and training on drug use and safety issues, and guide physicians and patients in the rational use of drugs
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3.
Clinicians should carefully read the revised content of this product's instructions, and when choosing medications, they should conduct adequate benefit/risk analysis based on the newly revised instructions
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4.
The patient should read the drug insert carefully before taking the medicine.
If using prescription drugs, they should strictly follow the doctor's advice
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5.
The provincial drug supervision and administration department shall supervise and urge the drug marketing license holders of this product in the administrative area to do the corresponding manual revision and label and manual replacement work as required, and severely investigate and punish violations of laws and regulations in accordance with the law
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Hereby announce
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Attachment: Suxiao Jiuxin Pill instruction revision requirements

State Food and Drug Administration

January 14, 2021

Annex to Announcement No.