Announcement of the State Food and Drug Administration on Revising the Instructions for Ginkgo Damo Injection (No. 71 of 2021)

In order to further protect the safety of public medication, the National Medical Products Administration has decided to revise the instructions for Ginkgo Damo injection
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The relevant matters are hereby announced as follows: 1.
The marketing authorization holder of this product should submit a supplementary application for the revision of the insert in accordance with the requirements for the revision of the insert sheet of Ginkgo Damo injection in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations.
Before August 19, 2021, report to the Drug Evaluation Center of the National Medical Products Administration or the provincial drug regulatory authority for record
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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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Drugs produced on the date of filing shall not continue to use the original drug instructions
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The holder of the drug marketing authorization shall replace all the drug insert sheets and labels that have been shipped out of the factory within 9 months after filing
.
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 the use and safety issues, and immediately notify the drug business and use of changes in the content of drug safety.
The unit, instructs physicians and pharmacists to use drugs rationally
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3.
Clinicians and pharmacists should carefully read the revised contents of the Ginkgo Damo injection instructions, and when choosing medications, they should conduct a sufficient benefit/risk analysis based on the newly revised instructions
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4.
The patient should read the instructions carefully before taking the medicine, and 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
.
Hereby announce
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Attachment: Requirements for the revision of the leaflet of Ginkgo Damo injection.
National Medical Products Administration May 19, 2021.
National Medical Products Administration Announcement No.
71 in 2021.
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