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According to the results of the drug adverse reaction assessment, in order to further ensure the safety of public drug use, the State Drug Administration decided to make a unified revision of the warning words, "adverse reactions" and "precautions" of the quick-acting heart-saving pill instructions.
The relevant matters will now be announced as follows: First, the market license holder of this product shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, in accordance with the revised requirements of the corresponding instructions (see annex), report to the provincial drug regulatory department for the record by April 13, 2021.
the contents of the drug shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval contents.
the original drug instructions for medicines produced on the date of filing.
drug market license holder shall replace the factory-issued drug instructions and labels within 9 months of filing.
. Drug market license holders shall conduct in-depth research on the mechanism for the occurrence of new adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety issues, and guide physicians and patients to use drugs rationally.
, clinicians should carefully read the revision of this product description, in the choice of medication, should be in accordance with the new revision of the manual to carry out adequate benefit/ risk analysis.
, patients should carefully read the drug instructions before taking the drug, the use of prescription drugs, should strictly follow the doctor's instructions for medication.
. The provincial drug supervision and administration department shall urge the holders of the drug listing licenses of the products in the administrative area to do a good job in revising the corresponding instructions and changing the labels and instructions as required, and severely investigate and punish violations of laws and regulations in accordance with the law.
this announcement.
: Quick-acting heart-saving pill instructions revised requirements of the State Drug Administration January 14, 2021
