According to the website of the National Medical Products Administration, based on the results of adverse drug reaction assessment, in order to further ensure the safety of public medication, the National Medical Products Administration has decided to uniformly revise the instructions of oral calcium dobesylate preparations (including calcium dobesylate capsules, calcium dobesylate tablets, calcium dobesylate dispersible tablets, and calcium dobesylate granules). According to the announcement, the holder of the marketing license for the above-mentioned drugs shall revise the instructions in accordance with relevant regulations such as the Drug Registration Management Measures, and submit them to the Drug Evaluation Center of the National Medical Products Administration or the provincial drug regulatory department for filing before June 30, 2024. If the revised content involves drug labeling, it should be revised together; The instruction manual and other contents on the label should be consistent with the original approved content. Drugs produced from the date of filing shall not continue to use the original drug instructions. The holder of the drug marketing license shall replace the instructions and labels of the drugs that have already left the factory within 9 months after filing. The announcement clearly states that holders of drug marketing licenses should conduct in-depth research on the mechanisms of new adverse reactions, take effective measures to promote and train drug use and safety issues, and guide physicians and pharmacists in rational drug use. Clinicians and pharmacists should carefully read the revised content of the drug instructions mentioned above, and when choosing medication, they should conduct sufficient benefit/risk analysis based on the newly revised instructions. At the same time, the provincial drug supervision and administration department shall supervise the holders of marketing permits for the above-mentioned drugs in the administrative region to revise the corresponding instructions and replace the labels and instructions as required, and strictly investigate and punish illegal and irregular behaviors in accordance with the law. The National Medical Products Administration reminds patients to carefully read the drug instructions before taking medication. If using prescription drugs, they should strictly follow the doctor's instructions. (Outlook New Era Network)
Edit：GuoGuo Responsible editor：FangZhiYou
Source：people.cn
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