The State Drug Administration's announcement on revising the instructions of the amino sugar centered preparation preparation

The State Drug Administration's announcement on revising the instructions of the amino sugar centered preparation preparation

(2022 No. 49)

According to the results of adverse drug reactions, in order to further ensure the safety of public medication, the State Drug Administration decided to make ammonia sugar centered agents (including amino sugar -cenonine tablets, amino sipyl -soluble casinges, amino sugar cream slowly release Capsules) The content of the manual is uniformly revised. The relevant matters are announced as follows:

I. The listing permits of the above drugs shall, in accordance with the relevant provisions of the "Administrative Measures for the Registration of Drugs", in accordance with relevant regulations, in accordance with the requirements of the instructions (see attachments) of the amino sugar preparation instructions (see attachments), report to the National Drug Administration of Drugs before September 21, 2022 A review center or provincial drug supervision and management department.

If the revised content involves drug labels, it should be revised together; the instructions and other contents of the label should be consistent with the original approval content. Drugs produced from the date of filing shall not continue to use the original drug instructions. The holder of the drug listing permit shall be replaced by the drug manual and label of the factory within 9 months after the filing.

2. The holder of the drug listing permit shall conduct in -depth research on the mechanism of new adverse reactions, take effective measures to do a good job of publicity and training of drug use and safety issues, and guide physicians and pharmacists to use medicine reasonably.

3. Clinicians and pharmacists should carefully read the amendments to the above -mentioned drug manuals. When choosing a medication, they should conduct full benefit/risk analysis based on the new revision instructions.

Fourth, patients should read the drug instructions carefully before taking the medicine. If the prescription medicine is used, the medicine should be strictly obeyed.

V. Provincial pharmaceutical supervision and management department shall urge the drug listing license holders of the above drugs in the administrative area to make the corresponding instructions and labels and instruction replacement in accordance with the requirements, and severely investigate and punish illegal and illegal acts in accordance with the law.

Special announcement.

Attachment: Revision Revision Revision Revisive Revision

State Drug Administration

June 22, 2022

appendix

Attachment: Revision Revision Revision Revisive Revision

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