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NMPA Announcement on the Revision of the Package Insert of the Oxiracetam Preparations

CCFDIE| Updated: 2021-06-24

In accordance with the results of adverse drug reaction evaluation, to further protect drug safety for the people, the NMPA decided to modify the items of [Adverse reactions], [Contraindications] and [Precautions] in the package inserts of oxiracetam preparations. On June 22, relevant issues are hereby announced as follows:

I. The marketing authorization holder of the product shall, in accordance with the Provisions for Drug Registration and the revision requirements for the package insert of oxiracetam preparations, file a report as such before September 21, 2021 to provincial drug regulatory authority.

Where the contents of revision involve the drug label, the label shall be revised along with all the others; the other contents of the label and insert sheets shall be consistent with those originally approved. For the drugs produced from the date of filing, the original package insert shall not be used any more. All the package inserts and labels of ex-factory drugs shall be changed within 9 months after the said revision had been filed by the marketing authorization holder of drug.

II. The marketing authorization holder of drug shall conduct in-depth research on the occurrence mechanism of new adverse reactions, take effective measures to publicize the training on drug use and safety issues, to guide the physician, pharmacist and patient to use the medicine rationally.

III. The clinicians and pharmacists shall carefully read the revised contents of the package inserts for oxiracetam preparations. Drug options should be based on comprehensive benefit/risk analysis as per the new revisions.

IV. The patients should carefully read the package inserts before medication, and strictly comply with the medication orders for prescription drugs.

V. Provincial drug regulatory authorities shall urge the drug marketing authorization holders of the product within their respective jurisdiction to revise the package inserts and replacement of the labels and package inserts as required and impose severe punishment in accordance with the law for violations of laws and regulations.