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    Home > Medical News > Latest Medical News > The State Food and Drug Administration revised the instructions for 10 dosage forms including antiviral syrup and capsules

    The State Food and Drug Administration revised the instructions for 10 dosage forms including antiviral syrup and capsules

    • Last Update: 2021-10-20
    • Source: Internet
    • Author: User
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    On October 12, according to the results of the adverse drug reaction assessment, in order to further protect the safety of public medication, the National Medical Products Administration decided to fight virus syrup, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewing The instructions for tablets, oral liquids, and granules will be revised in a unified way
    .

    details as follows:

    details as follows:

    1.
    The marketing authorization holders of the above-mentioned drugs shall be in accordance with the "Drug Registration Management Measures" and other relevant regulations, in accordance with antiviral syrups, capsules, soft capsules, pills (concentrated pills), drop pills, tablets, effervescent tablets, chewable tablets, Revision requirements for the leaflets of prescription drugs and over-the-counter drugs for oral liquids and granules (see Annex 1 and 2) shall be reported to the provincial drug supervision and administration department for record before December 27, 2021
    .

    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
    .
    Drugs produced since the date of filing shall not continue to use the original drug instructions
    .
    The holder of the drug marketing authorization shall replace the instructions and labels of the drugs 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 drug use and safety issues, and guide physicians, pharmacists and patients in the rational use of drugs
    .

    3.
    Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug inserts, and when choosing medications, they should conduct a sufficient benefit/risk analysis based on the newly revised inserts
    .

    4.
    The patient should read the drug insert carefully before taking the medicine.
    If using prescription drugs, they should strictly follow the doctor's advice
    .

    5.
    The provincial drug supervision and administration department shall promptly supervise and urge the drug marketing license holders of the above-mentioned drugs 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
    .

    attachment1

    attachment1

    Revision requirements for prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    Revision requirements for prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    1.
    [Adverse reactions] items should include:

    Monitoring data show that the product can see the following adverse reactions: nausea, vomiting, diarrhea, abdominal pain, bloating, abdominal discomfort, rash, itching, and allergic reactions
    .

    2.
    [Taboo] item should be added:

    People who are allergic to this product and its ingredients are prohibited
    .

    3.
    [Precautions] item should be added:

    1.
    Use it with caution if you have diarrhea if you are chronically ill and physically weak
    .

    2.
    Use with caution for people with allergies
    .

    3.
    This product contains turmeric, it is not suitable to be used together with cloves and mother cloves
    .

    Annex 2

    Annex 2

    Revision requirements for non-prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    Revision requirements for non-prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    1.
    [Adverse reactions] items should include:

    Monitoring data show that the product can see the following adverse reactions: nausea, vomiting, diarrhea, abdominal pain, bloating, abdominal discomfort, rash, itching, and allergic reactions
    .

    2.
    [Taboo] item should be added:

    People who are allergic to this product and its ingredients are prohibited
    .

    3.
    [Precautions] item should be added:

    1.
    Use it with caution if you have diarrhea if you are chronically ill and physically weak
    .

    2.
    This product contains turmeric, it is not suitable to be used together with cloves and mother cloves
    .

    4.
    [Precautions] item should be changed:

    "Patients with severe chronic diseases such as hypertension, heart disease, liver disease, diabetes, kidney disease should be taken under the guidance of a physician
    .
    " Should be revised to: "Patients with hypertension, heart disease, liver disease, diabetes, kidney disease, etc.
    should be taken under the guidance of a physician
    .
    "

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