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On November 20, the State Drug Administration issued the Notice of the State Drug Administration on the Revision of the Instructions for Mental health preparations (No. 127 of 2020).
, the revision is mainly an increase in adverse reactions, taboos and precautions to the instructions for mental health preparations.
Specifically include: First, the "adverse reactions" item should be increased: monitoring data show that the heart and brain health preparations have nausea, vomiting, dry mouth, abdominal pain, diarrhea, bloating, abdominal discomfort, rash, itching, dizziness, headache, chest tightness, palpitations, allergies or allergic reactions and other adverse reactions reported, liver function biochemic indicators abnormal case report.
, taboo items should be added: 1. People who are allergic to this product and the ingredients contained in it are prohibited.
2. Pregnant women are prohibited.
, "Precautions" items should be added: 1. This product contains the first Wu, to avoid the use of hepatotoxic drugs at the same time.
2. If abnormal liver biochemical indicators are found or the clinical manifestations of liver biochemical indicators are found to be abnormal or appear in the whole body, loss of appetite, anorexia, nausea, urine yellowing, yellowing, yellow skin, yellowing of skin, itching of the skin, etc. may be related to liver injury, or the original liver biochemical examination abnormalities, liver injury clinical symptoms aggravated, should immediately stop the drug and seek medical attention.
3. Allergic physiques are used with caution.
. Use with caution in lactating women.
Attached: The Announcement of the State Drug Administration on the Revision of the Instructions for Mental health preparations (No. 127 of 2020) In order to further safeguard the safety of public drug use, the State Drug Administration has decided to revise the instructions for mental health preparations (including tablets, capsules), "Adverse Reactions", "Taboos" and "Precautions" in accordance with the results of the evaluation of adverse drug reactions.
The relevant matters will now be announced as follows: First, all the above-mentioned drug market license holders shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, in accordance with the corresponding instructions for revision requirements (see annex) revision instructions, before February 9, 2021 to the provincial drug regulatory departments for the record.
the contents of the amendment relate to drug labels, they shall be revised together, and the instructions and other contents of the labels 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 shall carefully read the revision of the above-mentioned drug instructions and, when selecting the drug, conduct a full benefit/risk analysis in accordance with the newly revised instructions.
, 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 drug market license holders of the above-mentioned drugs in the administrative area to do a good job in revising the corresponding instructions and replacing the labels and instructions as required, and severely investigate and punish violations of laws and regulations in accordance with the law.
this announcement.
The State Drug Administration on November 10, 2020