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In accordance with the revised requirements, quick-acting heart-saving pill instructions should include the prohibition of pregnant women, "adverse reactions" should increase nausea, vomiting, dry mouth, headache, dizziness, rash, itching, redness, fatigue, allergies and allergic reactions, "taboo" should be added "pregnant women disabled" and "allergic to this product and the ingredients contained in the disablement", "precautions" should increase the use of allergic physique.
Quick-acting heart-saving pills for Tianjin Zhongxin Pharmaceutical Group Co., Ltd., the sixth Chinese medicine factory's exclusive varieties, is commonly used heart disease first aid drugs, viable gas live blood, pain relief, increase coronary blood flow, relieve angina, used for hysteresis-type coronary heart disease and angina.
public information shows that the product was modified in August 2016 in the contents of the manual without warning, "adverse reactions" and "taboo" items are "not clear", "precautions" include pregnant women disabled, allergy history of people with caution.
according to the announcement of the State Drug Administration, the license holder of the product shall, in accordance with the relevant provisions and in accordance with the revised requirements of the corresponding instructions, report the instructions to the provincial drug regulatory department for the record by April 13, 2021.
of the amendment relates to the drug label, it shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval content.
the original drug instructions for medicines produced on the date of filing.
Drug market license holders shall replace the factory-issued drug instructions and labels within 9 months after filing, conduct in-depth research on the mechanism for the occurrence of new adverse reactions, take effective measures, do a good job in publicity and training on drug use and safety issues, and guide physicians and patients to use drugs rationally.
