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Medical Network, July 27th.
Recently, the State Food and Drug Administration issued an announcement clarified that based on the results of the adverse drug reaction assessment, it has decided to make unified revisions to the instructions of propranolol tablets [Precautions] and other items
.
It is worth noting that there are differences in the opinions on the revision of the instructions for products that have passed the quality and efficacy consistency evaluation of generic drugs
.
Recently, the State Food and Drug Administration issued an announcement clarified that based on the results of the adverse drug reaction assessment, it has decided to make unified revisions to the instructions of propranolol tablets [Precautions] and other items
.
It is worth noting that there are differences in the opinions on the revision of the instructions for products that have passed the quality and efficacy consistency evaluation of generic drugs
.
For propranolol tablets that have passed the consistency evaluation, the instructions [Precautions] should be added under "Article 9 of this product with caution in the following situations: children (can cause severe hypoglycemia with cramps and lethargy)" "There are the following tips in the instructions of similar foreign drugs
.
" For propranolol tablets that have not passed the consistency evaluation, the following content should be added in the item of "Precautions": "Children should use this product with caution, and there are the following tips on children's medication in similar foreign drug inserts"
.
The contents mentioned are "Before starting propranolol treatment, it is necessary to screen for the risks related to the use of propranolol, analyze the medical history and carry out the corresponding clinical examination.
" "If there is a lower respiratory tract infection with breathing difficulties and wheezing, Then the drug should be temporarily stopped and seek medical attention in time” and other 5 items
.
.
" For propranolol tablets that have not passed the consistency evaluation, the following content should be added in the item of "Precautions": "Children should use this product with caution, and there are the following tips on children's medication in similar foreign drug inserts"
.
The contents mentioned are "Before starting propranolol treatment, it is necessary to screen for the risks related to the use of propranolol, analyze the medical history and carry out the corresponding clinical examination.
" "If there is a lower respiratory tract infection with breathing difficulties and wheezing, Then the drug should be temporarily stopped and seek medical attention in time” and other 5 items
.
The announcement requires that the holders of relevant drug marketing authorizations should revise the instructions in accordance with the corresponding requirements in accordance with the " Drug Registration Management Measures" and other relevant regulations, and report to the provincial drug regulatory authority for record before October 14, 2021
.
If the revised content involves the drug label, it should be revised together, and other contents of the insert sheet and label should be consistent with the original approved content
.
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
.
.
If the revised content involves the drug label, it should be revised together, and other contents of the insert sheet and label should be consistent with the original approved content
.
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
.
Medical Network, July 27th.
Recently, the State Food and Drug Administration issued an announcement clarified that based on the results of the adverse drug reaction assessment, it has decided to make unified revisions to the instructions of propranolol tablets [Precautions] and other items
.
It is worth noting that there are differences in the opinions on the revision of the instructions for products that have passed the quality and efficacy consistency evaluation of generic drugs
.
Recently, the State Food and Drug Administration issued an announcement clarified that based on the results of the adverse drug reaction assessment, it has decided to make unified revisions to the instructions of propranolol tablets [Precautions] and other items
.
It is worth noting that there are differences in the opinions on the revision of the instructions for products that have passed the quality and efficacy consistency evaluation of generic drugs
.
For propranolol tablets that have passed the consistency evaluation, the instructions [Precautions] should be added under "Article 9 of this product with caution in the following situations: children (can cause severe hypoglycemia with cramps and lethargy)" "There are the following tips in the instructions of similar foreign drugs
.
" For propranolol tablets that have not passed the consistency evaluation, the following content should be added in the item of "Precautions": "Children should use this product with caution, and there are the following tips on children's medication in similar foreign drug inserts"
.
The contents mentioned are "Before starting propranolol treatment, it is necessary to screen for the risks related to the use of propranolol, analyze the medical history and carry out the corresponding clinical examination.
" "If there is a lower respiratory tract infection with breathing difficulties and wheezing, Then the drug should be temporarily stopped and seek medical attention in time” and other 5 items
.
.
" For propranolol tablets that have not passed the consistency evaluation, the following content should be added in the item of "Precautions": "Children should use this product with caution, and there are the following tips on children's medication in similar foreign drug inserts"
.
The contents mentioned are "Before starting propranolol treatment, it is necessary to screen for the risks related to the use of propranolol, analyze the medical history and carry out the corresponding clinical examination.
" "If there is a lower respiratory tract infection with breathing difficulties and wheezing, Then the drug should be temporarily stopped and seek medical attention in time” and other 5 items
.
The announcement requires that the holders of relevant drug marketing authorizations should revise the instructions in accordance with the corresponding requirements in accordance with the " Drug Registration Management Measures" and other relevant regulations, and report to the provincial drug regulatory authority for record before October 14, 2021
.
If the revised content involves the drug label, it should be revised together, and other contents of the insert sheet and label should be consistent with the original approved content
.
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
.
.
If the revised content involves the drug label, it should be revised together, and other contents of the insert sheet and label should be consistent with the original approved content
.
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
.
Medical Network, July 27th.
Recently, the State Food and Drug Administration issued an announcement clarified that based on the results of the adverse drug reaction assessment, it has decided to make unified revisions to the instructions of propranolol tablets [Precautions] and other items
.
It is worth noting that there are differences in the opinions on the revision of the instructions for products that have passed the quality and efficacy consistency evaluation of generic drugs
.
Recently, the State Food and Drug Administration issued an announcement clarified that based on the results of the adverse drug reaction assessment, it has decided to make unified revisions to the instructions of propranolol tablets [Precautions] and other items
.
It is worth noting that there are differences in the opinions on the revision of the instructions for products that have passed the quality and efficacy consistency evaluation of generic drugs
.
For propranolol tablets that have passed the consistency evaluation, the instructions [Precautions] should be added under "Article 9 of this product with caution in the following situations: children (can cause severe hypoglycemia with cramps and lethargy)" "There are the following tips in the instructions of similar foreign drugs
.
" For propranolol tablets that have not passed the consistency evaluation, the following content should be added in the item of "Precautions": "Children should use this product with caution, and there are the following tips on children's medication in similar foreign drug inserts"
.
The contents mentioned are "Before starting propranolol treatment, it is necessary to screen for the risks related to the use of propranolol, analyze the medical history and carry out the corresponding clinical examination.
" "If there is a lower respiratory tract infection with breathing difficulties and wheezing, Then the drug should be temporarily stopped and seek medical attention in time” and other 5 items
.
Child, child, kid.
" For propranolol tablets that have not passed the consistency evaluation, the following content should be added in the item of "Precautions": "Children should use this product with caution, and there are the following tips on children's medication in similar foreign drug inserts"
.
The contents mentioned are "Before starting propranolol treatment, it is necessary to screen for the risks related to the use of propranolol, analyze the medical history and carry out the corresponding clinical examination.
" "If there is a lower respiratory tract infection with breathing difficulties and wheezing, Then the drug should be temporarily stopped and seek medical attention in time” and other 5 items
.
The announcement requires that the holders of relevant drug marketing authorizations should revise the instructions in accordance with the corresponding requirements in accordance with the " Drug Registration Management Measures" and other relevant regulations, and report to the provincial drug regulatory authority for record before October 14, 2021
.
If the revised content involves the drug label, it should be revised together, and other contents of the insert sheet and label should be consistent with the original approved content
.
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
.
Drugs Drugs Drugs Drug Registration Drug Registration Drug Registration .
If the revised content involves the drug label, it should be revised together, and other contents of the insert sheet and label should be consistent with the original approved content
.
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
.
