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According to the evaluation results of adverse drug reactions, in order to further protect the safety of public medication, the National Medical Products Administration has decided to treat oxaliplatin preparations (including oxaliplatin for injection, oxaliplatin injection, oxaliplatin mannitol injection) ) The contents of the manual are revised uniformly
.
The relevant matters are hereby announced as follows: 1.
The marketing authorization holders of the above-mentioned drugs shall be in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, in accordance with the requirements for the revision of the oxaliplatin preparation instructions (see attachment), before November 22, 2021 Report to the provincial drug supervision and administration department for the record
.
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 on 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 and pharmacists to use drugs rationally
.
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 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 strictly investigate and deal with violations of laws and regulations in accordance with the law
.
Hereby announce
.
Attachment: Requirement for the revision of the oxaliplatin preparation instructions.
National Medical Products Administration August 23, 2021 National Medical Products Administration Announcement No.
102 of 2021 Annex.
docx
.
The relevant matters are hereby announced as follows: 1.
The marketing authorization holders of the above-mentioned drugs shall be in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, in accordance with the requirements for the revision of the oxaliplatin preparation instructions (see attachment), before November 22, 2021 Report to the provincial drug supervision and administration department for the record
.
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 on 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 and pharmacists to use drugs rationally
.
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 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 strictly investigate and deal with violations of laws and regulations in accordance with the law
.
Hereby announce
.
Attachment: Requirement for the revision of the oxaliplatin preparation instructions.
National Medical Products Administration August 23, 2021 National Medical Products Administration Announcement No.
102 of 2021 Annex.
docx
