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On January 17, the State Food and Drug Administration issued an announcement stating that, in order to further ensure the safety of public medication, based on the results of the adverse drug reaction assessment, it was decided that the drug preparations (including Arbidol Hydrochloride Tablets, Arbidol Hydrochloride Dispersible Tablets) should be restricted.
, Arbidol Hydrochloride Granules, Arbidol Hydrochloride Capsules) have been revised uniformly
.
1.
The marketing authorization holders of the above-mentioned drugs should report to the State Drug Administration before April 12, 2022 in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration", and in accordance with the requirements for the revision of the instructions for arbidol preparations (see attachment).
The review center or the provincial drug regulatory authority for record
.
If the revised content involves the drug label, it shall be revised together; the instructions and other contents of the label shall be consistent with the original approved content
.
Drugs produced from the date of filing shall not continue to use the original drug inserts
.
The holder of the drug marketing authorization shall replace the package insert and label of the manufactured drug within 9 months after filing
.
2.
The drug marketing authorization holder shall conduct in-depth research on the mechanism of newly added adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety-related issues, and guide physicians and pharmacists to rationally use drugs
.
3.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug inserts, and conduct adequate risk/benefit analysis according to the newly revised inserts when choosing medication
.
4.
Patients should read the instructions carefully before taking the medicine, and the prescribed drugs should strictly follow the doctor's advice
.
5.
Provincial drug regulatory authorities shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing the labels and instructions as required, and strictly investigate and punish violations of laws and regulations in accordance with the law
.
Attachment: Amendment requirements for the instructions for arbidol preparations 1.
The item [adverse reactions] should include but not be limited to the following: The following adverse reactions were reported in post-marketing surveillance (incidence unknown): Gastrointestinal system: diarrhea, abdominal Discomfort, bloating, nausea, vomiting, loss of oral sensation
.
Hepatobiliary system: abnormal liver function, jaundice, elevated blood bilirubin, elevated liver enzymes
.
Skin and subcutaneous tissue: rash, itching
.
Nervous system and psychiatric reactions: dizziness, decreased appetite
.
Metabolic and nutritional disorders: elevated blood uric acid, dyslipidemia
.
Systemic damage: fatigue, pain
.
Cardiovascular System: Bradycardia
.
Immune system: allergic reaction
.
Other: myalgia, abnormal serum creatinine, low white blood cell count
.
2.
[Precautions] should include but not be limited to the following: Pregnant and lactating women, patients with severe renal insufficiency, and patients with sinus node disease or insufficiency should use with caution
.
3.
The item [Medication for Pregnant and Lactating Women] is revised to the following: There is no sufficient evidence on the efficacy and safety of this product for pregnant and lactating women, and it should be used with caution in pregnant and lactating women
.
(Note: If other contents of the manual are inconsistent with the above revision requirements, they should be revised together
.
)
, Arbidol Hydrochloride Granules, Arbidol Hydrochloride Capsules) have been revised uniformly
.
1.
The marketing authorization holders of the above-mentioned drugs should report to the State Drug Administration before April 12, 2022 in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration", and in accordance with the requirements for the revision of the instructions for arbidol preparations (see attachment).
The review center or the provincial drug regulatory authority for record
.
If the revised content involves the drug label, it shall be revised together; the instructions and other contents of the label shall be consistent with the original approved content
.
Drugs produced from the date of filing shall not continue to use the original drug inserts
.
The holder of the drug marketing authorization shall replace the package insert and label of the manufactured drug within 9 months after filing
.
2.
The drug marketing authorization holder shall conduct in-depth research on the mechanism of newly added adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety-related issues, and guide physicians and pharmacists to rationally use drugs
.
3.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug inserts, and conduct adequate risk/benefit analysis according to the newly revised inserts when choosing medication
.
4.
Patients should read the instructions carefully before taking the medicine, and the prescribed drugs should strictly follow the doctor's advice
.
5.
Provincial drug regulatory authorities shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing the labels and instructions as required, and strictly investigate and punish violations of laws and regulations in accordance with the law
.
Attachment: Amendment requirements for the instructions for arbidol preparations 1.
The item [adverse reactions] should include but not be limited to the following: The following adverse reactions were reported in post-marketing surveillance (incidence unknown): Gastrointestinal system: diarrhea, abdominal Discomfort, bloating, nausea, vomiting, loss of oral sensation
.
Hepatobiliary system: abnormal liver function, jaundice, elevated blood bilirubin, elevated liver enzymes
.
Skin and subcutaneous tissue: rash, itching
.
Nervous system and psychiatric reactions: dizziness, decreased appetite
.
Metabolic and nutritional disorders: elevated blood uric acid, dyslipidemia
.
Systemic damage: fatigue, pain
.
Cardiovascular System: Bradycardia
.
Immune system: allergic reaction
.
Other: myalgia, abnormal serum creatinine, low white blood cell count
.
2.
[Precautions] should include but not be limited to the following: Pregnant and lactating women, patients with severe renal insufficiency, and patients with sinus node disease or insufficiency should use with caution
.
3.
The item [Medication for Pregnant and Lactating Women] is revised to the following: There is no sufficient evidence on the efficacy and safety of this product for pregnant and lactating women, and it should be used with caution in pregnant and lactating women
.
(Note: If other contents of the manual are inconsistent with the above revision requirements, they should be revised together
.
)