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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, according to the results of the adverse drug reaction assessment, it was decided that the arbidol preparations (including arbidol hydrochloride tablets, and arbidol hydrochloride dispersible tablets) should be restricted.
1.
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
2.
3.
4.
5.
Attachment: Requirements for Amendment of Instructions for Arbidol Preparations
Attachment: Requirements for Amendment of Instructions for Arbidol Preparations1.
The following adverse reactions (incidence unknown) were reported with this product during post-marketing surveillance:
Gastrointestinal system: diarrhea, abdominal discomfort, bloating, nausea, vomiting, hypoesthesia in the mouth
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.
[Notes] shall 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 [Medications for Pregnant and Lactating Women] is revised to the following:
There is no sufficient evidence for the efficacy and safety of this product in 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
.
)
