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CFDA request to amend the instructions involved motherwort particles had hundreds of pharmaceutical companies
 
Author:中國銘鉉 企劃部  Release Time:2017-3-1 15:50:20  Number Browse:802
 
Medical news network February 28th February 27th, the State Food and Drug Administration issued a notice to modify the specification of motherwort granules.
Announcement shows that, motherwort particles modify as follows:
The revised specification non prescription drug Yimu granules
First, [indications] item is changed to:
Huoxue Tiaojing, xingqizhitong. For qi stagnation blood stasis due to irregular menstruation, dysmenorrhea.
Two, [taboo] item is changed to:
Pregnant women and menorrhagia contraindication.
The agency said: all non prescription drug Yimu granules production enterprises shall be based on the relevant provisions of "drug registration management measures", in accordance with the revised specifications prescription Yimu granules, supplement the proposed amendments to the specification of the application, in March 30, 2017 before the provincial food and drug regulatory department.
Amendments to the contents of the drug labels shall be amended in accordance with the provisions of the prospectus and other content should be consistent with the original approval. In addition to the date of filing the application for the production of drugs, shall not continue to use the original drug instructions.
At the same time, the Administration reiterated: Yimu granules of non prescription drugs, should read the instructions carefully before treatment in patients with Yimu granules.
According to the administration's official website to verify, a total of 190 approval numbers of motherwort granules.
 
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