Revision of the over-the-counter drug Manual of Pudilan Xiaoyan tablet (capsule)

According to the results of monitoring and evaluation, in order to further protect the public drug safety, the State Drug Administration decided to revise the model manual of Pudilan Xiaoyan tablets (capsules) On November 6, the official website of the State Food and Drug Administration announced relevant matters as follows: 1 The manufacturer of Pudilan Xiaoyan tablets (capsules) over-the-counter drugs shall, in accordance with the measures for the administration of drug registration and other relevant regulations, comply with Pudilan Xiaoyan tablets (capsules) over-the-counter drugs The model specification (see Appendix 1 and 2) shall be submitted to the provincial drug regulatory authority for filing before December 31, 2018 If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents The drug produced from the date of filing of the supplementary application shall not continue to use the original drug description The over-the-counter drug manufacturers of Pudilan Xiaoyan tablets (capsules) shall take effective measures to do a good job of publicity and training on the use and safety of Pudilan Xiaoyan tablets (capsules) in a timely manner, and guide doctors, pharmacists and patients in the rational use of drugs 2、 Clinicians and pharmacists should carefully read the revised contents of the drug Manual of Pudilan Xiaoyan tablets (capsules), and make full benefit / risk analysis or guide drug use according to the newly revised manual when selecting or guiding drug use 3、 Patients should carefully read the over-the-counter drug instructions of Pudilan Xiaoyan tablets (capsules) before taking medicine 4、 Each provincial drug regulatory department shall urge the relevant drug manufacturers in the administrative region to do a good job in the revision, labeling and replacement of the OTC drug instructions of Pudilan Xiaoyan tablets (capsules) It is hereby announced Attachment of State Food and Drug Administration on November 1, 2018: 1 Model of over-the-counter drug Manual of Pudilan Xiaoyan tablet 2 Model of over-the-counter drug Manual of Pudilan Xiaoyan capsule