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Four drugs including ambroxol hydrochloride sustained-release tablets and lactulose oral solution were converted into over-the-counter drugs

 Last Update: 2021-08-03
 Source: Internet
 Author: User

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People's Daily Online, Beijing, July 15 (Reporter Hongli Sun) According to the official website of the State Food and Drug Administration, the State Food and Drug Administration issued an announcement a few days ago that ambroxol hydrochloride sustained-release tablets, lactulose oral solution, boulardii yeast powder and amino sulfate Potassium glucose capsules are converted from prescription drugs to over-the-counter drugs

The State Food and Drug Administration stated that the relevant drug marketing authorization holders are requested to submit to the provincial drug regulatory authority for the record of the revision of the insert sheet and to amend the contents of the insert sheet in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations before April 11, 2022.

In addition, the contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented according to the original approval documents

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