The Ministry of Health of the Russian Federation recommended to amend the instructions to owners and manufacturers of drugs with INN ginkgo biloba extract. A corresponding letter has been published in the State Register of Medicines (GRLS), “FV” reports.
“The document states the need to develop a single version of the Indications section in the instructions for the drug in oral form. The changes apply to both prescription and over-the-counter products. The instructions of prescription drugs must include the indication of Dyscirculatory encephalopathy of various etiologies (developed as a result of stroke or brain trauma in elderly patients),” the publication writes.
Three items must be included in the instructions for OTC ginkgo products. In particular, this concerns symptomatic treatment of cognitive impairment and tinnitus.
The basis for the requirements of the Ministry of Health is the message of the Federal State Budgetary Institution “Research Center for the Expert Examination of Medical Devices”.
The GRLS includes about 17 registration certificates for drugs containing the extract.
