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  • 2 indications deleted for choline alfoscerate, changes label
  • by Lee, Tak-Sun | translator Alice Kang | Jun 30, 2021 05:56am
Indication No.2 and 3 will be deleted for choline alfoscerate¡¦label change by July
MFDS orders change on 28th ¡¦need to review substitute for CA prescription and dispensing
Authorities have ordered companies to delete the No.2 and No.3 indication of the brain function enhancer choline alfoscerate, for which the clinical re-evaluations have started recently. Accordingly, the indication must be removed from the label from the 28th of next month.

Also, the Ministry of Food and Drug Safety requested doctors and pharmacists to review the need to prescribe and dispense substitute drugs for patients that use choline alfoscerate during the labeling change period.

On the 28th, the MFDS ordered a label change for 144 choline alfoscerate products. After a review of the clinical trial protocols for the reevaluation of these products, the ministry determined that that trial will be unable to a
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