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Specifically, it falls under the category S0: Non-Approved Substances

Cerebrolysin has the largest clinical evidence base, including randomized controlled trials (CAPTAIN I and II), cohort studies, and a meta-analysis spanning 8,749 patients

Where Its ApprovedAnd Why Not in the US Cerebrolysin is approved for treating stroke, traumatic brain injury, and/or dementia in Austria, Germany, Russia, China, South Korea, and approximately 50 other countries across Europe and Asia

10.1016/j.ejphar.2019.01.030 106 SeverM.KlicekR.RadicB.BrcicL.ZoricicI.DrmicD.et al (2009)

Solubility: Highly hydrophilic and soluble

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