According to Sotex’s press cervice, Cereton, the company’s nootropic drug, was approved by the Ministry of Health of the Russian Federation for use in children from March 16. The drug’s registration certificate states that Cereton in capsules can be used in the treatment of mild and moderate cognitive impairment caused by traumatic brain injury and/or hemorrhagic stroke (including the recovery period and long-term consequences of the above conditions).
Cereton has become the only choline alfoscerate therapy on the Russian market approved for the treatment of children with cognitive impairments, the company said.
“To support the expansion of indications, we presented the results of a double-blind placebo-controlled multicenter randomized trial of efficacy, safety and tolerability of Cereton (capsules and oral solution) in children aged 6-17 years with mild and moderate cognitive impairment. The study showed that therapy with the use of the Cereton is superior to placebo in the treatment of children with post-traumatic and post-hemorrhagic cognitive impairments of mild and moderate severity,” the report says.
The duration of treatment is determined by the doctor with due account for the clinical picture and the course of the disease. Sotex also mentioned that a course of treatment can be up to 60 days.