The Government of the Russian Federation instructed the Moscow Endocrine Plant to provide children and adolescents with psychotropic drugs nonregistered in the Russian Federation: Diazepam for rectal use, 5 mg and 10 mg, Midazolam for buccal use, 2.5 mg, 5 mg, 7.5 mg, 10 mg, Clobazam tablets, 5 mg and 10 mg, Phenobarbital, syrup for internal use, 100 ml and 400 ml. The Ministry of Health of Russia has formed a need for these drugs, based on the conclusions on the prescription of drugs of the relevant medical commissions of medical organizations, confirming the need of children in nonregistered psychotropic drugs. FSUE Moscow Endocrine Plant works with foreign manufacturers of this group of drugs; requests have been sent to more than 20 companies from Bangladesh, Belgium, Bulgaria, Great Britain, Germany, Italy, Canada, the USA, Finland, France, Switzerland, and with the aim of organization as soon as possible of the purchase and import of a limited batch of the drugs nonregistered in Russia to provide medically indigent children and adolescents. The Enterprise will also distribute unregistered drugs containing psychotropic substances to the constituent entities of the Russian Federation in accordance with the distribution plan for narcotic drugs, psychotropic substances and their precursors approved by the Ministry of Industry and Trade of Russia. Deliveries to the constituent entities of the Russian Federation are scheduled to begin in the 4th quarter of 2020. At the same time, the Enterprise continues to organize clinical trials of its own drugs: "Diazepam", a solution for rectal administration, 2.5 mg/1.25 ml, 5 mg/2.5 ml, 10 mg/2.5 ml, 20 mg/5 ml, the introduction period is 2020, use in children from the 1 year; "Midazolam", a solution for oromucosal (buccal) use, 2.5 mg/ml, 5 mg/ml, 7.5 mg/ml, 10 mg/ml, introduction period is 2020, use in children from the 1 year.
Provision of children and adolescents with the pharmaceutical products not registered in the Russian Federation
26 August 2019
Comment type is not specified in the component properties.