As part of execution of the decrees of the Russian Federation Government dd. 05.09.2019 No.1986-r “On alloting to the Ministry of Industry and Trade of the Russian Federation the Budgetary Allocations from the Reserve Fund in 2019” and dd. 25.09.2019 No. 2170-r “On the Import of Unregistered Psychotropic Medications to the RF for the Purpose of Providing Children with Medical Care for Vital Indications in 2019” (hereinafter as the Decree), on the import to the territory of the Russian Federation of unregistered medications containing psychotropic substances. On December 6, 2019, FSUE "Moscow Endocrine Plant” (hereinafter as the Enterprise), which is under jurisdiction of the Ministry of Industry and Trade of Russia, imported in full 380 packs of the medicinal product with the international non-proprietary name (hereinafter as INN) Midazolam (trade name - “Bukkolam”) in oromucosal (buccal) solution dosage form - 2.5 mg/0,5 ml No. 4, 7.5 мг/1,5 мл No.4, 10 мг/2 мл No.4.
The specified medicinal product is intended for relieving a sudden and long-lasting convulsionary attack in infants, children and adolescents from 3 months to 18 years of age.
Apart from the import of the required medicinal products to the Russian Federation, the work has been organised by the Enterprise together with the Ministry of Health of Russia with regional healthcare bodies on the shipment of psychotropic medications to the subjects of the Russian Federation.
Donation (assignation) agreements were concluded by the Enterprise with 12 subjects of the Russian Federation that notified about the necessity in dosage forms of the product with the INN Midazolam unregistered in the Russian Federation.
The product with the INN Midazolam will be shipped in full within the next week to the following subjects of the Russian Federation: The Belgorod region, the Krasnodar region, Moscow, the Moscow region, the Nizhny Novgorod region, the Oryol region, the Republic of Bashkortostan, St. Petersburg, the Saratov region, the Smolensk region, the Chuvash Republic, the Yaroslavl region.
As part of setting up own production of the imported medicinal products by the Ministry of Industry and Trade of the Russian Federation, together with the Enterprise, the medicinal product “Midazolam, solution for oromucosal (buccal) use in doses of 2.5 mg/ml, 5 mg/ml, 7.5 mg/ml, 10 mg/ml” has been put into production. The approximate term of start of production of the specified medicinal product is QIV, 2020.
Earlier, as part of execution of decrees the Enterprise imported 7 620 packs of the medicinal product with the INN Clobazam (trade name - Urbanil) and 3100 packs - with the INN Diazepam (trade name - Diazepam Desitin).
Comment type is not specified in the component properties.