FSUE Endopharm, in accordance with the instructions of the Government of the Russian Federation and the import substitution strategy of the Ministry of Industry and Trade of Russia, is introducing a drug with INN Clobazam, in the dosage form of a 10 mg tablet, necessary to provide sick children with generalized tonic, clonic and tonic and clonic convulsions with psychotropic drugs.
The decision to introduce the drug was made in 2019 based on the results of a meeting chaired by T.A. Golikova, Deputy Prime Minister of the Russian Federation.
In 2020, the Enterprise introduced “Midazolam, buccal solution, 2.5 mg/ml, 5 mg/ml”, “Sibazon, rectal solution, 2 mg/ml, 4 mg/ml”, used in children and fully covering the need for these medicines previously imported exclusively from abroad.
The drugs with INN Clobazam are in great demand for providing medical care to children suffering from convulsive syndrome of various etiologies. At the same time, their availability for patients in a certain period of time turned out to be limited due to the lack of state registration in Russia.
Responding to appeals from socially oriented non-profit organizations, the Government of the Russian Federation allocated a subsidy and authorized FSUE Endopharm to systematically import essential medicines not registered in Russia in the manner prescribed by law and in the amount determined by the Russian Ministry of Health. This made it possible to quickly ensure the availability of medicines for patients who need them for medical reasons and stop the prerequisites for violations by citizens of the procedure for the circulation of psychotropic medicines established by the legislation of the Russian Federation.
In the period from 2019 to mid-2021, FSUE Endopharm, in pursuance of the Executive Decrees of the Government of the Russian Federation, purchased, imported and delivered the drug Urbanil (INN - Clobazam), capsules No. 30, 5 mg, tablets No. 30, 10 mg, manufactured by Sanofi, France in the amount of 29,734 packages.
For the Company, the introduction of these drugs is not a commercial project, but an exclusively social mission aimed at providing the most vulnerable segments of the population with high-quality and affordable medicines, as well as implementing the country's drug safety policy.
The medicinal product Clobazam, tablets, 10 mg, developed by the Company, is a generic drug of the original drug Frizium (INN - Clobazam) manufactured by Sanofi, France, which is currently being imported by the Company as an official distributor. In 2021, FSUE “Endopharm” imported 6,912 packages of Frizium registered in the Russian Federation (INN - Clobazam), tablets No. 100, 10 mg, into the country.
At the beginning of 2022, taking into account the fact that the medicinal product belongs to the list III of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, the employees of the FSBI “Scientific Center for Expert Evaluation of Medicinal Products” of the Ministry of Health of Russia successfully carried out a pharmaceutical expert evaluation of the quality of the medicinal product “Clobazam, tablets 10 mg” as part of the procedure for its state registration on the territory of the Enterprise.
We hope to be able to commercialize the domestically produced medicinal product Clobazam, 10 mg tablets from the second half of 2022, which allows us to cover the need of seriously ill patients, including pediatric patients with status epilepticus, by 100% and provide all regions of the Russian Federation with a domestic drug, which is now purchased abroad.
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