FSUE Moscow Endocrine Plant under the jurisdiction of the Ministry of Industry and Trade of Russia, pursuant to the order of the Government of the Russian Federation dated March 5, 2020 No. 230-r, purchased and imported a batch of the medicine not registered in the Russian Federation corresponding to the international non-proprietary name (INN) Clobazam for treatment of epilepsy in adults and children from the age of 6 up.
Within the framework of the contract signed with the manufacturer JSC Sanofi Vinthrop Industry (France), the Enterprise purchased and imported the following dosage forms:
Urbanil (INN - Clobazam) 5 mg capsules No. 30 in the amount of 500 packages;
Urbanil (INN - Clobazam) 10 mg tablets No. 2x15 in the amount of 2500 packages.
Medicines are intended for shipment to authorized organizations in 38 constituent entities of the Russian Federation, determined by the Ministry of Health of Russia.
Drugs with INN Clobazam are in great demand for medical care to children suffering from convulsive syndrome of various ethiology. At the same time, their availability for patients at a certain period of time was limited due to the absence of marketing authorization in Russia.
In response to the appeals of socially oriented non-profit organizations, the Government of the Russian Federation allocated a subsidy and authorized the FSUE Moscow Endocrine Plant import systematically necessary medicines not registered in Russia in the manner prescribed by law and in the amount determined by the Ministry of Health of Russia. This made it possible to ensure promptly the availability of medicines for patients who need them for medical reasons and to stop the preconditions for violations by citizens of the procedure for the circulation of psychotropic drugs established by the legislation of the Russian Federation.
In addition, the Government of the Russian Federation instructed the Ministry of Health of Russia to collaborate with manufacturers concerning market authorization of INN Clobazam medicines with the consequence that the FSUE Moscow Endocrine Plant will import Frisium registered in the Russian Federation (INN - Clobazam) as an official distributor.
Until the registered medicines with INN Clobazam enter the civil circulation in Russia, the need of the domestic health care system for them will be provided by the FSUE Moscow Endocrine Plant at the expense of imported unregistered drugs.
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Federal State Unitary Enterprise Moscow Endocrine Plant imported 3000 packages of the Unregistered Medicine with INN Clobazam for Treatment of Patients with Epilepsy
23 March 2021
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