Federal State Unitary Enterprise “Endopharm” subordinated to the Ministry of Industry and Trade of Russia received a Marketing Authorization for a new medicine Clobazam, tablets, 10 mg. Marketing Authorization LP-No. (001352)-(RG-RU).
The medicine is indicated for use in adults and children 3+ under the following conditions:
symptomatic treatment of acute and chronic conditions of tension, agitation and anxiety;
epilepsy (as additional therapy in patients who have not achieved remission during therapy with one or more antiepileptic drugs).
Clobazam belongs to the Schedule of psychotropic substances (Schedule III) of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.
The Government of the Russian Federation indicated to the importance of introducing domestic medicines with an international non-proprietary name (INN) Clobazam into the production.
Preparations with INN Clobazam are in high demand for providing medical care to adults and children 3+ suffering from convulsive syndrome of various etiologies. At the same time, they were limitedly available for patients in need in Russia in a certain period of time due to the lack of state registration in the country.
Since 2019, FSUE “Endopharm”, in accordance with acts of the Government of the Russian Federation, has been importing essential medicines not registered in Russia in the manner prescribed by law and in the amount determined by the Ministry of Health of Russia or the health authorities of the constituent entities of the Russian Federation. This allowed, from 2019 to the present, quick ensuring the availability of medicines for patients who need them for medical reasons and eliminate the prerequisites for violations of the procedure for the circulation of psychotropic medicines established by the legislation of the Russian Federation by citizens.
The medicine “Clobazam, tablets, 10 mg” produced by FSUE “Endopharm” is the first domestic generic of the original medication with the INN Clobazam (brand name – “Frisium”). The medicine will become available to patients at the end of the first quarter of 2023.
In 2020, due to the joint effective interaction and support of the federal executive authorities, the Enterprise introduced into production the medicines “Midazolam, buccal solution, 2.5 mg/ml, 5 mg/ml” and “Sibazon, rectal solution, 2 mg/ml, 4 mg/ml”, which are already used to provide medical care to children with convulsive syndrome.
According to the assessment made, the production facilities of FSUE “Endopharm” will allow satisfying the need for these medicines previously imported exclusively from abroad by 100%, and providing domestic high-quality, effective and safe medicines to patients with status epilepticus, including pediatric ones, in all constituent entities of the Russian Federation.
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