The Ministry of Health of the Russian Federation has registered the drug product “Morphine, solution for oral administration, 2 mg/mL, 6 mg/mL, 20 mg/mL” manufactured by FSUE Moscow Endocrine Plant of the Ministry of Industry and Trade of Russia, marketing authorization No. LP-006023, reference day 13.01.2020.
The specified product belongs to the analgesic narcotic drug pharmacotherapeutic group, is immediate release non-invasive morphine drug product, recommended for use starting from the age of 18.
Indication for the use of the drug product is acute and chronic pain syndrome of strong intensity, not relieve by other drug products. The product efficiency and safety profile has been proved by clinical studies with respect to the reference product “Morphine, film-coated tablets, 5 mg, 10 mg”.
The specified product is a liquid dosage form in monodoses, which is an advantage over the other routes of morphine administration. Given the social significance of making the drug products available to Russian patients in the process of providing them with palliative medical care, the procedure of marketing authorization of the drug product “Morphine, solution for oral administration, 2 mg/mL, 6 mg/mL, 20 mg/mL” is performed by the Ministry of Health of Russia in the shortest time possible.
The project has been implemented as part of embodiment of the activity plan (“Road map”) “Promotion of the availability of narcotic drugs and psychotropic substances for medical use”, approved by the Decree of the Russian Federation Government No. 1403-r dd. 01.07.2016. The Ministry of Industry and Trade of the Russian Federation provided the FSUE Moscow Endocrine Plant with the subsidy to compensate a part of expenditures related to conducting clinical studies of the mentioned drug. Owing to the co-work of the Ministry of Industry and Trade of the Russian Federation, the Ministry of Health of Russia and FSUE Moscow Endocrine Plant of the Ministry of Industry and Trade of the Russian Federation, those patients receiving palliative care will get access in Q1 of 2020 to the new form of the anaesthetic drug product “Morphine”, which is the “golden standard” of the World Health Organisation in pain relieving.
Comment type is not specified in the component properties.