The Ministry of Health of the Russian Federation has registered the medicinal product “Morphine, film-coated tablets, 5 mg and 10 mg” produced by FSUE Moscow Endocrine Plant.
Marketing authorisation No. LP-005012, registration date 28/08/2018.
The medicinal product belongs to the analgesic narcotic drug pharmacotherapeutic group and is the first Russian immediate release non-invasive morphine medicinal product.
Indication for the use of the medicinal product is:
Acute and chronic pain syndrome of strong intensity, not relieved by other medicinal products.
The medicinal product is recommended for administration since 18 years of age.
Efficiency and safety profile has been approved by clinical studies
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 Enterprise plans to release first product commercial batches in September of 2018.
Comment type is not specified in the component properties.