The Ministry of Health of Russia has registered the medicinal product “Fentanyl transdermal therapeutic system 12.5 mcg/h, 25 mcg/h, 50 mcg/h, 75 mcg/h and 100 mcg/h manufactured by FSUE Moscow Endocrine Plant. Marketing authorization No. LP-004366.
The medicinal product belongs to the analgesic narcotic drug pharmacotherapeutic group and is the first domestic fentanyl product in the dosage form for transdermal administration. The product is on the the Vital and Essential Drugs List (VED).
Indication for the use of the medicinal product is severe chronic pain, which is appropriately revealed only by means of opioid analgesics. Fentanyl in form of TTS is used as a means of palliative care in oncologic patients.
The project has been implemented as part of the import substitution program and the action plan “Promotion of the availability of narcotic drugs and psychotropic substances for medical use” (“Road Map”), approved by the Decree of the Russian Federation Government No. 1403-r dd. 01.07.2016.
It is scheduled in November, 2017 to produce the first product commercial batches in the facility for production of domestic transdermal patches.
This way, the Enterprise will perform the full cycle of production of Fentanyl in form of TTS - from home-made substance to the finished dosage form.
Comment type is not specified in the component properties.