The Federal State Unitary Enterprise Moscow State Endocrine Plant obtained the registration certificate for the drug Morphine, 10 mg, 30 mg, 60 mg and 100 mg extended-release, film-coated tablets.
The Ministry of Health of the Russian Federation registered the domestic drug “Morphine, 10 mg, 30 mg, 60 mg and 100 mg extended-release film-coated tablets”, produced by the Moscow State Endocrine Plant.
The Registration certificate No. LP-005473, the registration date 04.17.2019
The drug belongs to the pharmacotherapeutic group of analgesic drugs and is the first Russian generic of the drug "MSTContinus®, 10 mg, 30 mg, 60 mg and 100 mg extended-release film-coated tablets".
The drug is included in the list of Vital and Essential Drugs.
It is included in the List II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.
The drug is used for prolonged relief of severe and chronic pain.
It is recommended for use from the age of 18 years.
The extension of the method of use of the drug for use in pediatric patients is planned in 2020.
The efficacy and safety profile is confirmed in comparative clinical studies with the drug "MSTContinus®, 10 mg, 30 mg, 60 mg and 100 mg extended-release film-coated tablets".
The project was implemented as part of import substitution and the implementation of the Action Plan (“road map”) “Improvement of the availability of narcotic drugs and psychotropic substances for medical use”, approved by the order of the Government of the Russian Federation from 01.07.2016 No. 1403-r.
The Enterprise plans to launch the first commercial series of the drug in June 2019.
Comment type is not specified in the component properties.