Federal State Unitary Enterprise Endopharm subordinated to the Ministry of Industry and Trade of Russia received a Marketing Authorization for Ketamine-ENDOPHARM, a new medicinal product for veterinary use, dosage form – solution for injections of 100 mg/ml in 5 ml vials. Marketing Authorization 77-3-24.22-4941 No. PVR-3-24.22/03775.
Pharmacotherapeutic group of the medicinal product: agent for non-inhalation general anesthesia (anesthetic drug). Ketamine belongs to the psychotropic substances of Schedule II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.
“Ketamine-ENDOPHARM” is prescribed to dogs and cats for pain relief and general non-inhalation anesthesia in combination with butorphanol and medetomidine or in combination with xylazine.
The medicinal product can be used in cats in monotherapy for immobilization and for minor operations that do not require muscle relaxation.
“Ketamine-ENDOPHARM” is intended only for use by veterinary specialists in hospitals and is not for sale through the pharmacy (retail) network.
Currently, authorized organizations of the constituent entities are accepting applications for the purchase of ketamine for veterinary use from hospitals in order to submit them to the Ministry of Industry and Trade of Russia and further determine the need of veterinary hospitals in this medicine during distribution of the medicine to them, in the manner established by the Decree of the Government of the Russian Federation dd. October 30, 2021 No. 1871 “On approval of the Rules for the distribution, sale and release of narcotic drugs and psychotropic substances, as well as the sale and release of their precursors, and the declaration of certain acts and certain provisions of certain acts of the Government of the Russian Federation invalid”. It should be noted that information on the needs of veterinary hospitals taken into account in the medicine distribution plan annually approved by the Ministry of Industry and Trade of Russia is updated quarterly.
A special subsection “Specialists in veterinary medicine” is developed on the site https://www.endopharm.ru/, where registered users can ask questions and consult with specialists of FSUE “Endopharm”, who have been working with narcotic drugs, psychotropic and potent substances for many years, as well as with experts from a specially formed Expert Council on Legal Drug Trafficking, the activities of which are provided by an autonomous non-profit organization established by FSUE “Endopharm”. The problems of issuing a license for the circulation of narcotic drugs and psychotropic substances for veterinary organizations are already clarified in the section.
The requirements of the Good Manufacturing Practice rules of the Eurasian Economic Union (EEU GMP) for the production of veterinary medicinal products are the same as for the production of medicinal products for human use. In November 2022, FSUE “ENDOPHARM” received the report on the conformity of the manufacturer of medicinal products for veterinary use to the EEU GMP requirements.
Ketamine-ENDOPHARM is the second medicinal product for veterinary use included in the Enterprise’s portfolio. Earlier FSUE “ENDOPHARM” brought the veterinary medicine “Tramvet®, solution for intramuscular injection, 50 mg/ml” (INN tramadol) to the domestic market, an analgesic with a combined mechanism of action; the number of packages produced will reach one hundred thousand by the end of the year.
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