In June this year, the Ministry of Health of the Slovak Republic approved an additional supply of original Polyoxidonium® tablets produced by the Russian pharmaceutical company Petrovax. Polyoxidonium® will be used for the prevention of coronavirus infection in medical workers and for immunological support of patients with COVID-19.
The import of the medicine into an EU country is carried out under special approval of the department requiring no additional registration. The scope of delivery is 10,000 packages.
Petrovax has been exporting Polyoxidonium® to Slovakia for over 15 years. The volume of deliveries of the Russian product is increasing annually due to wide demand.
In 2017, Petrovax received a report on the positive results of the Post Authorization Safety Study of Polyoxidonium® (PASS) in the EU (Slovakia)12. This is the first experience of post-marketing research of original Russian medicine in Europe as a whole. During the pandemic, the demand for an immunomodulator in the country has increased, in 2020 Polyoxidonium® was included in the clinical guidelines for the treatment of patients with coronavirus. Slovakia was also among the countries participating in the International Multicenter Clinical Trial to evaluate the effectiveness of the medicine in the treatment of COVID-19 in hospitalized patients.
This is not a first decision of the Ministry of Health of Slovakia regarding additional export of Polyoxidonium®. In February 2021, the Ministry permitted Petrovax to deliver 5,000 packages of Polyoxidonium® (tablets) to the L. Pasteur University Hospital for the prevention and treatment of coronavirus infection. The new agreement in June doubled the volume of supplies.
According to the document, the therapeutic use of the product is allowed in medical institutions in Slovakia for the purpose of immunoprophylaxis of coronavirus infection in medical workers and the treatment of patients with COVID-19.
Polyoxidonium® (INN: Azoximer bromide) is an original Russian medication, which has been widely used in Russian clinical practice and exported to foreign countries for over 20 years. The medication has been registered and being supplied to 10 countries.
In early February 2021, Petrovax completed the recruitment of patients for an international multicenter clinical trial (IMCT) of Polyoxidonium® for the treatment of moderate to severe cases of COVID-19. The study took in a total of 394 patients from Russia and Slovakia. The results of the study are expected in the summer 2021.
Polyoxidonium® has been used by medics for treating COVID-19 in Russia, the CIS countries and the EU. It is used for the preventive protection of doctors working in the “red zones”, and is also being studied in open observation programs in patients with COVID-19.