Russian medicine to be supplied to Slovakia under special approval for the prevention of COVID-19

Russian medicine to be supplied to Slovakia under special approval for the prevention of COVID-19

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. “Consumption of Polyoxidonium per capita is four times higher than in Russia. It is greatly appreciated by local doctors”, says Mikhail Tsyferov, President of Petrovax Pharm.

In 2017, Petrovax received a report on the positive results of the Post Authorization Safety Study of Polyoxidonium (PASS) in the EU (Slovakia)[1][2]. 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.

Prof. Dr. Pavol Jarcuska, PhD., president of Slovak Society of Infectologists, member of the Government pandemic committee:

The medicine is well-known among the medical professionals of Slovakia and has positively proven itself. Our country already has a successful experience of using Polyoxidonium against COVID-19. I believe that the decision of the Ministry will help us in the fight against the spread of coronavirus infection.

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.

From her side Dr. Mária Soľavová, Head of the Infectious Diseases Clinic at University Hospital Trnava added:

Let me add that with our direct participation, the drug was studied within the international clinical trial, the purpose of which is to determine the safety and efficacy of Polyoxidonium against Covid-19. A huge amount of work has been done, the results of which we expect this summer.

Mikhail Tsyferov, President of Petrovax:

We highly appreciate the trust that Slovakia places in our product. We are glad to see how our cooperation with Slovakia is developing and we look forward to expanding it in the future.

For reference:

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)[3] 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.

[1] http://www.encepp.eu/encepp/viewResource.htm?id=19533

[2] https://www.futuremedicine.com/doi/abs/10.2217/imt-2017-0116

[3] http://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=daba6b25-ac75-4bd4-9f67-a800651502e6&CIPermGUID=1D24A86C-2196-46DD-86C1-C5B5C6AD0F8E

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