TrialSite has previously reported that the Czech Republic Ministry of Health had previously authorized the use of a limited supply of ivermectin to target COVID-19 during this latest wave of pandemic infections in this Eastern European country and part of the European Union bloc of nations. The drug was not formally registered but now is most definitely formally authorized via government authority. The Ministry of Health has issued a rule based on their legal authority to protect the public health in the context of the ongoing global pandemic. The health authority there temporarily now allows distribution, supply, and use of the unregistered human medicinal product HUVEMEC, an ivermectin-based product. The Czech Health Authority authorizes the use of 3mg tablets produced by Huvepharma from Bulgaria. In total, as TrialSite picked up on from local press and at least two discussions with locals, 5,000 packages of 10×3 mg and 5,000 packages of 30×3 mg are now authorized for use via a prescription from a licensed medical professional.
As TrialSite reported, the shipment of the ivermectin-based product went to University Hospital at St. Anne’s in Brno, which is designated as the “Coordinating Pharmacy.” In this model, the government regulatory body has authorized this hospital to serve as the distribution holder, managing the supply and distribution to other hospitals in the country.
The drug can only be prescribed to patients 18 years and up with the typical disclosures—e.g. that it isn’t registered for the COVID-19 indication. Use by pregnant women is precluded. They note that hepatic function should be monitored before and after treatment. Physicians must be aware of risks of off label use.
The national regulator is on the record: “the dose regimen was evaluated as safe and most appropriate: 0.2 mg/kg/day given on days 1, 3 and 5 and a maximum daily dose of 24 mg.”
TrialSite reported that the physician in charge of this ivermectin operation is Michal Rezek.
Ivermectin Use in EU Bloc
Now the following countries have at least temporarily authorized ivermectin: Slovakia, Macedonia and Czech Republic. The drug appears to have become more popular in Bulgaria, and a major study was announced in Hungary.
Growing demand in Portugal brings the demand for the generic drug targeting COVID-19 into Western Europe.
Call to Action: There is growing evidence as to ivermectin’s efficacy and safety as a low cost treatment for COVID-19. TrialSite is an unbiased, independent online media platform emphasizing patient and health care professional empowerment. Sign up for the newsletter—catch the TrialSite wave.