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European regulator issues guidelines for the use of coronavirus pills

According to the EMA’s Committee on Human Medicines (CHMP), the drug, which is currently not approved in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19. The drug should be administered as soon as possible after the diagnosis of COVID-19 and within five days after the onset of symptoms. The medicine is produced in the form of capsules.

“The EMA has issued these guidelines to support national authorities that can decide on the possible early use of a drug prior to marketing authorization, for example in an emergency, in light of rising infection and mortality rates due to COVID-19 in the EU.” the message says.

At the same time, the drug is not recommended for pregnant women and women who may become pregnant and do not use effective contraception.

Women who may become pregnant should use effective contraception during treatment and for four days after the last dose of Lagevrio. Breastfeeding should be discontinued during treatment and for four days after treatment. have shown that high doses of Lagevrio can affect fetal growth and development, “the EMA said.

Research on the drug in the EU continues, the regulator said.

Lagevrio tablets (molnupiravir) approved for use in the UK.

Context:

Molnupiravir is a development of the American pharmaceutical companies Ridgeback Biotherapeutics and Merck Sharp & Dohme.

Merck became the first company to report the results of trials of anti-coronavirus pills. But other companies, notably Pfizer, are also now develop similar drugs.

Until now, there have been no special drugs for COVID-19, with this disease being carried out mainly symptomatic treatment.

In August this year, Minister of Health Viktor Lyashko said that Ukraine could receive revolutionary direct-acting drug from COVID-19. According to him, from one of the manufacturers Ukraine is in the six countries that will receive the medicine in the first place.

An outbreak of coronavirus infection began at the end of 2019 in China. 11 March 2020 WHO declared the spread of coronavirus a pandemic… By data American Johns Hopkins University, in the world 256.5 million cases of COVID-19 have been confirmed, almost 5.1 million people have died.

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