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Search What's new Find all the latest news and updates published on this website in one place. FAQs Find answers to the most frequently asked questions we receive. Latest news List item 25/11/2021 COVID-19 Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11. The vaccine, developed by BioNTech and Pfizer, is already approved for use in... List item 24/11/2021 A vision for use of real-world evidence in EU medicines regulation Enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe by 2025: this is the vision of European regulators as outlined in an... List item 23/11/2021 COVID-19 EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19 EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). Lagevrio, which is being developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, is intended... List item 23/11/2021 2011-2020: More than 40% decrease in sales of antimicrobials for use in animals The annual report on the European Surveillance of Veterinary Antimicrobial Consumption published by EMA shows that European countries have substantially reduced the use of antimicrobials in animals. According to data from the 25 countries that... List item 22/11/2021 COVID-19 EMA evaluating data on booster dose of COVID-19 Vaccine Janssen EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose to people aged 18 years and older. EMA’s human medicines committee (CHMP) will carry out an... List item 19/11/2021 COVID-19 EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19 EMA’s human medicines committee (CHMP) has issued advice on the use of Lagevrio (also known as molnupiravir or MK 4482) for the treatment of COVID-19. The medicine, which is currently not authorised in the EU, can be used to treat adults with COVID-... 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