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EMA starts evaluating Spikevax in young children
COVID-19 |VaccinesEMA starts evaluating Spikevax in young children
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EMA starts evaluating Spikevax in young children
COVID-19 |VaccinesEMA starts evaluating Spikevax in young children
EMA starts evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to children aged 6 to 11
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Update on molnupiravir
COVID-19 |TreatmentsUpdate on molnupiravir
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Update on molnupiravir
COVID-19 |TreatmentsUpdate on molnupiravir
EMA starts a review to support possible national decisions on early use of oral antiviral molnupiravir, ahead of authorisation
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PRAC highlights November 2021
MEDICINES |COMMITTEESPRAC highlights November 2021
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PRAC highlights November 2021
MEDICINES |COMMITTEESPRAC highlights November 2021
Outcomes from the November meeting: updates on the safety of COVID-19 vaccines and a medicine for blood cancers
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EMA organises its 4th public meeting on COVID-19
COVID-19 |EventEMA organises its 4th public meeting on COVID-19
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EMA organises its 4th public meeting on COVID-19
COVID-19 |EventEMA organises its 4th public meeting on COVID-19
The meeting will take place on 25 November 2021 and will update European citizens on the approval and safety monitoring of COVID-19 vaccines and therapeutics in the EU
Latest news
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List item10/11/2021 COVID-19
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to children aged 6 to 11. Spikevax is a vaccine for preventing COVID-19, currently authorised for use in people aged 12 years and older. It contains...
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List item08/11/2021 COVID-19
COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
EMA starts review to support possible national decisions on early use The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on the need for additional guidance on COVID-19 treatments in light of rising rates of...
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List item08/11/2021
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 2021
The Committee adopted by consensus a positive opinion for a marketing authorisation application for CircoMax (porcine circovirus vaccine (inactivated recombinant)) , from Zoetis Belgium SA, a new vaccine for the active immunisation of pigs against...
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List item02/11/2021 COVID-19
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of COVID-19 developed by Eli Lilly Netherlands BV, after the company informed the Agency that it was withdrawing from the process. Since March 2021,...
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List item29/10/2021 COVID-19
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
PRAC assessing further data on risk of myocarditis and pericarditis with mRNA vaccines EMA’s safety committee (PRAC) is assessing further data providing more information on the risk of myocarditis and pericarditis following vaccination with COVID-19...
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List item29/10/2021
Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IA IN variations for 2021 no later than Tuesday 30 November 2021. This will enable EMA to acknowledge the validity of the submissions before...
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