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Full assessment report for COVID-19 Vaccine ModernaCOVID-19 |Vaccines
Full assessment report for COVID-19 Vaccine Moderna
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Full assessment report for COVID-19 Vaccine ModernaCOVID-19 |Vaccines
Full assessment report for COVID-19 Vaccine Moderna
EMA has published the full assessment report for COVID-19 Vaccine Moderna, the second COVID-19 vaccine authorised in the EU.
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Human medicines: highlights of 2020MEDICINES |Highlights
Human medicines: highlights of 2020
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Human medicines: highlights of 2020MEDICINES |Highlights
Human medicines: highlights of 2020
In 2020, EMA recommended 97 medicines for authorisation. Read more about the Agency’s key recommendations on the authorisation and safety monitoring of medicines in our visual overview.
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Veterinary medicines: highlights of 2020MEDICINES |Highlights
Veterinary medicines: highlights of 2020
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Veterinary medicines: highlights of 2020MEDICINES |Highlights
Veterinary medicines: highlights of 2020
EMA recommended 20 veterinary medicines for authorisation in 2020. Check out our visual overview of key recommendations on the authorisation and safety monitoring of veterinary medicines.
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ICMRA statement for healthcare professionals publishedCOVID-19 |International collaboration
ICMRA statement for healthcare professionals published
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ICMRA statement for healthcare professionals publishedCOVID-19 |International collaboration
ICMRA statement for healthcare professionals published
EMA has endorsed a statement developed by ICMRA to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of COVID-19 vaccines.
Latest news
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List item22/01/2021
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021
CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025 CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a type II variation application for Exzolt (fluralaner ) to...
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List item21/01/2021
Veterinary medicines: highlights of 2020
EMA has published an overview of its key recommendations of 2020 regarding the authorisation and safety monitoring of veterinary medicines. In 2020, EMA recommended 20 medicines for marketing authorisation, including 13 with a new active substance...
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List item21/01/2021
Human medicines: highlights of 2020
EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use. In 2020, EMA recommended 97 medicines for marketing authorisation. Of these, 39 had a new active substance which...
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List item19/01/2021 COVID-19
Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe,...
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List item15/01/2021
Cyberattack on EMA - update 5
The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines have been leaked on the internet. This included internal/confidential email correspondence dating...
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List item15/01/2021 COVID-19
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
First monthly summary safety report for COVID-19 vaccine Comirnaty Starting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports submitted monthly by marketing authorisations holders of COVID-19 vaccines. The first such...
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Services & databases
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Account Management portal
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eSubmission
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EudraVigilance (human)
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EU Veterinary Medicinal Product Database
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Suspected adverse drug reactions database
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Clinical data
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SPOR data management services
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Service Desk
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IRIS platform
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Public register of parallel distribution notices
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European Vaccination Information Portal