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Full assessment report for COVID-19 Vaccine AstraZeneca
COVID-19 |VaccinesFull assessment report for COVID-19 Vaccine AstraZeneca
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Full assessment report for COVID-19 Vaccine AstraZeneca
COVID-19 |VaccinesFull assessment report for COVID-19 Vaccine AstraZeneca
The full assessment report for COVID-19 Vaccine AstraZeneca is available, together with the product information in all official EU languages
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Authorisation application for COVID-19 Vaccine Janssen
COVID-19 |VaccinesAuthorisation application for COVID-19 Vaccine Janssen
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Authorisation application for COVID-19 Vaccine Janssen
COVID-19 |VaccinesAuthorisation application for COVID-19 Vaccine Janssen
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V.
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PRAC highlights February 2021
MEDICINES |COMMITTEESPRAC highlights February 2021
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PRAC highlights February 2021
MEDICINES |COMMITTEESPRAC highlights February 2021
The PRAC carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines, including COVID-19 treatments and vaccines.
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EMA preparing guidance to tackle COVID-19 variants
COVID-19 |VaccinesEMA preparing guidance to tackle COVID-19 variants
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EMA preparing guidance to tackle COVID-19 variants
COVID-19 |VaccinesEMA preparing guidance to tackle COVID-19 variants
EMA is developing regulatory guidance for manufacturers planning changes to the existing COVID-19 vaccines in the European Union
Latest news
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List item19/02/2021
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 2021
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for Credelio Plus ( lotilaner and milbemycin oxime combination) from Elanco GmbH, a new antiparasitic...
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List item16/02/2021 COVID-19
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen,...
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List item12/02/2021 COVID-19
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
Review of amfepramone medicines started EMA has started a review of obesity medicines that contain amfepramone. These medicines are authorised in some EU countries as treatment for patients with obesity (body mass index of at least 30 kg/m 2 ) in...
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List item12/02/2021 COVID-19
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
EMA’s human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID‑19 vaccine being developed by CureVac AG. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical...
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List item10/02/2021 COVID-19
EMA preparing guidance to tackle COVID-19 variants
EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new virus variants. In order to consider options for additional testing and development of vaccines that are effective against new virus...
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List item10/02/2021 COVID-19
Clarification on Sputnik V vaccine in the EU approval process
The European Medicines Agency has to date not received an application for a rolling review or a marketing authorisation for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-...
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