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  • Full assessment report for COVID-19 Vaccine AstraZeneca
    COVID-19 vaccine - marketing authorisation slider
    COVID-19 |Vaccines

    Full assessment report for COVID-19 Vaccine AstraZeneca

  • Full assessment report for COVID-19 Vaccine AstraZeneca
    COVID-19 vaccine - marketing authorisation slider
    COVID-19 |Vaccines

    Full 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

  • Authorisation application for COVID-19 Vaccine Janssen
    COVID-19 Astrazeneca vaccine - conditional marketing application slider
    COVID-19 |Vaccines

    Authorisation application for COVID-19 Vaccine Janssen

  • Authorisation application for COVID-19 Vaccine Janssen
    COVID-19 Astrazeneca vaccine - conditional marketing application slider
    COVID-19 |Vaccines

    Authorisation 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.

  • PRAC highlights February 2021
    PRAC highlights
    MEDICINES |COMMITTEES

    PRAC highlights February 2021

  • PRAC highlights February 2021
    PRAC highlights
    MEDICINES |COMMITTEES

    PRAC 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.

  • EMA preparing guidance to tackle COVID-19 variants
    COVID-19 - EMA's opinion on variants slider
    COVID-19 |Vaccines

    EMA preparing guidance to tackle COVID-19 variants

  • EMA preparing guidance to tackle COVID-19 variants
    COVID-19 - EMA's opinion on variants slider
    COVID-19 |Vaccines

    EMA 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

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Latest news

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    19/02/2021

    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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    16/02/2021 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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    12/02/2021 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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    12/02/2021 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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    10/02/2021 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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    10/02/2021 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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