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  • ICMRA workshop on adapted COVID-19 vaccines
    ICMRA workshop on adapted vaccines
    COVID-19 |International collaboration

    ICMRA workshop on adapted COVID-19 vaccines

  • ICMRA workshop on adapted COVID-19 vaccines
    ICMRA workshop on adapted vaccines
    COVID-19 |International collaboration

    ICMRA workshop on adapted COVID-19 vaccines

    Global regulators agree on key principles to adapt COVID-19 vaccines to tackle virus variants

  • Start of review for Imvanex
    Monkeypox Imvanex vaccine
    Monkeypox |Vaccine

    Start of review for Imvanex

  • Start of review for Imvanex
    Monkeypox Imvanex vaccine
    Monkeypox |Vaccine

    Start of review for Imvanex

    EMA reviews data to extend use of smallpox vaccine Imvanex against monkeypox and recommends importing US vaccine to the EU as temporary measure

  • Call for companies to register their i-SPOC
    i-SPOC registration for companies
    EXTENDED MANDATE |SHORTAGES

    Call for companies to register their i-SPOC

  • Call for companies to register their i-SPOC
    i-SPOC registration for companies
    EXTENDED MANDATE |SHORTAGES

    Call for companies to register their i-SPOC

    Marketing authorisation holders are invited to register their Industry Single Point of Contact on shortages in EMA’s IRIS platform. Deadline for registration is 2 September 2022

  • CHMP highlights: June 2022
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    MEDICINES |COMMITTEES

    CHMP highlights: June 2022

  • CHMP highlights: June 2022
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    MEDICINES |COMMITTEES

    CHMP highlights: June 2022

    EMA's human medicines committee (CHMP) recommended 9 new medicines for approval in the EU at its June 2022 meeting

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Latest news

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    01/07/2022 COVID-19

    Global regulators agree on key principles on adapting vaccines to tackle virus variants

    On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop co-chaired by the European Medicines Agency (EMA) and the US Food and...

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    30/06/2022

    Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU

    EMA and the European Food Safety Authority (EFSA) published a report on the development of a harmonised approach to the assessment of the dietary exposure of people to residues of veterinary medicines, feed additives and pesticides in food of animal...

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    28/06/2022

    Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability

    Marketing authorisation holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major...

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    28/06/2022

    Monkeypox: EMA starts review for Imvanex

    EMA’s human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. Imvanex is currently authorised in the EU for the prevention of smallpox in...

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    24/06/2022 COVID-19

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022

    Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its June 2022 meeting. The CHMP recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated,...

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    24/06/2022

    First gene therapy to treat severe haemophilia A

    EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors (auto-antibodies...

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