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  • Highlights of the safety committee: October 2023
    PRAC highlights October 2021
    MEDICINES |COMMITTEES

    Highlights of the safety committee: October 2023

  • Highlights of the safety committee: October 2023
    PRAC highlights October 2021
    MEDICINES |COMMITTEES

    Highlights of the safety committee: October 2023

    At its monthly meeting, EMA's safety committee, the PRAC, discussed new safety information for medicines containing omega-3-acid ethyl esters

  • New ACT EU video released
    ACT EU slider
    Clinical Trials |Regulatory

    New ACT EU video released

  • New ACT EU video released
    ACT EU slider
    Clinical Trials |Regulatory

    New ACT EU video released

    Watch a video to learn about how the Accelerating Clinical Trials in the EU (ACT EU) initiative is transforming the way clinical trials are initiated, designed, and run

  • CHMP highlights: September 2023
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    MEDICINES |COMMITTEES

    CHMP highlights: September 2023

  • CHMP highlights: September 2023
    CHMP slider image
    MEDICINES |COMMITTEES

    CHMP highlights: September 2023

    EMA's human medicines committee (CHMP) recommended nine new medicines for approval in the EU at its September 2023 meeting.

  • EMA cooperation with HTA bodies in the EU
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    HTA Regulation |EUnetHTA

    EMA cooperation with HTA bodies in the EU

  • EMA cooperation with HTA bodies in the EU
    Slider for EMA cooperation with HTA bodies in the EU
    HTA Regulation |EUnetHTA

    EMA cooperation with HTA bodies in the EU

    The EMA-EUnetHTA cooperation is coming to an end, but preparations are continuing for the implementation of the regulation on health technology assessment.

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Latest news

  • List item
    29/09/2023

    Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023

    New safety information for Omega-3-acid ethyl esters The PRAC agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product information for medicines containing omega-3-acid ethyl esters. These...

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    15/09/2023

    Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies

    Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology...

  • List item
    15/09/2023

    EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep

    On 21 September, the company that markets Blenrep asked for re-examination of the CHMP opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its recommendation and issue a final recommendation. Once the re-examination has...

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    15/09/2023 COVID-19

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023

    Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting. The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for the...

  • List item
    15/09/2023

    EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

    EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a...

  • List item
    14/09/2023 COVID-19

    Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5

    EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant. The vaccine — known as Spikevax XBB.1.5 — is to be used for preventing COVID-19 in adults and children from 6...

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