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    Gavreto | European Medicines Agency (EMA)

    Europe Markets

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    Overview

    The marketing authorisation for Gavreto has been withdrawn at the request of the marketing-authorisation holder.

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    Product information

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    Latest procedure affecting product information:
    T/0021

    17/07/2024

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    This medicine’s product information is available in all official EU languages.
    Select ‘available languages’ to access the language you need.

     

    Product information documents contain:

    • summary of product characteristics (annex I);
    • manufacturing authorisation holder responsible for batch release (annex IIA);
    • conditions of the marketing authorisation (annex IIB);
    • labelling (annex IIIA);
    • package leaflet (annex IIIB).

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    íslenska (IS)
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    italiano (IT)
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    latviešu valoda (LV)
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    lietuvių kalba (LT)
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    magyar (HU)
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    Product details

    Name of medicine

    Gavreto

    Active substance

    pralsetinib

    International non-proprietary name (INN) or common name

    pralsetinib

    Therapeutic area (MeSH)

    Carcinoma, Non-Small-Cell Lung

    Anatomical therapeutic chemical (ATC) code

    L01EX23

    Pharmacotherapeutic group

    Antineoplastic agents

    Therapeutic indication

    Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

    Direct healthcare professional communications (DHPC)

    Further information on Gavreto

    English (EN)
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