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    Blenrep | European Medicines Agency (EMA)

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    Overview

    The conditional marketing authorisation for Blenrep has not been renewed by the European Commission.

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    Product information

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    Latest procedure affecting product information:
    R/017

    23/02/2024

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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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    Product details

    Name of medicine

    Blenrep

    Active substance

    belantamab mafodotin

    International non-proprietary name (INN) or common name

    belantamab mafodotin

    Therapeutic area (MeSH)

    Multiple Myeloma

    Anatomical therapeutic chemical (ATC) code

    L01XC39

    Pharmacotherapeutic group

    Antineoplastic agents

    Therapeutic indication

    Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

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