Axumin: Withdrawal of the application to change the marketing authorisation

fluciclovine (18F)

Overview

Blue Earth Diagnostics Ireland Ltd withdrew its application for the use of Axumin in the diagnosis of glioma (a type of brain tumour) and the continuing assessment of the disease.

The company withdrew the application on 11 February 2020.

  • List item

    Questions and answers on the withdrawal of application to change the marketing authorisation for Axumin (fluciclovine (18F)) (II-11) (PDF/131.11 KB) (updated)


    First published: 28/02/2020
    Last updated: 25/03/2020
    EMA/88420/2020

  • Key facts

    Name
    Axumin
    Product number
    EMEA/H/C/004197
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    21/05/2017
    International non-proprietary name (INN) or common name
    • fluciclovine (18F)
    Active substance
    • Fluciclovine (18F)
    Date of withdrawal
    11/02/2020
    Company making the application
    Blue Earth Diagnostics Ireland Ltd
    Withdrawal type
    Post-authorisation

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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