Graspa: Withdrawal of the marketing authorisation application

asparaginase

Overview

On 22 June 2018, Erytech Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia (ALL).

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Graspa (L-asparaginase) (PDF/69.89 KB)


    First published: 29/06/2018
    Last updated: 29/06/2018
    EMA/431413/2018

  • Key facts

    Name
    Graspa
    Product number
    EMEA/H/C/004736
    International non-proprietary name (INN) or common name
    • asparaginase
    Active substance
    • asparaginase
    Date of withdrawal
    22/06/2018
    Company making the application
    ERYTECH Pharma S.A.
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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