Hyalograft C autograft:

Withdrawal of the marketing authorisation application

characterised viable autologous chondrocytes expanded in vitro, seeded and cultured on a hyaluronan-based scaffold

Overview

On 14 January 2013, Anika Therapeutics S.r.l. officially notified the European Medicines Agency that it wishes to withdraw its application for a marketing authorisation for Hyalograft C autograft, for repairing defects in the cartilage of the femoral condyles and trochlea (the end of the thigh bone that forms part of the knee) caused by sudden or repetitive trauma.

  • List item

    Questions and answers on withdrawal of the marketing authorisation application for Hyalograft C autograft (characterised viable autologous chondrocytes expanded in vitro, seeded and cultured on a hyaluronan-based scaffol... (PDF/76.94 KB)


    First published: 26/02/2013
    Last updated: 14/05/2013
    EMA/52320/2013

  • Key facts

    Name
    Hyalograft C autograft
    Product number
    EMEA/H/C/002657
    International non-proprietary name (INN) or common name
    • characterised viable autologous chondrocytes expanded in vitro, seeded and cultured on a hyaluronan-based scaffold
    Active substance
    • characterised viable autologous chondrocytes expanded in vitro, seeded and cultured on a hyaluronan-based scaffold
    Date of withdrawal
    14/01/2013
    Withdrawal type
    Initial authorisation

    All documents

    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.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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