DepoCyte: Withdrawal of the application to change the marketing authorisation



On 28 June 2006, SkyePharma PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for DepoCyte 50 mg suspension for injection, in the intrathecal treatment of solid tumour neoplastic meningitis.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for DepoCyte (PDF/37.45 KB)

    First published: 29/06/2006
    Last updated: 29/06/2006

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • cytarabine
    Active substance
    • cytarabine
    Date of withdrawal
    Company making the application
    Pacira Limited
    Withdrawal type

    All documents

    Related content

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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