Orathecin: Withdrawal of the marketing authorisation application

Rubitecan

Overview

On 19 January 2006, EuroGen Pharmaceuticals Ltd officially notified the Agency's Committee for Medicinal Products for Human Use (CHMP) of its decision to withdraw its application for marketing authorisation for the medicinal product orathecin (rubitecan). The indication applied for was the treatment of patients with advanced or metastatic pancreatic cancer.Orathecin was designated as an orphan medicinal product on 10 June 2003.

  • List item

    Questions and answers on withdrawal of marketing application for Orathecin (PDF/34.85 KB)


    First published: 23/01/2006
    Last updated: 23/01/2006
    EMEA/282451/2008

  • Key facts

    Name
    Orathecin
    Product number
    EMEA/H/C/000608
    International non-proprietary name (INN) or common name
    • Rubitecan
    Active substance
    • Rubitecan
    Date of withdrawal
    19/01/2006
    Company making the application
    EuroGen Pharmaceuticals Ltd
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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