SecreFlo: Withdrawal of the marketing authorisation application

secretin human

Overview

On 15 August 2012, Repligen Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for SecreFlo, intended for use in the detection of duct abnormalities in the pancreas.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for SecreFlo (secretin human) (PDF/56.64 KB)


    First published: 24/09/2012
    Last updated: 24/09/2012
    EMA/CHMP/602611/2012

  • Key facts

    Name
    SecreFlo
    Product number
    EMEA/H/C/002027
    International non-proprietary name (INN) or common name
    • secretin human
    Active substance
    • secretin human
    Date of withdrawal
    15/08/2012
    Company making the application
    Repligen Europe Limited
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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