Veraseal: Withdrawal of the marketing authorisation application

human fibrinogen / human thrombin

Overview

On 29 September 2015, Instituto Grifols S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for marketing authorisation of VeraSeal, which was intended to help stop bleeding during vascular (blood vessel) surgery when standard surgical methods for controlling bleeding are insufficient.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for VeraSeal (human fibrinogen / human thrombin) (PDF/109.85 KB)


    First published: 23/10/2015
    Last updated: 23/10/2015
    EMA/679015/2015

  • Key facts

    Name
    Veraseal
    Product number
    EMEA/H/C/003914
    International non-proprietary name (INN) or common name
    • human fibrinogen / human thrombin
    Active substance
    • human fibrinogen
    • human thrombin
    Date of withdrawal
    29/09/2015
    Company making the application
    Instituto Grifols, S.A. 
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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