Prohippur: Withdrawal of the marketing authorisation application

sodium benzoate

Overview

On 3 April 2018, Lucane Pharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Prohippur, for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation for Prohippur (sodium benzoate) (PDF/126.13 KB)

    Adopted

    First published: 27/04/2018
    Last updated: 27/04/2018
    EMA/258015/2018

  • Key facts

    Name
    Prohippur
    Product number
    EMEA/H/C/004150
    International non-proprietary name (INN) or common name
    • sodium benzoate
    Active substance
    • Sodium benzoate
    Date of withdrawal
    03/04/2018
    Company making the application
    Lucane Pharma
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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