Xiidra: Withdrawal of the marketing authorisation application

Overview

Novartis Europharm Ltd withdrew its application for a marketing authorisation of Xiidra for the treatment of dry eye disease.

The company withdrew the application on 18 June 2020.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Xiidra (PDF/128.51 KB)


    First published: 26/06/2020
    Last updated: 14/07/2020
    EMA/334810/2020

  • Key facts

    Name
    Xiidra
    Product number
    EMEA/H/C/004653
    Active substance
    • Lifitegrast
    Date of withdrawal
    18/06/2020
    Company making the application
    Novartis Europharm 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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