Restaysis: Withdrawal of the marketing authorisation application

ciclosporin

Overview

On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Restaysis (ciclosporin) (PDF/73.18 KB)


    First published: 01/06/2018
    Last updated: 01/06/2018
    EMA/275525/2018

  • Key facts

    Name
    Restaysis
    Product number
    EMEA/H/C/004229
    International non-proprietary name (INN) or common name
    • ciclosporin
    Active substance
    • ciclosporin
    Date of withdrawal
    25/04/2018
    Company making the application
    Allergan Pharmaceuticals International 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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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