Alendronic Acid / Colecalciferol Mylan: Withdrawal of the marketing authorisation application

alendronic acid / colecalciferol

Overview

On 27 May 2016, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Alendronic Acid/Colecalciferol Mylan, for the treatment of postmenopausal osteoporosis in women at risk of vitamin D deficiency.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Alendronic Acid/Colecalciferol Mylan (alendronic acid and colecalciferol) (PDF/75.05 KB)


    First published: 24/06/2016
    Last updated: 02/02/2017
    EMA/354096/2016

  • Key facts

    Name
    Alendronic Acid / Colecalciferol Mylan
    Product number
    EMEA/H/C/004172
    International non-proprietary name (INN) or common name
    • alendronic acid / colecalciferol
    Active substance
    • alendronate sodium trihydrate
    • colecalciferol
    Date of withdrawal
    27/05/2016
    Company making the application
    Mylan S.A.S.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating