Sondelbay: Withdrawal of the marketing authorisation application

teriparatide

Overview

Accord Healthcare S.L.U. withdrew its application for a marketing authorisation of Sondelbay for the treatment of osteoporosis (a disease that makes bones fragile).

The company withdrew the application on 19 June 2020.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Sondelbay (teriparatide) (PDF/135.58 KB)


    First published: 26/06/2020
    Last updated: 28/09/2020
    EMA/338421/2020

  • Key facts

    Name
    Sondelbay
    Product number
    EMEA/H/C/005233
    International non-proprietary name (INN) or common name
    • teriparatide
    Active substance
    • teriparatide
    Date of withdrawal
    19/06/2020
    Company making the application
    Accord Healthcare S.L.U.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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