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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating
    Average
    1 rating