Sondelbay: Withdrawal of the marketing authorisation application
teriparatide
Table of contents
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.
Key facts
Name |
Sondelbay |
Product number |
EMEA/H/C/005233 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
19/06/2020 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Sondelbay (PDF/716.48 KB)
Adopted
First published: 28/09/2020
EMA/379279/2020 -
List item
Withdrawal letter: Sondelbay (PDF/17.36 KB)
First published: 26/06/2020 -
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 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').