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.

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

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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