Ambrisentan Zentiva: Withdrawal of the marketing authorisation application

ambrisentan

Overview

On 29 April 2019, Zentiva, k.s. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ambrisentan Zentiva, for the treatment of pulmonary arterial hypertension (high blood pressure in the arteries of the lungs).

Key facts

Name
Ambrisentan Zentiva
Product number
EMEA/H/C/004955
International non-proprietary name (INN) or common name
  • ambrisentan
Active substance
  • ambrisentan
Date of withdrawal
29/04/2019
Company making the application
Zentiva, k.s.
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 (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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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