Ambrisentan Zentiva: Withdrawal of the marketing authorisation application
Table of contents
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).
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').