Tookad: Withdrawal of the application to change the marketing authorisation
Table of contents
Steba biotech S.A. withdrew its application to modify the grading system and biopsy requirements for use of Tookad in the treatment of prostate cancer and extend its use from low-risk to intermediate-risk patients.
The company withdrew the application on 14 December 2021.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').