Keytruda: Withdrawal of the application to change the marketing authorisation

pembrolizumab

Overview

Merck Sharp & Dohme B.V. withdrew its application for the use of Keytruda in the treatment of cancer of the oesophagus (food pipe).

The company withdrew its application on 10 December 2019.

Key facts

Name
Keytruda
Product number
EMEA/H/C/003820
Date of issue of market authorisation valid throughout the European Union (if applicable)
17/07/2015
International non-proprietary name (INN) or common name
  • pembrolizumab
Active substance
  • Pembrolizumab
Date of withdrawal
10/12/2019
Company making the application
Merck Sharp & Dohme B.V.
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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