Heplisav:

Withdrawal of the marketing authorisation application

hepatitis B surface antigen

Table of contents

Overview

On 10 February 2014, Dynavax International B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Heplisav, for the prevention of hepatitis B infection.

Key facts

Name
Heplisav
Product number
EMEA/H/C/002603
International non-proprietary name (INN) or common name
  • hepatitis B surface antigen
Active substance
  • hepatitis B surface antigen
Date of withdrawal
10/02/2014
Company making the application
Dynavax International B.V.
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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