Roctavian: Withdrawal of the marketing authorisation application

Valoctocogene roxaparvovec


BioMarin International Limited withdrew its application for a marketing authorisation of Roctavian for the treatment of severe haemophilia A.

The company withdrew the application on 4 November 2020.

Key facts

Product number
International non-proprietary name (INN) or common name
  • Valoctocogene roxaparvovec
Active substance
  • Valoctocogene roxaparvovec
Date of withdrawal
Company making the application
BioMarin International Limited
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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