Raltegravir Viatris: Withdrawal of the marketing authorisation application
raltegravir potassium
Table of contents
Overview
The company Viatris withdrew its application for a marketing authorisation of Raltegravir Viatris for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
The company withdrew the application on 22 February 2023.
Key facts
Name |
Raltegravir Viatris |
Product number |
EMEA/H/C/005813 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/02/2023 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Raltegravir Viatris (PDF/589.37 KB)
Adopted
First published: 05/04/2023
EMA/CHMP/116101/2023 -
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Withdrawal letter: Raltegravir Viatris (PDF/125.58 KB)
First published: 31/03/2023 -
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Questions and answers on the withdrawal of application for the marketing authorisation of Raltegravir Viatris (raltegravir) (PDF/121.33 KB)
First published: 31/03/2023
Last updated: 21/04/2023
EMA/141471/2023 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').