Buvidal: Withdrawal of the application to change the marketing authorisation
buprenorphine
Table of contents
Overview
Camurus AB withdrew its application for the use of Buvidal to treat chronic (long-term) pain in people with dependence on opioids.
The company withdrew the application on 13 February 2023.
Key facts
Name |
Buvidal |
Product number |
EMEA/H/C/004651 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
20/11/2018 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
13/02/2023 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal assessment report for Buvidal (II-17) (PDF/4.17 MB)
Adopted
First published: 14/06/2023
EMA/88938/2023 -
List item
Withdrawal letter : Buvidal (II-17) (PDF/60.84 KB)
First published: 24/02/2023 -
List item
Questions and answers on the withdrawal of application to change the marketing authorisation for Buvidal (buprenorphine) (PDF/145.71 KB)
First published: 24/02/2023
Last updated: 14/06/2023
EMA/76139/2023 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').