Buvidal: Withdrawal of the application to change the marketing authorisation

buprenorphine

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
  • buprenorphine
Active substance
  • buprenorphine
Date of withdrawal
13/02/2023
Company making the application
Camurus AB
Withdrawal type
Post-authorisation

Related content

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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