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.

  • 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

  • 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

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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