Buvidal

RSS

buprenorphine

Authorised
This medicine is authorised for use in the European Union.

Overview

Buvidal is a medicine used to treat dependence on opioid (narcotic) drugs such as heroin or morphine.

Buvidal is used in adults and adolescents aged over 16 years who are also receiving medical, social and psychological support.

Buvidal contains the active substance buprenorphine and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Buvidal is given in a different way.

The reference medicine for Buvidal is Subutex. While Subutex is available as sublingual tablets (tablets to be placed under the tongue), Buvidal is available as a solution for injection under the skin.

This EPAR was last updated on 21/10/2021

Authorisation details

Product details
Name
Buvidal
Agency product number
EMEA/H/C/004651
Active substance
buprenorphine
International non-proprietary name (INN) or common name
buprenorphine
Therapeutic area (MeSH)
Opioid-Related Disorders
Anatomical therapeutic chemical (ATC) code
N07BC01
Publication details
Marketing-authorisation holder
Camurus AB
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
20/11/2018
Contact address

Ideon Science Park
SE-223 70 Lund
Sweden

Product information

23/09/2021 Buvidal - EMEA/H/C/004651 - II/0015/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

Assessment history

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