Buvidal
buprenorphine
Table of contents
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.
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List item
Buvidal : EPAR - Medicine overview (PDF/94.36 KB)
First published: 18/12/2018
EMA/660126/2018 -
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List item
Buvidal : EPAR - Risk-management-plan summary (PDF/69.92 KB)
First published: 18/12/2018
Last updated: 16/08/2023
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 |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
20/11/2018
|
Contact address |
Ideon Science Park |
Product information
26/07/2021 Buvidal - EMEA/H/C/004651 - R/0021
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.