Sixmo
buprenorphine
Table of contents
Overview
Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine. It contains the active substance buprenorphine.
Sixmo is used in adults who are already stable while taking buprenorphine under the tongue (no more than 8 mg/day), and who are also receiving medical, social and psychological support.
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List item
Sixmo : EPAR - Overview (PDF/78.68 KB)
First published: 02/07/2019
EMA/251834/2019 -
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Sixmo : EPAR - Risk-management-plan summary (PDF/125.62 KB)
First published: 02/07/2019
Authorisation details
Product details | |
---|---|
Name |
Sixmo
|
Agency product number |
EMEA/H/C/004743
|
Active substance |
Buprenorphine hydrochloride
|
International non-proprietary name (INN) or common name |
buprenorphine
|
Therapeutic area (MeSH) |
Opioid-Related Disorders
|
Anatomical therapeutic chemical (ATC) code |
N07BC01
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
19/06/2019
|
Contact address |
Strada Statale 67 |
Product information
16/02/2023 Sixmo - EMEA/H/C/004743 - IAIN/0015
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
Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.