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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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 | |
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Name |
Sixmo
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Agency product number |
EMEA/H/C/004743
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Active substance |
Buprenorphine hydrochloride
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International non-proprietary name (INN) or common name |
buprenorphine
|
Therapeutic area (MeSH) |
Opioid-Related Disorders
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Anatomical therapeutic chemical (ATC) code |
N07BC01
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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 |
2
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Date of issue of marketing authorisation valid throughout the European Union |
19/06/2019
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Contact address |
Product information
27/11/2020 Sixmo - EMEA/H/C/004743 - N/0004
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.