Sixmo

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buprenorphine

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

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.

This EPAR was last updated on 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 monitoringAdditional 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
Marketing-authorisation holder
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
Date of issue of marketing authorisation valid throughout the European Union
19/06/2019
Contact address

Strada Statale 67
Tosco Romagnola
Firenze 50018
Scandicci
Italy

Product information

19/06/2019 Sixmo - EMEA/H/C/004743 -

Contents

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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.

Assessment history

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