Sixmo

Withdrawn

This medicine's authorisation has been withdrawn

buprenorphine

Overview

On 19 June the European Commission withdrew the marketing authorisation for the implant Sixmo (buprenorphine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Sixmo was granted marketing authorisation in the EU on 20 June 2019 for substitution treatment for opioid dependence in clinically stable adults who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2024.

Patients currently receiving treatment with Sixmo should have their implant removed at the end of the cycle and should be transitioned back to their previous sublingual buprenorphine dose to ensure continued treatment in accordance with the recommendations already included in the approved SmPC of the product.

Several therapeutic alternatives are also available, as either buprenorphine alone or buprenorphine in combination with naloxone, in different pharmaceutical forms.

Sixmo : EPAR - Overview

Reference Number: EMA/251834/2019

Sixmo : EPAR - Risk-management-plan summary

Product information

Sixmo : EPAR - Product information

Sixmo : EPAR - All authorised presentations

Product details

• Name of medicine:
  Sixmo
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004743
• Marketing authorisation holder:
  L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.

  Strada Statale 67; Tosco Romagnola; Firenze 50018; Scandicci; Italy

• Opinion adopted:
  26/04/2019
• Marketing authorisation issued:
  19/06/2019
• Withdrawal of marketing authorisation:
  19/06/2025
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Sixmo : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Sixmo : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/266482/2019

CHMP summary of opinion for Sixmo

Adopted Reference Number: EMA/CHMP/215656/2019