SIXMO Implant Ref.[28026] Active ingredients: Buprenorphine

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A, Strada Statale 67, 50018 Scandicci (Firenze), Italy

Product name and form

Sixmo 74.2 mg implant.

Pharmaceutical Form

Implant.

White/Off-white to pale yellow, rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.

Qualitative and quantitative composition

Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Buprenorphine

Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the ÎŒ (mu) and Îș (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the ÎŒ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence.

List of Excipients

Ethylene vinyl acetate copolymer

Pack sizes and marketing

Each Sixmo implant is packaged individually into a PET/LDPE/Alu/LDPE-peelable foil laminate sachet.

Implant kit: 4 Sixmo implants with 1 applicator.

Marketing authorization holder

L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A, Strada Statale 67, 50018 Scandicci (Firenze), Italy

Marketing authorization dates and numbers

EU/1/19/1369/001

20 June 2019

Drugs

Drug Countries
SIXMO Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.