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Medicines
Spain
Buprenorphine

AEMPS 2020

Buprenorphine, Naloxone

Suboxone 4 MG/1 MG Pelicula Sublingual

4,32 mg + 1,22 mg pelicula sublingualSpainAuthorisedAuthorised 29 Oct 2020

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

SuboxoneEuropean UnionAuthorised

SuboxoneCanada · 16 MG + 4 MG · Tablet · Indivior UK LimitedSame brand
SuboxoneCanada · 2 MG + 0.5 MG · Tablet · Indivior UK LimitedSame brand
SuboxoneCanada · 12 MG + 3 MG · Tablet · Indivior UK LimitedSame brand
SuboxoneEuropean Union · Indivior Europe LimitedSame brand
SuboxoneCroatiaSame brand
Suboxone, tablet voor sublinguaal gebruik 16 mg/4 mgNetherlands · Tablet voor sublinguaal gebruik · Indivior Europe LimitedSame brand

More with the same substance on this register

Buprenorfina/Naloxona Aurovitas 2 MG/0,5 MG Comprimidos Sublinguales EfgBuprenorphine + Naloxone · 2,16 mg + 0,61 mg · comprimido sublingualSpain
Buprenorfina/Naloxona Aurovitas 8 MG/2 MG Comprimidos Sublinguales EfgBuprenorphine + Naloxone · 8,64 mg + 2,44 mg · comprimido sublingual

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

🇳🇱Suboxone, tablet voor sublinguaal gebruik 2,0 mg/0,5 mgNetherlands · Tablet voor sublinguaal gebruik · Indivior Europe LimitedSame brand

🇳🇱Suboxone, tablet voor sublinguaal gebruik 8,0 mg/2,0 mgNetherlands · Tablet voor sublinguaal gebruik · Indivior Europe LimitedSame brand

🇺🇸SuboxoneUnited States · 2MG BASE; 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 8MG BASE; 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet · IndiviorSame brand

🇺🇸SuboxoneUnited States · 12MG BASE; 3MG BASE, 2MG BASE; 0.5MG BASE, 4MG BASE; 1MG BASE … · film · IndiviorSame brand

🇭🇷Bulnexo 2 mg/0,5 mg sublingvalne tableteCroatia · sublingvalna tableta · Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, SlovenijaSame form

🇭🇷Bulnexo 8 mg/2 mg sublingvalne tableteCroatia · sublingvalna tableta · Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, SlovenijaSame form

🇮🇹BunamolItaly · Compressa sublinguale · L. Molteni & C. Dei F.Lli Alitti Societa' di Esercizio S.P.A.Same form

🇮🇹Buprenorfina e Naloxone EthypharmItaly · Compressa sublinguale · EthypharmSame form

🇮🇹Buprenorfina e Naloxone G.L. PharmaItaly · Compressa sublinguale · G.L. Pharma GMBHSame form

🇳🇿Buprenorphine Naloxone BNMNew Zealand · Tab sublingual 8 mg with naloxone 2 mgSame form

🇳🇿Buprenorphine Naloxone BNMNew Zealand · Tab 2 mg with naloxone 0.5 mgSame form

🇳🇿Buprenorphine Naloxone BNMNew Zealand · Tab sublingual 2 mg with naloxone 0.5 mgSame form

🇷🇸Bulnexo®Serbia · 8mg+2mg · sublingvalna tableta · Alkaloid D.O.O. BeogradSame form

🇷🇸Bulnexo®Serbia · 2mg+0.5mg · sublingvalna tableta · Alkaloid D.O.O. BeogradSame form

🇷🇸Bupensan duoSerbia · 2mg+0.5mg · sublingvalna tableta · PMC Group DOO BeogradSame form

🇺🇸Buprenorphine Hydrochloride and Naloxone HydrochlorideUnited States · 0.7MG BASE; 0.18MG BASE, 1.4MG BASE; 0.36MG BASE, 11.4MG BASE; 2.9MG BASE … · tablet · HikmaSame form

🇪🇺ZubsolvEuropean Union · Accord Healthcare S.L.U.Same substance

🇹🇼Desud plus 2/0.5mg Sublingual TabletsTaiwan · 舌下錠 · 美時化學製藥股份有限公司Same substance

🇹🇼Desud plus 4/1mg Sublingual TabletsTaiwan · 舌下錠 · 美時化學製藥股份有限公司Same substance

🇹🇼Desud Plus Sublingual TabletsTaiwan · 舌下錠 · 美時化學製藥股份有限公司Same substance

Packs

Pack	Code	Status
SUBOXONE 4 MG/1 MG PELICULA SUBLINGUAL, 7 películas	729295
SUBOXONE 4 MG/1 MG PELICULA SUBLINGUAL, 28 películas	729296

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substances: Buprenorphine, Naloxone
Strength: 4,32 mg + 1,22 mg
Dosage form: pelicula sublingual
Route: Vía bucal (buccal use), VÍA SUBLINGUAL
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 29 Oct 2020
Registration: 1060359010
Marketing authorisation holder: Indivior Europe Limited
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/06/359

🇪🇸Spain

AEMPSSuboxone 12 MG/3 MG Pelicula SublingualBuprenorphine + Naloxone · 12,96 mg + 3,66 mg · pelicula sublingual🇪🇸Spain

AEMPSSuboxone 2 MG/0,5 MG Comprimidos SublingualesBuprenorphine + Naloxone · 2 mg + 0,5 mg · comprimido sublingual🇪🇸Spain

AEMPSSuboxone 2 MG/0,5 MG Comprimidos SublingualesBuprenorphine + Naloxone · 2 mg + 0,5 mg · comprimido sublingual🇪🇸Spain

AEMPSSuboxone 2 MG/0,5 MG Pelicula SublingualBuprenorphine + Naloxone · 2,16 mg + 0,61 mg · pelicula sublingual🇪🇸Spain

AEMPSSuboxone 8 MG/2 MG Comprimidos SublingualesBuprenorphine + Naloxone · 8 mg + 0,5 mg · comprimido sublingual🇪🇸Spain

AEMPSSuboxone 8 MG/2 MG Comprimidos SublingualesBuprenorphine + Naloxone · 8 mg + 2 mg · comprimido sublingual🇪🇸Spain

AEMPSSuboxone 8 MG/2 MG Pelicula SublingualBuprenorphine + Naloxone · 8,64 mg + 2,44 mg · pelicula sublingual🇪🇸Spain

AEMPSZubsolv 0,7 MG/0,18 MG Comprimidos SublingualesBuprenorphine + Naloxone · 0,77 mg + 0,2175 mg · comprimido sublingual🇪🇸Spain

AEMPSZubsolv 1,4 MG/0,36 MG Comprimidos SublingualesBuprenorphine + Naloxone · 1,54 mg + 0,435 mg · comprimido sublingual🇪🇸Spain

AEMPSZubsolv 11,4 MG/2,9 MG Comprimidos SublingualesBuprenorphine + Naloxone · 12,32 mg + 3,48 mg · comprimido sublingual🇪🇸Spain