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Medicines
Spain
Buprenorphine

AEMPS 2018

Buprenorphine, Naloxone

Zubsolv 2,9 MG/0,71 MG Comprimidos Sublinguales

3,08 mg + 0,87 mg comprimido sublingualSpainAuthorisedAuthorised 27 Jul 2018

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.

ZubsolvEuropean UnionAuthorised

ZubsolvEuropean Union · Accord Healthcare S.L.U.Same brand
ZubsolvCroatiaSame brand
ZubsolvItaly · Compressa sublinguale · Accord Healthcare, S.L.U.Same brand
Zubsolv 0,7 mg/0,18 mg, tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Accord Healthcare S.L.U.Same brand
Zubsolv 1,4 mg/0,36 mg, tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Accord Healthcare S.L.U.Same 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.

🇳🇱

Zubsolv 11,4 mg/2,9 mg, tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Accord Healthcare S.L.U.

Same brand

🇺🇸ZubsolvUnited States · 0.7MG BASE; 0.18MG BASE, 1.4MG BASE; 0.36MG BASE, 11.4MG BASE; 2.9MG BASE … · tablet · Edenbridge PharmsSame brand

🇨🇦PMS-Buprenorphine-NaloxoneCanada · 2 MG + 0.5 MG · Tablet · Pharmascience INCSame form

🇨🇦PMS-Buprenorphine-NaloxoneCanada · 8 MG + 2 MG · Tablet · Pharmascience INCSame form

🇨🇦SuboxoneCanada · 2 MG + 0.5 MG · Tablet · Indivior UK LimitedSame form

🇭🇷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

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

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

🇺🇸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 form

🇪🇺SuboxoneEuropean Union · Indivior Europe LimitedSame 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
ZUBSOLV 2,9 MG/0,71 MG COMPRIMIDOS SUBLINGUALES, 7 comprimidos	722396
ZUBSOLV 2,9 MG/0,71 MG COMPRIMIDOS SUBLINGUALES, 28 comprimidos	722398

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: 3,08 mg + 0,87 mg
Dosage form: comprimido sublingual
Route: vía sublingual
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 27 Jul 2018
Registration: 1171233011
Marketing authorisation holder: Accord Healthcare S.L.U.
Procedure: EU centralised
Supply: Diagnóstico Hospitalario. Psicótropos
EU number: EU/1/17/1233

🇪🇸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 4 MG/1 MG Pelicula SublingualBuprenorphine + Naloxone · 4,32 mg + 1,22 mg · pelicula sublingual🇪🇸Spain

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

AEMPSSuboxone 8 MG/2 MG Comprimidos SublingualesBuprenorphine + Naloxone · 8 mg + 0,5 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