Iceland· IS-EU/1/06/359/005-006
Suboxone
A buprenorphin, kombinationen product containing naloxonum inn hýdróklóríð,buprenorphinum inn hýdróklóríð, registered in Iceland by Indivior Europe Limited. The same ATC class is registered in 10 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Buprenorphin, kombinationen is registered in 10 of 19 countries.
Countries holding a registration under ATC N07BC51 (buprenorphin, kombinationen), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 6 of them publish a price we can compare per daily dose
Buprenorphin, kombinationen · ATC N07BC51
10 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Naloxonum INN hýdróklóríð,Buprenorphinum INN hýdróklóríð
- Manufacturer
- Indivior Europe Limited
- Country
- Iceland (IS)
- ATC code
- N07BC51
- ATC class
- Buprenorphin, Kombinationen
- Defined daily dose
- 8 mg, SL
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Buprenorphin, kombinationen in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United Statesbuprenorphine and naloxoneHikma Pharmaceuticals USA Inc.
- CzechiaBUPENSANDUOG.L. Pharma GmbH, Lannach
- United KingdomBuprenorphine 2mg / Naloxone 500microgram sublingual tablets sugar freeAlliance Healthcare (Distribution) Ltd
- FinlandBunalictSandoz A/S
- SwedenBunalict 2 mg/0,5 mg Resoriblett, sublingualSandoz A/S
- NetherlandsBunalict 2 mg/0,5 mg, tabletten voor sublinguaal gebruikSandoz B.V.
- SpainBUPRENORFINA/NALOXONA AUROVITAS 2 MG/0,5 MG COMPRIMIDOS SUBLINGUALES EFGAurovitas Spain, S.A.U.
- IrelandBulexin 2 mg/0.5 mg sublingual tabletsPinewood Laboratories Limited
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Bupensan Duo
- Belgium · Libroxar
- Bulgaria · Булнексо
- Cyprus · Libroxar
- Czechia · Bupensanduo, Libroxar
- Germany · Bowielone, Bulnexo
- Denmark · Bunalict, Buprenorphin/Naloxon G.L. Pharma
- Estonia · Bupensanduo
- Spain · Buprenorfina/Naloxona Aurovitas
- Finland · Bunalict, Buprenorphine/Naloxone G.L. Pharma
- France · Buprenorphine / Naloxone Viatris, Buprenorphine/Naloxone Arrow
- United Kingdom (Northern Ireland) · Buprenorphine/Naloxone Ethypharm, Buprenorphine/Naloxone G.L. Pharma
- Greece · Libroxar
- Croatia · Bulnexo, Bunalict
- Hungary · Bulnexo
- Ireland · Bulexin, Buprenorphine/Naloxone Pinewood
- Italy · Bunamol, Buprenorfina E Naloxone Ethypharm
- Liechtenstein · Suboxone, Zubsolv
- Lithuania · Bupensanduo
- Luxembourg · Libroxar
- Latvia · Bupensanduo
- Malta · Libroxar
- Netherlands · Bunalict, Buprenorfine/Naloxon Viatris
- Norway · Bunalict, Suboxone
- Portugal · Buprenorfina + Naloxona Generis
- Sweden · Bunalict, Buprenorphine/Naloxone G.L. Pharma
- Slovenia · Bulnexo
- Slovakia · Bupensanduo
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of Icelandic Medicines Agency (Iceland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/4d182152-c078-4ffd-a47b-13c60ddaca0d GET /v1/drugs/4d182152-c078-4ffd-a47b-13c60ddaca0d?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Tungurótartafla",
"source": "lyfjastofnun",
"atc_raw": "N07BC51",
"marketed": false,
"strength": "16 mg/4 mg",
"ma_number": "EU/1/06/359/005-006",
"substance": "Naloxonum INN hýdróklóríð,Buprenorphinum INN hýdróklóríð",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í geðlækningum og sérfræðinga í meðferð á ópíatfíkn.",
"legal_status": "(R X Z) Eftirritunarskylt, sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "42324"
}See everything about buprenorphin, kombinationen.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.