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Ireland· IE-PA-EU/1/06/359/03-04

Suboxone 8 mg/2 mg Sublingual tablet

A buprenorphin, kombinationen product containing buprenorphine hydrochloride + naloxone hydrochloride, registered in Ireland by Indivior Europe Limited. The same ATC class is registered in 10 of our 19 countries.

ATC N07BC51

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSuboxone 8 mg/2 mg Sublingual tabletATCN07BC51REGISTER NO.IE-PA-EU/1/06/359/03-…PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about buprenorphine hydrochloride + naloxone hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose
Search buprenorphin, kombinationen products by name

Buprenorphin, kombinationen · ATC N07BC51

10 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Buprenorphine hydrochloride + NALOXONE HYDROCHLORIDE
Manufacturer
Indivior Europe Limited
Country
Ireland (IE)
ATC code
N07BC51
ATC class
Buprenorphin, Kombinationen
Defined daily dose
8 mg, SL
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/06/359/03-04

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.

All buprenorphin, kombinationen products

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
  • Iceland · Suboxone, Zubsolv
  • 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 HPRA (Ireland). 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/b23747ec-fe94-4955-8bbe-40f1822a5761
GET /v1/drugs/b23747ec-fe94-4955-8bbe-40f1822a5761?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": "Sublingual tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "N07BC",
    "N07BC51"
  ],
  "strength": null,
  "pa_number": "EU/1/06/359/03-04",
  "substances": [
    "Buprenorphine hydrochloride",
    "NALOXONE HYDROCHLORIDE"
  ],
  "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "26/09/2006",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
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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.

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