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Belgium· BE-AMP-SAM545280-00

Libroxar 2 mg - 0.5 mg

A buprenorphin, kombinationen product containing buprenorphine hydrochloride, registered in Belgium by Laboratoires S.M.B.. The same ATC class is registered in 10 of our 19 countries.

ATC N07BC51

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedLibroxar 2 mg - 0.5 mgATCN07BC51REGISTER NO.BE-AMP-SAM545280-00PACKS LISTED3CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about buprenorphine 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Buprenorphine Hydrochloride
Manufacturer
Laboratoires S.M.B.
Country
Belgium (BE)
ATC code
N07BC51
ATC class
Buprenorphin, Kombinationen
Defined daily dose
8 mg, SL
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

2 priced
  • be_apb
    4132056
    EUR 9.58
  • be_apb
    4132064
    EUR 21.3
  • be_apb
    7727159

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Buprenorphin, kombinationen in 16 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 27 EEA countries. Names it is sold under:

  • Austria · Astec, Bupensan
  • Bulgaria · Бупренорфин G.L., Бупренорфин Актавис
  • Cyprus · Buvera
  • Czechia · Addnok, Buprenorfin Stada
  • Germany · Acimaphin, Acinorphin
  • Denmark · Buprefarm, Bupremyl
  • Estonia · Buprenorphine G.L. Pharma
  • Spain · Buprenorfina Andrómaco, Buprenorfina Sandoz
  • Finland · Buprefarm, Bupremyl
  • France · Bupensan, Buprenorphine Arrow
  • United Kingdom (Northern Ireland) · Addnok, Bunov
  • Greece · Buprenal, Buvera
  • Croatia · Buprenorfin Alkaloid, Buprenorfin Sandoz
  • Ireland · Buprenorphine Activase Pharmaceuticals, Buprenorphine Morningside Healthcare
  • Iceland · Buprenorphine Alvogen, Buprenorphine Neuraxpharm
  • Italy · Buprenorfina Molteni, Buprenorfina Sandoz
  • Liechtenstein · Buprenorphine Neuraxpharm, Buvidal
  • Luxembourg · Temgesic, Temgesic Sublingualis
  • Latvia · Buprenorphine G.L. Pharma
  • Malta · Buprenorphine Aspire Pharma (Malta), Natzon
  • Netherlands · Buprenorfine, Buprenorfine 1a Pharma
  • Norway · Bugnanto, Buprefarm
  • Poland · Bunondol, Bunorfin
  • Portugal · Buprenorfina, Buprenorfina Aurovitas
  • Sweden · Buprefarm, Buprenorfin Actavis
  • Slovenia · Addnok, Buprenorfin Alkaloid-Int
  • Slovakia · Bupretec, Noprex

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 FAMHP / AFMPS (Belgium). 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/dc1ffbc1-2864-41fc-baa5-5e470b4710db
GET /v1/drugs/dc1ffbc1-2864-41fc-baa5-5e470b4710db?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Libroxar  2 mg - 0.5 mg",
  "name_fr": "Libroxar  2 mg - 0.5 mg",
  "name_nl": "Libroxar  2 mg - 0.5 mg",
  "amp_code": "SAM545280-00",
  "strengths": [
    "2.1600",
    "2.0000",
    "0.6100",
    "0.5000",
    "0.1300",
    "43.7100",
    "29.7400",
    "0.7500"
  ],
  "pack_count": 5,
  "substances": [
    "Buprenorphine Hydrochloride",
    "Buprenorphine",
    "Naloxone Hydrochloride Dihydrate",
    "Naloxone",
    "Disodium Edetate",
    "Lactose Monohydrate",
    "Mannitol",
    "Acesulfame Potassium"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Buprenorphine, Combinations",
  "authorisation_numbers": [
    "BE545280"
  ]
}
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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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