Germany· DE-A57-7b39c1a43a9ebf72
Buprenorphin/Naloxon G.L. Pharma
A medicinal product containing buprenorphine, naloxone, registered in Germany by G.L. Pharma Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Buprenorphine, Naloxone
- Manufacturer
- G.L. Pharma Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
Buprenorphine, naloxone 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 freeA A H Pharmaceuticals 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
- 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
- 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 EMA Article 57 (European Union). 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/83198b7d-d3e2-4cab-91ad-e581e37623ba GET /v1/drugs/83198b7d-d3e2-4cab-91ad-e581e37623ba?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.
{
"pzn": null,
"route": "Sublingual Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Buprenorphine, Naloxone",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about buprenorphine, naloxone.
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.