Germany· DE-A57-13dae090aebea5a3
Buprenorphin G.L.
A medicinal product containing buprenorphine hydrochloride, 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 Hydrochloride
- 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 hydrochloride in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaADDNOKI-GEN, LDA, Caparica
- United KingdomBunov 10micrograms/hour transdermal patchesGlenmark Pharmaceuticals Europe Ltd
- United StatesBELBUCABioDelivery Sciences International Inc
- SwedenBuprefarm 10 mikrogram/timme DepotplåsterOrifarm Generics A/S
- FinlandBupaq Multidose vetVetViva Richter GmbH
- NetherlandsBuprenorfine G.L. Pharma 0,2 mg tabletten voor sublinguaal gebruikG.L. Pharma GmbH
- BelgiumBuprenorfine Sandoz 35 µg/hSandoz
- FranceBUPENSAN 2 mg, comprimé sublingualG.L. PHARMA (AUTRICHE)
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Astec, Bupensan
- Belgium · Temgesic, Transtec
- Bulgaria · Бупренорфин G.L., Бупренорфин Актавис
- Cyprus · Buvera
- Czechia · Addnok, Buprenorfin Stada
- 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 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/dcdec946-7376-4220-b0f1-a9de0d95fd62 GET /v1/drugs/dcdec946-7376-4220-b0f1-a9de0d95fd62?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 Hydrochloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about buprenorphine hydrochloride.
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.