Germany· DE-A57-bdcf69c702650a99
Bupivacain Hyperbar
A medicinal product containing bupivacaine hydrochloride ph.eur., registered in Germany by Grindeks.
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
- Bupivacaine Hydrochloride Ph.Eur.
- Manufacturer
- Grindeks
- 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
Bupivacaine hydrochloride ph.eur. in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United States0.25% BUPIVACAINE HClHF Acquisition Co LLC, DBA HealthFirst
- CzechiaBUPIVACAINE GRINDEKSAS GRINDEKS, Riga
- United KingdomBupivacain Sintetica 40mg/ml (4%) solution for injection ampoulesImported (Switzerland)
- SwitzerlandBupivacain 5 mg/ml hyperbar Sintetica, soluzione iniettabileSintetica SA
- FinlandBicainOrion Corporation
- NetherlandsBupivacaïne Accord 2,5 mg/ml oplossing voor injectieAccord Healthcare B.V.
- BelgiumBupivacaine Accord Healthcare 2.5 mg/mlAccord Healthcare
- SwedenBupivacaine Baxter 2,5 mg/ml Injektionsvätska, lösningBaxter Holding B.V.
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Bucain®, Bupivacain Aguettant
- Belgium · Bupivacaïne Glucose Aguettant
- Bulgaria · Бемевакс, Бупивакаин Гриндекс
- Czechia · Bupivacaine Grindeks, Bupivacaine Noridem
- Denmark · Bupivacain Sad, Bupivacaine Aguettant
- Estonia · Bemevax, Bupivacaine Baxter
- Spain · Bupivacaína Aurovitas, Bupivacaína B. Braun
- Finland · Bicain Pond Spinal, Bicain Spinal
- France · Bupivacaine Aguettant, Bupivacaïne Pour Rachianesthesie Aguettant
- United Kingdom (Northern Ireland) · Bufyl 1 Mg/Ml And 2 Microgram/Ml Solution For Infusion, Bupivacaine
- Hungary · Bucain, Bucain Actavis
- Ireland · Bupivacaine Baxter, Bupivacaine Heavy Aguettant
- Iceland · Bupivacaine Spinal Tung Aguettant, Exparel Liposomal
- Italy · Bupicain, Bupisen
- Liechtenstein · Exparel Liposomal
- Lithuania · Bupivacaine Grindeks, Mofecet
- Luxembourg · Bupivacaïne Glucose Aguettant
- Latvia · Bupivacaine Grindeks, Bupivacaine Spinal Grindeks
- Malta · Bupivacaine Baxter, Bupivacaine Baxter Holding
- Netherlands · Bupivacaïne Accord, Bupivacaïne Glucose Aguettant
- Norway · Bupivacaine Baxter, Bupivacaine Noridem
- Poland · Bupivacaine Grindeks, Bupivacaine Spinal Grindeks
- Portugal · Bupinostrum Hiperbárica, Bupinostrum Isobárica
- Romania · Bemevax, Bupivacaină Grindeks
- Sweden · Bupivacaine Baxter, Bupivacaine Spinal Tung
- Slovenia · Bupivakain Accord, Bupivakain Grindeks
- Slovakia · Bupivacaine Grindeks, Bupivakaín Accord
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/c2603187-11d5-4781-b142-5159a3a3a03b GET /v1/drugs/c2603187-11d5-4781-b142-5159a3a3a03b?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": "Intrathecal Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Bupivacaine Hydrochloride Ph.Eur.",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about bupivacaine hydrochloride ph.eur..
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.