France· FR:60295427
BENDAMUSTINE MYLAN 2,5 mg/ml, poudre pour solution à diluer pour perfusion
A medicinal product containing bendamustine (chlorhydrate de) monohydraté, registered in France by MYLAN SAS.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- BENDAMUSTINE (CHLORHYDRATE DE) MONOHYDRATÉ
- Manufacturer
- MYLAN SAS
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip1334009550267305 flacon(s) en verre brun de 100 mg de poudre
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bendamustine (chlorhydrate de) monohydraté in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsBendamustine Accord 2,5 mg/ml poeder voor concentraat voor oplossing voor infusieAccord Healthcare B.V.
- United StatesBELRAPZOEagle Pharmaceuticals, Inc
- United KingdomBendamustine 100mg powder for concentrate for solution for infusion vialsSeacross Pharmaceuticals Ltd
- BelgiumBendamustine Accord 2.5 mg/mlAccord Healthcare
- SwitzerlandBendamustin Accord
- CzechiaBENDAMUSTINE ACCORDACCORD HEALTHCARE POLSKA Sp. z o.o., Varšava
- SpainBENDAMUSTINA ACCORD 2,5 MG/ML POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFGAccord Healthcare S.L.U.
- FinlandAlkybendUAB Norameda
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Bendamustin Accord, Bendamustin Hikma
- Belgium · Bendamustine Accord, Bendamustine Eugia
- Bulgaria · Бендамустин Акорд, Бендамустин Актавис
- Cyprus · Bendamustin Ledpharm, Bendamustine Accord
- Czechia · Bendamustine Accord, Bendamustine Kabi
- Germany · Benda Nc, Bendamustin Accord
- Denmark · Bendamedac, Bendamustin Actavis
- Estonia · Bendamustine Accord, Bendamustine Kabi
- Spain · Bendamustina Accord, Bendamustina Aurovitas
- Finland · Bendamustine Accord, Bendamustine Avansor
- United Kingdom (Northern Ireland) · Bendamustine Hikma Farmacêutica (Portugal), Bendamustine Hydrochloride
- Greece · Bendamustine Accord, Bendamustine Actavis
- Croatia · Bendamustin Kabi, Bendamustin Pharmas
- Hungary · Bendamustin Teva, Bendamustine Accord
- Ireland · Bendamustine Accord Healthcare, Bendamustine Accord Healthcare Ireland
- Iceland · Bendamustine Accord, Bendamustine Medac
- Italy · Bendamustina Accord, Bendamustina Aurobindo
- Lithuania · Bendamustine Accord, Bendamustine Kabi
- Luxembourg · Bendamustine Fresenius Kabi, Levact
- Latvia · Bendamustine Accord, Bendamustine Kabi
- Malta · Bendamustine Accord Healthcare, Bendamustine Hydrochloride
- Netherlands · Bendamustine Accord, Bendamustine Baxter
- Norway · Bendamustine Accord, Bendamustine Fresenius Kabi
- Poland · Bendamustine Accord, Bendamustine Eugia
- Portugal · Bendamustina Accord, Bendamustina Generis
- Romania · Bendamustina Accord, Bendamustină Accord
- Sweden · Bendamustin Actavis, Bendamustine Accord
- Slovenia · Bendamustin Accord, Bendamustin Kabi
- Slovakia · Bendamustine Accord, Bendamustine Glenmark
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 Base de données publique des médicaments — BDPM (France). 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/076961bd-74c1-4c92-a937-d5ce9c32be80 GET /v1/drugs/076961bd-74c1-4c92-a937-d5ce9c32be80?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.
{
"cis": "60295427",
"date_amm": "2017-05-03",
"type_amm": "Procédure de reconnaissance mutuelle",
"numero_ue": null,
"substance": "BENDAMUSTINE (CHLORHYDRATE DE) MONOHYDRATÉ",
"statut_amm": "Autorisation abrogée",
"statut_bdm": "Warning disponibilité",
"forme_pharmaceutique": "poudre pour solution à diluer pour perfusion",
"voies_administration": "intraveineuse",
"etat_commercialisation": "Non commercialisée",
"surveillance_renforcee": "Non"
}See everything about bendamustine (chlorhydrate de) monohydraté.
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.