Germany· DE-A57-ec6de4b7c866965d
Fludarabin Hexal
A medicinal product containing fludarabine phosphate ph. eur., registered in Germany by Hexal Ag.
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
- Fludarabine Phosphate Ph. Eur.
- Manufacturer
- Hexal Ag
- 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
Fludarabine phosphate ph. eur. in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomFludara 10mg tabletsSanofi
- United StatesFludarabineFresenius Kabi USA, LLC
- CzechiaFLUDARASanofi B.V., Amsterdam
- BelgiumFludara 50 mgSanofi
- SpainBENEFLUR 10 mg COMPRIMIDOS RECUBIERTOSSanofi B.V.
- NetherlandsFludara 10 mg, filmomhulde tablettenSanofi B.V.
- SwedenFludara 10 mg Filmdragerad tablettSanofi B.V.
- FranceFLUDARA 10 mg, comprimé pelliculéSANOFI (PAYS-BAS)
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Fludarabin Accord, Neoflubin
- Belgium · Fludarabine Accord Healthcare, Fludarabine Teva
- Bulgaria · Флударабин Акорд, Флударабин Актавис
- Cyprus · Fludara, Fludarabine Accord
- Czechia · Fludara, Fludarabine Accord
- Denmark · Fludarabinphosphat Ebewe
- Estonia · Fludarabine Accord, Fludarabine Ebewe
- Spain · Beneflur, Fludarabina Accord
- Finland · Fludara, Fludarabin Ebewe
- France · Fludara, Fludarabine Accord
- United Kingdom (Northern Ireland) · Fludara, Fludara Oral
- Greece · Fludara
- Croatia · Fludarabin Accord, Fludarabine Pliva
- Hungary · Fludara, Fludarabin Accord
- Ireland · Fludara, Fludarabine Phosphate Accord Healthcare
- Iceland · Fludarabin Teva
- Italy · Fludara, Fludarabina Accord
- Lithuania · Fludara, Fludarabine Accord
- Luxembourg · Fludarabine Teva
- Latvia · Fludara
- Malta · Fludara
- Netherlands · Fludara, Fludarabine Sandoz
- Norway · Fludarabin Ebewe, Fludarabin Teva
- Poland · Fludara, Fludarabine Accord
- Portugal · Fludarabina Accord, Fludarabina Aurovitas
- Romania · Fludarabină Accord, Fludarabina Teva
- Sweden · Fludarabin Ebewe, Fludarabin Teva
- Slovenia · Fludarabin Accord, Fludarabin Teva
- Slovakia · Fludara, Fludarabin Sandoz
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/a2297cd9-31ad-4cd6-a8cd-f6d6a56a1fcd GET /v1/drugs/a2297cd9-31ad-4cd6-a8cd-f6d6a56a1fcd?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": "Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Fludarabine Phosphate Ph. Eur.",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about fludarabine phosphate 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.