Germany· DE-A57-bdad7fc66cca533a
Mitoxantron Hexal
A medicinal product containing mitoxantrone hydrochloride 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
- Mitoxantrone Hydrochloride 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
Mitoxantrone hydrochloride ph. eur. in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomMitoxantrone 10mg/5ml solution for infusion vialsWockhardt UK Ltd
- FinlandMitoxantron AccordAccord Healthcare B.V.
- BelgiumMitoxantrone Accord 2 mg/mlAccord Healthcare
- United StatesmitoXANTRONEMeitheal Pharmaceuticals Inc.
- SpainMITOXANTRONA ACCORD 2 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFGAccord Healthcare S.L.U.
- FranceMITOXANTRONE ACCORD 2 mg/mL, solution à diluer pour perfusionACCORD HEALTHCARE FRANCE
- NetherlandsMitoxantron Accord 2 mg/ml, concentraat voor oplossing voor infusieAccord Healthcare B.V.
- SwedenMitoxantron Ebewe 2 mg/ml Koncentrat till infusionsvätska, lösningEBEWE Pharma Ges.m.b.H.Nfg.KG
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Ebexantron
- Belgium · Mitoxantrone Sandoz
- Bulgaria · Митоксантрон Ебеве
- Denmark · Mitoxantron "ebewe"
- Estonia · Onkotrone
- Spain · Mitoxantrona Accord, Novantrone
- Finland · Mitoxantron Ebewe
- France · Mitoxantrone Accord
- United Kingdom (Northern Ireland) · Mitoxantrone Accord Healthcare, Onkotrone Injection
- Greece · Mitoxan
- Hungary · Onkotrone
- Italy · Onkotrone
- Lithuania · Onkotrone
- Luxembourg · Mitoxantrone Sandoz
- Latvia · Onkotrone
- Malta · Onkotrone
- Netherlands · Mitoxantron Accord, Mitoxantron Sandoz
- Norway · Mitoxantron Ebewe
- Poland · Mitoxantron Sandoz
- Portugal · Mitoxantrona Pharmis, Mitoxantrone Baxter
- Romania · Onkotrone
- Sweden · Mitoxantron Ebewe
- Slovenia · Onkotrone
- Slovakia · Onkotrone
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/99a79155-5f96-4fe1-be43-5f94ad8d264f GET /v1/drugs/99a79155-5f96-4fe1-be43-5f94ad8d264f?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": "Mitoxantrone Hydrochloride Ph. Eur.",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about mitoxantrone 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.