Belgium· BE-AMP-SAM478951-00
Unituxin 3,5 mg/ml
A dinutuximab beta product containing dinutuximab, registered in Belgium by United Therapeutics Europe. The same ATC class is registered in 2 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Dinutuximab beta is registered in 2 of 19 countries.
Countries holding a registration under ATC L01XC16 (dinutuximab beta), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 1 of them publish a price we can compare per daily dose
Dinutuximab beta · ATC L01XC16
2 / 19 countries
- Belgiumprice
- Ireland
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Dinutuximab
- Manufacturer
- United Therapeutics Europe
- Country
- Belgium (BE)
- ATC code
- L01XC16
- ATC class
- Dinutuximab beta
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 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
Dinutuximab beta in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandUnituxinUnited Therapeutics Europe Ltd
- United StatesUnituxinUnited Therapeutics Corporation
- SwitzerlandQarziba 20,25 mg/4,5 ml, Konzentrat zur Herstellung einer InfusionslösungMedius AG
- CzechiaQARZIBARecordati Netherlands B.V., Schiphol-Rijk
- SpainQARZIBA 4,5 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSIONRecordati Netherlands B.V.
- FranceQARZIBA 4,5 mg/ml, solution à diluer pour perfusionRECORDATI IRELAND
- United KingdomQarziba 20mg/4.5ml concentrate for solution for infusion vialsRecordati UK Ltd
- IcelandQarzibaRecordati Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Qarziba
- Liechtenstein · Qarziba
- Norway · Qarziba
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 FAMHP / AFMPS (Belgium). 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/9c1b8c10-9e37-428d-93a9-5269b517c49c GET /v1/drugs/9c1b8c10-9e37-428d-93a9-5269b517c49c?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.
{
"form": "Concentrate for solution for infusion",
"source": "afmps",
"status": "REVOKED",
"name_en": "Unituxin 3,5 mg/ml",
"name_fr": "Unituxin 3,5 mg/ml",
"name_nl": "Unituxin 3,5 mg/ml",
"amp_code": "SAM478951-00",
"strengths": [
"3.5000"
],
"pack_count": 1,
"substances": [
"Dinutuximab"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Dinutuximab",
"authorisation_numbers": [
"EU/1/15/1022/001"
]
}See everything about dinutuximab beta.
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.