Czechia· CZ-0249566
DARZALEX
A daratumumab product containing daratumumab, registered in Czechia by Janssen-Cilag International N.V., Beerse. The same ATC class is registered in 13 of our 19 countries.
Checked against SÚKL (Czech Republic) on
Informational only — not a medical device.
Where it is registered
Daratumumab is registered in 13 of 19 countries.
Countries holding a registration under ATC L01FC01 (daratumumab), each read from that country’s own register.
- This record: Czechia, from SÚKL (Czech Republic)
- 8 of them publish a price we can compare per daily dose
Daratumumab · ATC L01FC01
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
SÚKL (Czech Republic)- Active substance
- DARATUMUMAB
- Manufacturer
- Janssen-Cilag International N.V., Beerse
- Country
- Czechia (CZ)
- ATC code
- L01FC01
- ATC class
- Daratumumab
- Defined daily dose
- 64.3 mg, P
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 2026
Packs & prices · 1
1 priced- cz_kod_sukl02495661X15MLCZK 124468.15
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
72 interactions on record for daratumumab.
Graded by severity as the source publishes them — 29 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Daratumumab · interactions on record
72 records
- 29 severe
- 43 moderate
Most severe, free to view
- CladribineL01BB04severe
- Talimogene laherparepvecL01XL02severe
- Talimogen laherparepvecL01XX51severe
- LeflunomidL04AA13severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Daratumumab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumDarzalex 1800 mgJanssen-Cilag International
- IcelandDarzalexJanssen-Cilag International NV*
- NorwayDarzalexJanssen-Cilag International N.V.
- SwedenDARZALEX 1800 mg Injektionsvätska, lösningJanssen-Cilag International NV
- SpainDARZALEX 1.800 MG SOLUCION INYECTABLEJanssen-Cilag International N.V
- United StatesDARZALEXJanssen Biotech, Inc.
- FinlandDarzalexParanova Oy
- SwitzerlandDarzalex
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Darzalex
- Liechtenstein · Darzalex
- Norway · Darzalex
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 SÚKL (Czech Republic). 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/589a3a44-6201-462e-b9f5-377d5ae5205f GET /v1/drugs/589a3a44-6201-462e-b9f5-377d5ae5205f?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": "INJ SOL",
"source": "sukl",
"strength": "1800MG",
"pack_size": "1X15ML",
"substance": "DARATUMUMAB",
"cz_kod_sukl": "0249566",
"product_type": "BT",
"substance_codes": "18606",
"registration_state": "R",
"registration_number": "EU/1/16/1101/004"
}See everything about daratumumab.
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.