Poland· PL-100370449
Darzalex
A daratumumab product containing daratumumabum, registered in Poland by Janssen-Cilag International N.V.. The same ATC class is registered in 13 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Daratumumabum
- Manufacturer
- Janssen-Cilag International N.V.
- Country
- Poland (PL)
- ATC code
- L01FC01
- ATC class
- Daratumumab
- Defined daily dose
- 64.3 mg, P
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 3
- gtin05909991275228
- gtin04150115644678
- gtin05909991275235
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.
- United StatesDARZALEXJanssen Biotech, Inc.
- CzechiaDARZALEXJanssen-Cilag International N.V., Beerse
- FinlandDarzalexOrifarm Oy
- BelgiumDarzalex 20 mg/mlJanssen-Cilag International
- NorwayDarzalexJanssen-Cilag International N.V.
- IcelandDarzalexJanssen-Cilag International NV*
- SwedenDARZALEX 20 mg/ml Koncentrat till infusionsvätska, lösningJanssen-Cilag International NV
- IrelandDARZALEX 20 mg/mL concentrate for solution for infusionJanssen-Cilag International NV
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 URPL (Poland). 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/8211178d-f947-4536-80ea-6246717e14b2 GET /v1/drugs/8211178d-f947-4536-80ea-6246717e14b2?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": "Koncentrat do sporządzania roztworu do infuzji",
"source": "urpl",
"strength": "20 mg/ml",
"packaging": "05909991275228 ¦ Rpz ¦ EU/1/16/1101/001 ¦ 115673\n1 fiol. 5 ml\n¦ UR/Z/4b/144/26 - 04150115644678\n05909991275235 ¦ Rpz ¦ EU/1/16/1101/002 ¦ 115674\n1 fiol. 20 ml\nRpz ¦ EU/1/16/1101/003 ¦ 134525\n5 fiol. 20 ml\nRpz ¦ EU/1/16/1101/003 ¦ 134526\n6 fiol. 5 ml",
"substance": "Daratumumabum 20 mg/ml",
"common_name": "Daratumumabum",
"pl_product_id": "100370449",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.