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Netherlands· NL-44aabc5805ed

Darzalex 1 800 mg oplossing voor injectie

A daratumumab product containing daratumumab, registered in Netherlands by Janssen-Cilag International NV. The same ATC class is registered in 13 of our 19 countries.

ATC L01FC01

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedDarzalex 1 800 mg oplossing voor inje…ATCL01FC01REGISTER NO.NL-44aabc5805edPACKS LISTED1CHECKEDSeptember 29, 2026

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: Netherlands, from CBG-MEB (Netherlands)
  • 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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
DARATUMUMAB
Manufacturer
Janssen-Cilag International NV
Country
Netherlands (NL)
ATC code
L01FC01
ATC class
Daratumumab
Defined daily dose
64.3 mg, P
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/16/1101

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All daratumumab products

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 CBG-MEB (Netherlands). 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/dd2694b8-1f6e-4473-a8fc-e3460d3c6bbf
GET /v1/drugs/dd2694b8-1f6e-4473-a8fc-e3460d3c6bbf?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": "Oplossing voor injectie",
  "route": "Subcutaan gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Daratumumab",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp125413",
  "excipients": [
    "HISTIDINE, (L-)",
    "HISTIDINEMONOHYDROCHLORIDE 1-WATER (L-)",
    "HYALURONIDASE PH20, HUMAAN, RECOMBINANT",
    "METHIONINE, (L-)",
    "POLYSORBAAT 20 (E 432)",
    "SORBITOL (E 420)",
    "WATER VOOR INJECTIE"
  ],
  "substances": [
    "DARATUMUMAB"
  ],
  "leaflet_url": null,
  "authorised_at": "2020/06/03",
  "procedure_number": "EMEA/H/C/004077",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/16/1101",
  "additional_monitoring": "N"
}

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.