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Belgium· BE-AMP-SAM500906-00

Darzalex 20 mg/ml

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

ATC L01FC01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDarzalex 20 mg/mlATCL01FC01REGISTER NO.BE-AMP-SAM500906-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about daratumumabAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose
Search daratumumab products by name

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

FAMHP / AFMPS (Belgium)
Active substance
Daratumumab
Manufacturer
Janssen-Cilag International
Country
Belgium (BE)
ATC code
L01FC01
ATC class
Daratumumab
Defined daily dose
64.3 mg, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    7718232
  • be_apb
    4648945

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
Check daratumumab against other medicinesHow interaction checks work

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 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/e6761463-34e1-489b-ba15-e32db4003c93
GET /v1/drugs/e6761463-34e1-489b-ba15-e32db4003c93?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": "AUTHORIZED",
  "name_en": "Darzalex 20 mg/ml",
  "name_fr": "Darzalex 20 mg/ml",
  "name_nl": "Darzalex 20 mg/ml",
  "amp_code": "SAM500906-00",
  "strengths": [
    "20.0000",
    "1.8600"
  ],
  "pack_count": 2,
  "substances": [
    "Daratumumab",
    "Mannitol",
    "Polysorbate 20",
    "Sodium"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Daratumumab",
  "authorisation_numbers": [
    "EU/1/16/1101/002"
  ]
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console