Finland· FI-REL-REL48066

Darzalex

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

ATC L01FC01

Checked against Fimea (Finland) on

Informational only — not a medical device.

SOURCE REGISTER · FIFimea (Finland)normalisedDarzalexATCL01FC01REGISTER NO.FI-REL-REL48066PACKS LISTED2CHECKEDSeptember 27, 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: Finland, from Fimea (Finland)
  • 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

Fimea (Finland)
Active substance
Daratumumab
Manufacturer
Janssen-Cilag International NV
Country
Finland (FI)
ATC code
L01FC01
ATC class
Daratumumab
Defined daily dose
64.3 mg, P
Reimbursed
Not published by this register
Source register
Fimea (Finland)
Last checked
September 27, 2026

Packs & prices · 2

2 priced
  • fi_myyntilupa
    134235
    5 ml
    EUR 640.39
  • fi_myyntilupa
    493370
    20 ml
    EUR 2390.72

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 Fimea (Finland). 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/431fe608-1f9c-4e00-b844-882111283a2e
GET /v1/drugs/431fe608-1f9c-4e00-b844-882111283a2e?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.

{
  "ddd": "64.3",
  "form": "infuusiokonsentraatti, liuosta varten",
  "route": "Laskimoon",
  "ddd_unit": "mg",
  "strength": "20 mg/ml",
  "atc_label": "daratumumabi",
  "ma_number": null,
  "auth_status": "Myyntilupa myönnetty",
  "eu_ma_number": "EU/1/16/1101/001-003",
  "fimea_rel_id": "REL48066",
  "authorised_at": "2016-05-20"
}

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.