France· FR:60047225
DARZALEX 1800 mg, solution injectable
A medicinal product containing daratumumab, registered in France by JANSSEN CILAG INTERNATIONAL NV.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- DARATUMUMAB
- Manufacturer
- JANSSEN CILAG INTERNATIONAL NV
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip1334009302122021 flacon(s) en verre de 15 ml
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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.
- IrelandDARZALEX 1800 mg solution for injectionJanssen-Cilag International NV
- SpainDARZALEX 1.800 MG SOLUCION INYECTABLEJanssen-Cilag International N.V
- United StatesDARZALEXJanssen Biotech, Inc.
- FinlandDarzalexOrifarm Oy
- BelgiumDarzalex 1800 mgJanssen-Cilag International
- CzechiaDARZALEXJanssen-Cilag International N.V., Beerse
- SwitzerlandDarzalex
- United KingdomDarzalex 100mg/5ml concentrate for solution for infusion vialsJanssen-Cilag Ltd
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 Base de données publique des médicaments — BDPM (France). 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/d5da97f9-aa31-4b63-8584-282284db7700 GET /v1/drugs/d5da97f9-aa31-4b63-8584-282284db7700?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.
{
"cis": "60047225",
"date_amm": "2020-06-03",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/16/1101",
"substance": "DARATUMUMAB",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "solution injectable",
"voies_administration": "sous-cutanée",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}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.