France· FR:60664059
MYLOTARG 5 mg, poudre pour solution à diluer pour perfusion
A medicinal product containing gemtuzumab ozogamicine, registered in France by PFIZER EUROPE MA EEIG (BELGIQUE).
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
- GEMTUZUMAB OZOGAMICINE
- Manufacturer
- PFIZER EUROPE MA EEIG (BELGIQUE)
- 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
- cip1334009550540161 flacon en verre de 5 mg
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Gemtuzumab ozogamicine in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsMylotarg 5 mg, poeder voor concentraat voor oplossing voor infusiePfizer Europe MA EEIG
- BelgiumMylotarg 5 mgPfizer Europe MA
- CanadaMYLOTARGPFIZER CANADA ULC
- SwitzerlandMylotarg 5 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungPfizer AG
- CzechiaMYLOTARGPfizer Europe MA EEIG, Bruxelles
- SpainMYLOTARG 5 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONPfizer Europe Ma Eeig
- FinlandMYLOTARGPfizer Europe MA EEIG
- United KingdomMylotarg 5mg powder for concentrate for solution for infusion vialsPfizer Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Mylotarg
- Liechtenstein · Mylotarg
- Norway · Mylotarg
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/b5358ecd-1d40-4c28-b1fc-975213519dc2 GET /v1/drugs/b5358ecd-1d40-4c28-b1fc-975213519dc2?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": "60664059",
"date_amm": "2018-04-19",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/18/1277",
"substance": "GEMTUZUMAB OZOGAMICINE",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "poudre pour solution à diluer pour perfusion",
"voies_administration": "intraveineuse",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about gemtuzumab ozogamicine.
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.