Ireland· IE-PA-EU/1/18/1277/001
MYLOTARG 5 mg powder for concentrate for solution for infusion
A gemtuzumab ozogamicin product containing gemtuzumab ozogamicin, registered in Ireland by Pfizer Europe MA EEIG.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Gemtuzumab ozogamicin
- Manufacturer
- Pfizer Europe MA EEIG
- Country
- Ireland (IE)
- ATC code
- L01XC05
- ATC class
- Gemtuzumab ozogamicin
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/18/1277/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
112 interactions on record for gemtuzumab ozogamicin.
Graded by severity as the source publishes them — 33 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
Gemtuzumab ozogamicin · interactions on record
112 records
- 33 severe
- 64 moderate
- 15 minor
Most severe, free to view
- MipomersenC10AX11severe
- LomitapideC10AX12severe
- CladribineL01BB04severe
- PexidartinibL01EX15severe
- 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.
Same medicine, other countries
Gemtuzumab ozogamicin in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumMylotarg 5 mgPfizer Europe MA
- 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
- IcelandMylotargPfizer Europe MA EEIG*
- NorwayMylotargPfizer Europe MA EEIG (1)
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 HPRA (Ireland). 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/c32638f5-42c1-461f-87f4-7ceea5f60a3f GET /v1/drugs/c32638f5-42c1-461f-87f4-7ceea5f60a3f?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": "Powder for concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"L01XC",
"L01XC05"
],
"strength": null,
"pa_number": "EU/1/18/1277/001",
"substances": [
"Gemtuzumab ozogamicin"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/04/2018",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about gemtuzumab ozogamicin.
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.