Mylotarg
·
- Prescription status not stated
- Active substance
- Gemtuzumab ozogamicin
- Made by
- Pfizer Europe MA EEIG
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Pfizer Europe MA EEIG |
|---|---|
| Active substance | Gemtuzumab ozogamicin |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Authorised on | 2018-04-19 |
| Last updated by the regulator | 2025-09-17 |
| EMA product number | EMEA/H/C/004204 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).