gemtuzumab ozogamicin

This medicine is authorised for use in the European Union.


Mylotarg is a medicine used to treat a blood cancer called acute myeloid leukaemia (AML) in patients aged 15 years and above who are newly diagnosed and have not tried other treatments.

It is used in combination with daunorubicin and cytarabine (other cancer medicines).

Mylotarg is used in patients with a protein called CD33 on their cancer cells (which is the case in most patients with AML). It is not used for a type of AML called acute promyelocytic leukaemia (APL).

AML is rare, and Mylotarg was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 October 2000.

Mylotarg contains the active substance gemtuzumab ozogamicin.

This EPAR was last updated on 14/12/2022

Authorisation details

Product details
Agency product number
Active substance
gemtuzumab ozogamicin
International non-proprietary name (INN) or common name
gemtuzumab ozogamicin
Therapeutic area (MeSH)
Leukemia, Myeloid, Acute
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Boulevard de la Plaine 17
1050 Bruxelles

Product information

15/11/2022 Mylotarg - EMEA/H/C/004204 - R/0025

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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).

Assessment history

Related content

How useful was this page?

Add your rating
3 ratings
1 rating