An overview of Mylotarg and why it is authorised in the EU
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.
Mylotarg : EPAR - Summary for the public (PDF/75.51 KB)
First published: 04/05/2018
Last updated: 04/05/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Myeloid, Acute
|Anatomical therapeutic chemical (ATC) code||
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.
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
30/07/2018 Mylotarg - EMEA/H/C/004204 - T/0001
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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).