Mylotarg
gemtuzumab ozogamicin
Table of contents
Overview
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.
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List item
Mylotarg : EPAR - Summary for the public (PDF/75.51 KB)
First published: 04/05/2018
Last updated: 04/05/2018
EMA/246931/2018 -
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List item
Mylotarg : EPAR - Risk-management-plan summary (PDF/1.76 MB)
First published: 21/07/2022
Authorisation details
Product details | |
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Name |
Mylotarg
|
Agency product number |
EMEA/H/C/004204
|
Active substance |
gemtuzumab ozogamicin
|
International non-proprietary name (INN) or common name |
gemtuzumab ozogamicin
|
Therapeutic area (MeSH) |
Leukemia, Myeloid, Acute
|
Additional 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
19/04/2018
|
Contact address |
Boulevard de la Plaine 17 |
Product information
15/11/2022 Mylotarg - EMEA/H/C/004204 - R/0025
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).