Mylotarg

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gemtuzumab ozogamicin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 15/08/2018

Authorisation details

Product details
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
Anatomical therapeutic chemical (ATC) code
L01XC05
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
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/04/2018
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

30/07/2018 Mylotarg - EMEA/H/C/004204 - T/0001

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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