Azacitidine Mylan

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azacitidine

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

Overview

Azacitidine Mylan is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient’s bone marrow is replaced to form new bone marrow that produces healthy cells):

  • myelodysplastic syndromes, a group of conditions where the bone marrow produces abnormal blood cells and not enough healthy ones. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine Mylan is used in patients with an intermediate to high risk of progressing to AML or death;
  • chronic myelomonocytic leukaemia (a cancer affecting white blood cells called monocytes). Azacitidine Mylan is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
  • AML that has developed from a myelodysplastic syndrome, where the bone marrow consists of 20 to 30% abnormal cells;
  • AML, where the bone marrow has more than 30% abnormal cells.

Azacitidine Mylan contains the active substance azacitidine.

Azacitidine Mylan is a ‘generic medicine’. This means that Azacitidine Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Vidaza. For more information on generic medicines, see the question-and-answer document here.

This EPAR was last updated on 06/04/2020

Authorisation details

Product details
Name
Azacitidine Mylan
Agency product number
EMEA/H/C/004984
Active substance
azacitidine
International non-proprietary name (INN) or common name
azacitidine
Therapeutic area (MeSH)
  • Myelodysplastic Syndromes
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code
L01BC07
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
27/03/2020
Contact address

Unit 35/36
Grange Parade
Baldoye
Industrial Estate
Dublin 13
Ireland

Product information

Azacitidine Mylan - EMEA/H/C/004984 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:
-         intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
-         chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder,
-         acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification,
-         AML with > 30% marrow blasts according to the WHO classification.

Assessment history

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