Azacitidine Accord

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azacitidine

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

Overview

Azacitidine Accord is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow’s ability to produce healthy blood cells):

  • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine Accord 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 Accord 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 and the bone marrow consists of 20 to 30% abnormal cells;
  • AML, when the bone marrow has more than 30% abnormal cells.

Azacitidine Accord contains the active substance azacitidine.

Azacitidine Accord is a ‘generic medicine’. This means that Azacitidine Accord 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 21/02/2020

Authorisation details

Product details
Name
Azacitidine Accord
Agency product number
EMEA/H/C/005147
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
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
13/02/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

Azacitidine Accord - EMEA/H/C/005147 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Azacitidine Accord 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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