🇪🇺 AZACITIDINE in European Union

EMA authorised AZACITIDINE on 2 August 2019

Marketing authorisations

EMA — authorised 2 August 2019

  • Application: EMEA/H/C/005300
  • Marketing authorisation holder: Celgene Europe BV
  • Local brand name: Azacitidine Celgene
  • Indication: Azacitidine Celgene 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.
  • Status: withdrawn

Read official source →

EMA — authorised 13 February 2020

  • Application: EMEA/H/C/005147
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Azacitidine Accord
  • 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.
  • Status: approved

Read official source →

EMA — authorised 24 March 2020

  • Application: EMEA/H/C/005075
  • Marketing authorisation holder: betapharm Arzneimittel GmbH
  • Local brand name: Azacitidine betapharm
  • Indication: Azacitidine betapharm 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 % to 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30 % marrow blasts according to the WHO classification.
  • Status: approved

Read official source →

EMA — authorised 27 March 2020

  • Application: EMEA/H/C/004984
  • Marketing authorisation holder: Mylan Pharmaceuticals Limited
  • Local brand name: Azacitidine Mylan
  • 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.
  • Status: approved

Read official source →

EMA — authorised 5 January 2024

  • Application: EMEA/H/C/006154
  • Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
  • Local brand name: Azacitidine Kabi
  • Indication: Azacitidine Kabi 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 Organization (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.
  • Status: approved

On 5 January 2024, the European Medicines Agency (EMA) granted marketing authorisation for Azacitidine Kabi, a treatment for adult patients with specific blood cancers. Azacitidine Kabi is indicated for patients with intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML), and acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation (HSCT). This approval allows Fresenius Kabi Deutschland GmbH to market Azacitidine Kabi in the European Union.

Read official source →

AZACITIDINE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is AZACITIDINE approved in European Union?

Yes. EMA authorised it on 2 August 2019; EMA authorised it on 13 February 2020; EMA authorised it on 24 March 2020.

Who is the marketing authorisation holder for AZACITIDINE in European Union?

Celgene Europe BV holds the EU marketing authorisation.