Azacitidine Celgene

RSS
Withdrawn

This medicine's authorisation has been withdrawn

azacitidine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.

Azacitidine Celgene : EPAR - Medicine overview

Reference Number: EMA/384352/2019

English (EN) (664.65 KB - PDF)

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български (BG) (759.74 KB - PDF)

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čeština (CS) (742.02 KB - PDF)

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dansk (DA) (613.46 KB - PDF)

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Deutsch (DE) (664.92 KB - PDF)

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eesti keel (ET) (662.32 KB - PDF)

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ελληνικά (EL) (772.36 KB - PDF)

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français (FR) (664.57 KB - PDF)

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hrvatski (HR) (687.97 KB - PDF)

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italiano (IT) (661.86 KB - PDF)

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latviešu valoda (LV) (747.91 KB - PDF)

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lietuvių kalba (LT) (689.92 KB - PDF)

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magyar (HU) (735.9 KB - PDF)

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Malti (MT) (748.95 KB - PDF)

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Nederlands (NL) (662.38 KB - PDF)

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polski (PL) (736.99 KB - PDF)

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português (PT) (663.89 KB - PDF)

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română (RO) (695.1 KB - PDF)

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slovenčina (SK) (740.25 KB - PDF)

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slovenščina (SL) (733.35 KB - PDF)

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Suomi (FI) (661.01 KB - PDF)

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svenska (SV) (663.03 KB - PDF)

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Azacitidine Celgene : EPAR - Risk-management-plan summary

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Product information

Azacitidine Celgene : EPAR - Product information

English (EN) (1.2 MB - PDF)

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български (BG) (2.17 MB - PDF)

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español (ES) (1.2 MB - PDF)

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čeština (CS) (1.85 MB - PDF)

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dansk (DA) (1.19 MB - PDF)

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Deutsch (DE) (1.26 MB - PDF)

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eesti keel (ET) (1.23 MB - PDF)

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ελληνικά (EL) (1.91 MB - PDF)

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français (FR) (1.27 MB - PDF)

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hrvatski (HR) (1.27 MB - PDF)

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íslenska (IS) (1.23 MB - PDF)

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italiano (IT) (1.22 MB - PDF)

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latviešu valoda (LV) (1.96 MB - PDF)

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lietuvių kalba (LT) (1.32 MB - PDF)

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magyar (HU) (1.83 MB - PDF)

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Malti (MT) (1.98 MB - PDF)

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Nederlands (NL) (1.23 MB - PDF)

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norsk (NO) (1005.19 KB - PDF)

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polski (PL) (1.9 MB - PDF)

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português (PT) (435.74 KB - PDF)

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română (RO) (1.34 MB - PDF)

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slovenčina (SK) (1.91 MB - PDF)

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slovenščina (SL) (1.83 MB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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Suomi (FI) (1.2 MB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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svenska (SV) (1.21 MB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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Latest procedure affecting product information: WITHDRAWAL
21/05/2021
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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).

Azacitidine Celgene : EPAR - All authorised presentations

English (EN) (594.29 KB - PDF)

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български (BG) (666.54 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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español (ES) (636.01 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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čeština (CS) (666.5 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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dansk (DA) (658.23 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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Deutsch (DE) (644.69 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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eesti keel (ET) (633.49 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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ελληνικά (EL) (663.78 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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français (FR) (637.95 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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hrvatski (HR) (634.97 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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íslenska (IS) (638.38 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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italiano (IT) (635.86 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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latviešu valoda (LV) (657.93 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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lietuvių kalba (LT) (637.01 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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magyar (HU) (653.48 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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Malti (MT) (657.82 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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Nederlands (NL) (635.42 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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norsk (NO) (637.91 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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polski (PL) (656.98 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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português (PT) (637.04 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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română (RO) (639.73 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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slovenčina (SK) (656.6 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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slovenščina (SL) (652.52 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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Suomi (FI) (633.48 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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svenska (SV) (638.06 KB - PDF)

First published: 14/08/2019Last updated: 04/08/2021
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Product details

Name of medicine
Azacitidine Celgene
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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/005300
Marketing authorisation holder
Celgene Europe BV

Winthontlaan 6 N
3526KV Utrecht
The Netherlands

Opinion adopted
27/06/2019
Marketing authorisation issued
02/08/2019
Revision
2

Assessment history

Azacitidine Celgene : EPAR - Procedural steps taken and scientific information after the authorisation

English (EN) (713.23 KB - PDF)

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Azacitidine Celgene : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/445484/2019

English (EN) (816.42 KB - PDF)

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CHMP summary of positive opinion for Azacitidine Celgene

AdoptedReference Number: EMA/CHMP/332005/2019

English (EN) (631.69 KB - PDF)

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More information on Azacitidine Celgene

Public statement on Azacitidine Celgene : Withdrawal of the marketing authorisation in the European Union

AdoptedReference Number: EMA/305416/2021

English (EN) (129.53 KB - PDF)

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