Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vidaza   
Auth. number : EU/1/08/488
Active substance : Azacitidine
Orphan market exclusivity for "Treatment of myelodysplastic syndromes" (based on designation EU/3/01/084) started on 22/12/2008
   10 years of market exclusivity
   This orphan market exclusivity will expire on 22/12/2018
Orphan market exclusivity for "Treatment of acute myeloid leukaemia" (based on designation EU/3/07/509) started on 22/12/2008
   10 years of market exclusivity
   This orphan market exclusivity will expire on 22/12/2018
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BC - Pyrimidine analogues
Chemical substance: L01BC07 - Azacitidine
(See WHO ATC Index)
Indication: Vidaza 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.
Marketing Authorisation Holder: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/12/2008 Centralised - Authorisation EMEA/H/C/978 (2008)8812 of 17/12/2008
13/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/978/IA/2
22/10/2009 Centralised - Variation EMEA/H/C/978/II/1 (2009)8297 of 20/10/2009
01/07/2010 Centralised - Variation EMEA/H/C/978/IB/3
Updated with Decision(2010)7214 of 14/10/2010
14/07/2010 Centralised - Variation EMEA/H/C/978/IA/4/G
Updated with Decision(2010)7214 of 14/10/2010
18/10/2010 Centralised - Variation (2010)7214 of 14/10/2010
15/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/978/IB/6/G
06/05/2011 Centralised - Variation EMEA/H/C/978/IB/8/G
Updated with Decision(2011)5948 of 10/08/2011
10/06/2011 Centralised - Variation EMEA/H/C/978/IA/10/G
Updated with Decision(2011)5948 of 10/08/2011
16/06/2011 Centralised - Variation EMEA/H/C/978/II/5, 7 (2011)4288 of 14/06/2011
25/07/2011 Centralised - Variation EMEA/H/C/978/IB/13
Updated with Decision(2011)10113 of 22/12/2011
12/08/2011 Centralised - Variation EMEA/H/C/978/II/9 (2011)5948 of 10/08/2011
25/11/2011 Referral EMEA/H/C/978/A-20/17 (2011)8816 of 24/11/2011
28/12/2011 Centralised - Variation EMEA/H/C/978/II/11 (2011)10113 of 22/12/2011
24/04/2012 Centralised - Variation EMEA/H/C/978/II/18 (2012)2832 of 20/04/2012
01/06/2012 Referral EMEA/H/C/978/A-20/17 (2012)3642 of 25/05/2012
15/06/2012 Centralised - Variation EMEA/H/C/978/IA/20/G
Updated with Decision(2012)7157 of 08/10/2012
10/10/2012 Centralised - Variation (2012)7157 of 08/10/2012
15/03/2013 PSUSA - Modification EMEA/H/C/978/PSU/17 (2013)1653 of 13/03/2013
15/11/2013 Centralised - Renewal EMEA/H/C/978/R/24 (2013)8082 of 13/11/2013
29/10/2014 Centralised - 2-Monthly update EMEA/H/C/978/II/28 (2014)8182 of 27/10/2014
19/02/2015 PSUSA - Modification EMEA/H/C/978/PSUV/29 (2015)1030 of 17/02/2015
30/10/2015 Centralised - Variation EMEA/H/C/978/II/30 (2015)7596 of 28/10/2015
01/04/2016 PSUSA - Modification EMEA/H/C/978/PSUSA/274/201505 (2016)1987 of 30/03/2016