Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Atriance   
Auth. number : EU/1/07/403
Active substance : nelarabine
Orphan market exclusivity for "Treatment of acute lymphoblastic leukaemia" (based on designation EU/3/05/293) started on 24/08/2007
   10 years of market exclusivity
   This orphan market exclusivity will expire on 24/08/2017
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BB - Purine analogues
Chemical substance: L01BB07 - Nelarabine
(See WHO ATC Index)
Indication: Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, 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
24/08/2007 Centralised - Authorisation EMEA/H/C/752 (2007)4037 of 22/08/2007
25/08/2008 Centralised - Variation EMEA/H/C/752/IB/2
Updated with Decision(2008)7392 of 19/11/2008
21/11/2008 Centralised - Annual reassessment EMEA/H/C/752/S/1 (2008)7392 of 19/11/2008
20/03/2009 Centralised - Variation EMEA/H/C/752/II/3 (2009)2097 of 18/03/2009
28/09/2009 Centralised - Annual reassessment EMEA/H/C/752/S/4
15/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/752/IB/5
22/01/2010 Centralised - Variation EMEA/H/C/752/II/6 (2010)408 of 20/01/2010
03/12/2010 Centralised - Annual reassessment EMEA/H/C/752/S/7 (2010)8655 of 29/11/2010
19/01/2011 Centralised - Variation EMEA/H/C/752/IG/34/G
Updated with Decision(2011)5388 of 20/07/2011
25/07/2011 Centralised - Variation (2011)5388 of 20/07/2011
01/12/2011 Centralised - Annual reassessment EMEA/H/C/752/S/10 (2011)8854 of 24/11/2011
26/03/2012 Centralised - Variation EMEA/H/C/752/II/12 (2012)2041 of 21/03/2012
21/06/2012 Centralised - Renewal EMEA/H/C/752/R/13 (2012)4269 of 18/06/2012
21/09/2012 Centralised - Annual reassessment EMEA/H/C/752/S/16
18/04/2013 Centralised - Variation EMEA/H/C/752/IG/279
Updated with Decision(2013)9827 of 20/12/2013
01/07/2013 Centralised - Variation EMEA/H/C/752/IAin/20
Updated with Decision(2013)9827 of 20/12/2013
17/09/2013 Centralised - Notification EMEA/H/C/752/N/19
Updated with Decision(2013)9827 of 20/12/2013
02/01/2014 Centralised - Annual reassessment EMEA/H/C/752/S/21 (2013)9827 of 20/12/2013
10/09/2014 Centralised - Variation EMEA/H/C/752/IB/23
Updated with Decision(2015)2917 of 24/04/2015
23/10/2014 Centralised - Annual reassessment EMEA/H/C/752/S/25
28/04/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/752/T/28 (2015)2917 of 24/04/2015
21/05/2015 Centralised - Variation EMEA/H/C/752/II/27
Updated with Decision(2016)168 of 12/01/2016
13/07/2015 Centralised - Variation EMEA/H/C/752/IA/29/G
Updated with Decision(2016)168 of 12/01/2016
14/01/2016 Centralised - Annual reassessment EMEA/H/C/752/S/31 (2016)168 of 12/01/2016
26/07/2016 Centralised - Notification EMEA/H/C/752/N/33
Updated with Decision(2017)4306 of 16/06/2017
10/11/2016 Centralised - Annual reassessment EMEA/H/C/752/S/34
20/06/2017 Centralised - Renewal EMEA/H/C/752/R/37 (2017)4306 of 16/06/2017