Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Xaluprine   
Auth. number : EU/1/11/727
Active substance : Mercaptopurine
Orphan market exclusivity for "Treatment of acute lymphoblastic leukaemia" (based on designation EU/3/09/628) started on 13/03/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 13/03/2022
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: L01BB02 - mercaptopurine
(See WHO ATC Index)
Indication: Treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Marketing Authorisation Holder: Nova Laboratories Ireland Limited
3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
13/03/2012 Centralised - Authorisation EMEA/H/C/2022 (2012)1650 of 9/03/2012
31/05/2012 Centralised - Variation EMEA/H/C/2022/IA/1
Updated with Decision(2012)8488 of 15/11/2012
19/11/2012 Centralised - Variation EMEA/H/C/2022/II/2/G (2012)8488 of 15/11/2012
11/03/2013 Centralised - Variation EMEA/H/C/2022/IB/4
Updated with Decision(2014)9825 of 20/12/2013
24/12/2013 PSUSA - Modification EMEA/H/C/2022/PSU/6 (2014)9825 of 20/12/2013
21/11/2014 PSUSA - Modification EMEA/H/C/2022/PSUV/8 (2014)8892 of 19/11/2014
9/06/2016 Centralised - Variation EMEA/H/C/2022/IAIN/13
Updated with Decision(2016)7598 of 18/11/2016
22/11/2016 Centralised - Renewal EMEA/H/C/2022/R/12 (2016)7598 of 18/11/2016
17/07/2017 PSUSA - Modification EMEA/H/C/PSUSA/1988/201609 (2017)5093 of 13/07/2017
23/10/2018 Centralised - Variation EMEA/H/C/2022/IB/16/G
Updated with Decision(2019)846 of 31/01/2019
14/11/2018 Centralised - Notification EMEA/H/C/002022/N/0017
Updated with Decision(2019)846 of 31/01/2019
4/02/2019 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/002022/T/0020 (2019)846 of 31/01/2019