Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Litak   
Auth. number : EU/1/04/275
Active substance : Cladribine
Orphan market exclusivity for "Treatment of indolent non-Hodgkin's lymphoma" (based on designation EU/3/01/055) started on 19/04/2004
   10 years of market exclusivity
   This orphan market exclusivity has ended on 19/04/2014
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: L01BB04 - cladribine
(See WHO ATC Index)
Indication: treatment of hairy cell leukaemia
Marketing Authorisation Holder: Lipomed GmbH
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland
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
19/04/2004 Centralised - Authorisation EMEA/H/C/504 (2004)1478 of 14/04/2004
15/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/504/IA/1
11/11/2004 Centralised - Notification EMEA/H/C/504/N/2
01/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/504/IA/3
02/08/2005 Centralised - Variation EMEA/H/C/504/IA/4
Updated with Decision(2006)789 of 08/03/2006
10/03/2006 Centralised - Variation (2006)789 of 08/03/2006
09/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/504/IA/5
09/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/504/IA/6
12/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/504/IA/7
01/04/2009 Centralised - Renewal EMEA/H/C/504/R/8 (2009)2471 of 27/03/2009
03/06/2009 Centralised - Variation EMEA/H/C/504/IA/9
Updated with Decision(2009)10590 of 18/12/2009
22/12/2009 Centralised - Variation (2009)10590 of 18/12/2009
02/08/2013 Centralised - Notification EMEA/H/C/504/N/10
Updated with Decision(2018)1534 of 07/03/2018
19/04/2014 Centralised - (orphan status)
09/03/2018 Centralised - 2-Monthly update EMEA/H/C/504/IB/13 (2018)1534 of 07/03/2018