Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ceplene   
Auth. number : EU/1/08/477
Active substance : Histamine dihydrochloride
Orphan market exclusivity for "Treatment of acute myeloid leukaemia" (based on designation EU/3/05/272) started on 09/10/2008
   10 years of market exclusivity
   This orphan market exclusivity will expire on 09/10/2018
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AX - Other immunostimulating agents
Chemical substance: L03AX14 - Histamine dihydrochloride
(See WHO ATC Index)
Indication: Ceplene maintenance therapy is Indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.
Marketing Authorisation Holder: Meda AB
Box 906, SE-170 09 Solna, Sverige
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
09/10/2008 Centralised - Authorisation EMEA/H/C/796 (2008)5930 of 07/10/2008
24/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/796/IA/1
23/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/796/IA/2
19/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/796/IB/3
03/05/2010 Centralised - Annual reassessment EMEA/H/C/796/S/5 (2010)2928 of 29/04/2010
02/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/796/IB/7
09/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/796/IA/8/G
27/01/2011 Centralised - Variation EMEA/H/C/796/II/6 (2011)465 of 24/01/2011
18/04/2011 Centralised - Annual reassessment EMEA/H/C/796/S/10 (2011)2796 of 14/04/2011
12/12/2011 Referral EMEA/H/C/796/A-20/11 (2011)9327 of 08/12/2011
24/04/2012 Centralised - Annual reassessment EMEA/H/C/796/S/12 (2012)2838 of 20/04/2012
04/06/2012 Referral EMEA/H/C/796/A-20/11 (2012)3713 of 31/05/2012
17/10/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/796/T/13 (2012)7399 of 15/10/2012
28/08/2013 Centralised - Renewal EMEA/H/C/796/R/15 (2013)5602 of 26/08/2013
20/02/2014 Centralised - Variation EMEA/H/C/796/II/17
Updated with Decision(2015)755 of 06/02/2015
20/03/2014 Centralised - Annual reassessment EMEA/H/C/796/S/20
26/03/2014 Centralised - Annual reassessment EMEA/H/C/796/S/14 (2014)2054 of 21/03/2014
10/02/2015 Centralised - Yearly update (2015)755 of 06/02/2015
26/03/2015 Centralised - Annual reassessment EMEA/H/C/796/S/22
22/06/2015 Centralised - Variation EMEA/H/C/796/IB/23/G
01/04/2016 Centralised - Annual reassessment EMEA/H/C/796/S/26