Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kepivance   
Auth. number : EU/1/05/314
INN : Palifermin
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AF - Detoxifying agents for antineoplastic treatment
Chemical substance: V03AF08 - Palifermin
(See WHO ATC Index)
Indication: Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous haematopoietic stem cell support.
Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ)
SE-112 76, Stockholm, 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
27/10/2005 Centralised - Authorisation EMEA/H/C/609 (2005)4262 of 25/10/2005
13/02/2006 Other procedure EMEA/H/C/609 (2006)453 of 09/02/2006
28/03/2006 Centralised - Variation EMEA/H/C/609/II/1
10/05/2006 Centralised - Variation EMEA/H/C/609/IB/2
Updated with Decision(2006)5920 of 28/11/2006
27/09/2006 Centralised - Variation EMEA/H/C/609/II/3
01/12/2006 Centralised - Variation (2006)5920 of 28/11/2006
02/03/2007 Centralised - Variation EMEA/H/C/609/II/4 (2007)741 of 28/02/2007
12/04/2007 Centralised - Variation EMEA/H/C/609/IB/6
Updated with Decision(2007)5556 of 13/11/2007
03/05/2007 Centralised - Variation EMEA/H/C/609/II/5
15/11/2007 Centralised - Variation (2007)5556 of 13/11/2007
28/02/2008 Centralised - Variation EMEA/H/C/609/II/7 (2008)821 of 26/02/2008
15/05/2008 Centralised - Variation EMEA/H/C/609/IB/10
Updated with Decision(2008)3555 of 07/07/2008
30/06/2008 Centralised - Variation EMEA/H/C/609/II/8
09/07/2008 Centralised - Variation EMEA/H/C/609/II/9 (2008)3555 of 07/07/2008
24/11/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/609/T/11 (2008)7424 of 20/11/2008
10/02/2009 Centralised - Variation EMEA/H/C/609/IA/13
21/04/2009 Centralised - Variation EMEA/H/C/609/IA/14
08/06/2009 Centralised - Variation EMEA/H/C/609/IA/16
Updated with Decision(2009)6242 of 31/07/2009
02/07/2009 Centralised - Variation EMEA/H/C/609/II/12 (2009)5328 of 29/06/2009
04/08/2009 Centralised - Variation EMEA/H/C/609/II/15 (2009)6242 of 31/07/2009
06/10/2009 Centralised - Variation EMEA/H/C/609/IA/17
09/10/2009 Centralised - Variation EMEA/H/C/609/IA/20
09/10/2009 Centralised - Variation EMEA/H/C/609/IA/19
09/10/2009 Centralised - Variation EMEA/H/C/609/IA/21
09/10/2009 Centralised - Variation EMEA/H/C/609/IA/18
09/11/2009 Centralised - Variation EMEA/H/C/609/IA/22
16/12/2009 Centralised - Variation EMEA/H/C/609/IB/23
Updated with Decision(2010)1812 of 15/03/2010
11/03/2010 Centralised - Variation EMEA/H/C/609/IB/25
17/03/2010 Centralised - Variation (2010)1812 of 15/03/2010
26/04/2010 Centralised - Variation EMEA/H/C/609/IA/26
Updated with Decision(2010)4991 of 13/07/2010
03/05/2010 Centralised - Variation EMEA/H/C/609/II/24 (2010)2934 of 29/04/2010
15/07/2010 Centralised - Variation (2010)4991 of 13/07/2010
27/09/2010 Centralised - Renewal EMEA/H/C/609/R/27 (2010)6714 of 23/09/2010
14/12/2010 Centralised - Variation EMEA/H/C/609/IA/28/G
Updated with Decision(2011)3084 of 02/05/2011
16/02/2011 Centralised - Variation EMEA/H/C/609/IA/30/G
Updated with Decision(2011)3084 of 02/05/2011
04/05/2011 Centralised - Variation EMEA/H/C/609/II/29 (2011)3084 of 02/05/2011
09/07/2012 Centralised - Variation EMEA/H/C/609/IB/35
Updated with Decision(2012)7718 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7718 of 25/10/2012
30/05/2013 Centralised - Variation EMEA/H/C/609/II/39/G
Updated with Decision(2014)3817 of 03/06/2014
05/06/2014 Centralised - Variation (2014)3817 of 03/06/2014