Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Savene   
Auth. number : EU/1/06/350
Active substance : Dexrazoxane
Orphan market exclusivity for "Treatment of anthracycline extravasations" (based on designation EU/3/01/059) started on 02/08/2006
   10 years of market exclusivity
   This orphan market exclusivity will expire on 02/08/2016
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: V03AF02 - Dexrazoxane
(See WHO ATC Index)
Indication: Savene is indicated for the treatment of anthracycline extravasation
Marketing Authorisation Holder: Clinigen Healthcare Limited
Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, 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
02/08/2006 Centralised - Authorisation EMEA/H/C/682 (2006)3543 of 28/07/2006
15/08/2006 Centralised - Variation EMEA/H/C/682/IA/1
Updated with Decision(2007)1199 of 09/03/2007
13/03/2007 Centralised - Variation (2007)1199 of 09/03/2007
10/04/2007 Centralised - Notification EMEA/H/C/682/N/2
Updated with Decision(2010)4813 of 06/07/2010
30/08/2007 Centralised - Notification EMEA/H/C/682/N/3
Updated with Decision(2010)4813 of 06/07/2010
13/02/2008 Centralised - Notification EMEA/H/C/682/N/4
Updated with Decision(2010)4813 of 06/07/2010
14/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/682/IA/5
24/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/682/IA/6
25/05/2010 Centralised - Variation EMEA/H/C/682/IA/8
Updated with Decision(2010)4813 of 06/07/2010
12/07/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/682/T/7 (2010)4813 of 06/07/2010
04/10/2010 Centralised - Notification EMEA/H/C/682/N/9
Updated with Decision(2011)5293 of 18/07/2011
16/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/682/IA/10/G
20/07/2011 Centralised - Renewal EMEA/H/C/682/R/12 (2011)5293 of 18/07/2011
24/07/2012 Centralised - Variation EMEA/H/C/682/II/13/G (2012)5280 of 20/07/2012
27/08/2013 Centralised - Notification EMEA/H/C/682/N/15
Updated with Decision(2014)5251 of 18/07/2014
23/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/682/T/14 (2013)6221 of 19/09/2013
30/04/2014 Centralised - Variation EMEA/H/C/682/IA/16G
Updated with Decision(2014)5251 of 18/07/2014
22/07/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/682/T/17 (2014)5251 of 18/07/2014
14/01/2015 PSUSA - Modification EMEA/H/C/682/PSUSA/1001 (2015)106 of 12/01/2015
26/03/2015 Centralised - Variation
30/04/2015 Centralised - Variation EMEA/H/C/682/IA/23/G