Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Quadramet   
Auth. number : EU/1/97/057
INN : Samarium [153 Sm] lexidronam pentasodium
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V10 - Therapeutic radiopharmaceuticals
Pharmacological subgroup: V10B - Pain palliation (bone seeking agents)
Chemical subgroup: V10BX - Various pain palliation radiopharmaceuticals
Chemical substance: V10BX02 - Samarium (153Sm) lexidronam
(See WHO ATC Index)
Indication: QUADRAMET is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan.
The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.
Marketing Authorisation Holder: CIS bio international
route Nationale 306, Saclay, Boite Postale 32, F-91192 Gif-sur-Yvette, France

  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
10/02/1998 Centralised - Authorisation EMEA/H/C/150 (1998)253 of 05/02/1998
12/10/2000 Centralised - Notification EMEA/H/C/150/N/4 (2000)2799 of 09/10/2000
14/03/2001 Centralised - Notification EMEA/H/C/150/N/5 (2001)521 of 13/03/2001
20/12/2001 Centralised - Notification EMEA/H/C/150/N/6 (2001)4318 of 17/12/2001
23/04/2002 Centralised - Notification EMEA/H/C/150/N/7 (2002)1575 of 19/04/2002
02/07/2002 Centralised - Notification EMEA/H/C/150/N/8 (2002)2534 of 27/06/2002
20/03/2003 Centralised - Renewal EMEA/H/C/150/R/9 (2003)857 of 17/03/2003
24/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/150/IA/11
26/09/2006 Centralised - Notification EMEA/H/C/150/N/12
Updated with Decision(2007)6455 of 12/12/2007
17/04/2007 Centralised - Notification EMEA/H/C/150/N/13
Updated with Decision(2007)6455 of 12/12/2007
14/12/2007 Centralised - Renewal EMEA/H/C/150/R/14 (2007)6455 of 12/12/2007
11/04/2008 Centralised - Notification EMEA/H/C/150/N/15
Updated with Decision(2008)4023 of 23/07/2008
25/07/2008 Centralised - Variation EMEA/H/C/150/II/16 (2008)4023 of 23/07/2008
06/08/2010 Centralised - Variation EMEA/H/C/150/IG/15
Updated with Decision(2011)1507 of 28/02/2011
04/04/2011 Centralised - Variation (2011)1507 of 28/02/2011
18/06/2012 Centralised - Variation EMEA/H/C/150/II/18 (2012)4181 of 14/06/2012