European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
Community Register of medicinal products
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: | V - Various V10 - Therapeutic radiopharmaceuticals V10B - Pain palliation (bone seeking agents) V10BX - Various pain palliation radiopharmaceuticals 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 - Variation | EMEA/H/C/150/N/4 | (2000)2799 of 09/10/2000 | |||
| 14/03/2001 | Centralised - Variation | EMEA/H/C/150/N/5 | (2001)521 of 13/03/2001 | |||
| 20/12/2001 | Centralised - Variation | EMEA/H/C/150/N/6 | (2001)4318 of 17/12/2001 | |||
| 23/04/2002 | Centralised - Variation | EMEA/H/C/150/N/7 | (2002)1575 of 19/04/2002 | |||
| 02/07/2002 | Centralised - Variation | 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 | EMEA/H/C/150/IA/11 | ||||
| 26/09/2006 | Centralised - Variation | EMEA/H/C/150/N/12 | ||||
| Updated with Decision(2007)6455 of 12/12/2007 | ||||||
| 17/04/2007 | Centralised - Variation | 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 - Variation | 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 |