Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Osseor   
Auth. number : EU/1/04/287
Active substance : Strontium ranelate
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M05 - Drugs for treatment of bone diseases
Pharmacological subgroup: M05B - Drugs affecting bone structure and mineralization
Chemical subgroup: M05BX - Other drugs affecting bone structure and mineralization
Chemical substance: M05BX03 - Strontium ranelate
(See WHO ATC Index)
Indication: Treatment of severe osteoporosis:
- in postmenopausal women,
- in adult men,
at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures.
The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks
Marketing Authorisation Holder: Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, 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
23/09/2004 Centralised - Authorisation EMEA/H/C/561 (2004)3599 of 21/09/2004
07/03/2005 Centralised - Notification EMEA/H/C/561/N/1
Updated with Decision(2007)743 of 28/02/2007
04/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IB/2
29/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/3
20/12/2006 Centralised - Notification EMEA/H/C/561/N/4
Updated with Decision(2007)743 of 28/02/2007
02/03/2007 Centralised - Variation EMEA/H/C/561/II/5 (2007)743 of 28/02/2007
09/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IB/8
09/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IB/6
09/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IB/7
29/01/2008 Centralised - Variation EMEA/H/C/561/II/9 (2008)387 of 25/01/2008
26/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/13
26/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/12
26/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/10
26/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/11
23/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/15
23/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/14
24/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/17
24/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/16
24/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/18
11/03/2009 Centralised - Variation EMEA/H/C/561/II/19 (2009)1835 of 09/03/2009
31/07/2009 Centralised - Variation EMEA/H/C/561/II/21 (2009)6155 of 28/07/2009
06/11/2009 Centralised - Renewal EMEA/H/C/561/R/20 (2009)8659 of 04/11/2009
12/01/2010 Centralised - Variation EMEA/H/C/561/II/22 (2010)70 of 08/01/2010
29/03/2010 Corrigendum
21/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/23
31/08/2010 Centralised - Variation EMEA/H/C/561/II/24 (2010)6030 of 26/08/2010
15/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/561/IA/25
04/03/2011 Centralised - Variation EMEA/H/C/561/II/26 (2011)1502 of 28/02/2011
22/08/2011 Centralised - Variation EMEA/H/C/561/II/28 (2011)6051 of 18/08/2011
10/11/2011 Centralised - Variation EMEA/H/C/561/IA/29
Updated with Decision(2012)3572 of 25/05/2012
30/05/2012 Referral EMEA/H/C/561/A-20/30 (2012)3572 of 25/05/2012
02/07/2012 Centralised - Variation EMEA/H/C/561/II/27 (2012)4516 of 27/06/2012
26/10/2012 Centralised - Variation EMEA/H/C/561/II/32 (2012)7608 of 23/10/2012
25/06/2013 PSUSA - Modification EMEA/H/C/561/PSU/31 (2013)4013 of 21/06/2013
17/12/2013 Centralised - Variation EMEA/H/C/561/IB/35
Updated with Decision(2014)2703 of 15/04/2014
17/04/2014 Referral EMEA/H/C/1371/A-20/561/34 (2014)2703 of 15/04/2014
27/05/2014 Centralised - Renewal EMEA/H/C/561/R/36 (2014)3537 of 22/05/2014
23/06/2014 PSUSA - Modification EMEA/H/C/561/PSUV/37 (2014)4274 of 19/06/2014
17/06/2015 Centralised - Notification EMEA/H/C/561/N/41