Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Protelos   
Auth. number : EU/1/04/288
INN : 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/560 (2004)3592 of 21/09/2004
04/04/2005 Centralised - Variation EMEA/H/C/560/IB/1
09/11/2005 Centralised - Variation EMEA/H/C/560/N/2
29/05/2006 Centralised - Variation EMEA/H/C/560/IA/3
02/03/2007 Centralised - Variation EMEA/H/C/560/IB/4 (2007)746 of 28/02/2007
08/11/2007 Centralised - Variation EMEA/H/C/560/IB/5
08/11/2007 Centralised - Variation EMEA/H/C/560/IB/7
08/11/2007 Centralised - Variation EMEA/H/C/560/IB/6
29/01/2008 Centralised - Variation EMEA/H/C/560/II/8 (2008)388 of 25/01/2008
27/03/2008 Centralised - Variation EMEA/H/C/560/IA/13
27/03/2008 Centralised - Variation EMEA/H/C/560/IA/12
27/03/2008 Centralised - Variation EMEA/H/C/560/IA/14
27/03/2008 Centralised - Variation EMEA/H/C/560/IA/9
27/03/2008 Centralised - Variation EMEA/H/C/560/IA/11
27/03/2008 Centralised - Variation EMEA/H/C/560/IA/10
27/03/2008 Centralised - Variation EMEA/H/C/560/IA/15
23/04/2008 Centralised - Variation EMEA/H/C/560/IA/16
23/04/2008 Centralised - Variation EMEA/H/C/560/IA/17
23/04/2008 Centralised - Variation EMEA/H/C/560/IA/18
23/04/2008 Centralised - Variation EMEA/H/C/560/IA/19
24/10/2008 Centralised - Variation EMEA/H/C/560/IA/20
24/10/2008 Centralised - Variation EMEA/H/C/560/IA/21
24/11/2008 Centralised - Variation EMEA/H/C/560/IA/22
05/03/2009 Centralised - Variation EMEA/H/C/560/IA/25
10/03/2009 Centralised - Variation EMEA/H/C/560/II/23 (2009)1714 of 06/03/2009
31/07/2009 Centralised - Variation EMEA/H/C/560/II/26 (2009)6157 of 28/07/2009
06/11/2009 Centralised - Renewal EMEA/H/C/560/R/24 (2009)8658 of 04/11/2009
12/01/2010 Centralised - Variation EMEA/H/C/560/II/27 (2010)72 of 08/01/2010
21/04/2010 Centralised - Variation EMEA/H/C/560/IA/28
31/08/2010 Centralised - Variation EMEA/H/C/560/II/29 (2010)6029 of 26/08/2010
04/03/2011 Centralised - Variation EMEA/H/C/560/II/30 (2011)1503 of 28/02/2011
22/08/2011 Centralised - Variation EMEA/H/C/560/II/32 (2011)6052 of 18/08/2011
10/11/2011 Centralised - Variation EMEA/H/C/560/IA/33
Updated with Decision(2012)3573 of 25/05/2012
30/05/2012 Referral EMEA/H/C/560/A-20/34 (2012)3573 of 25/05/2012
02/07/2012 Centralised - Variation EMEA/H/C/560/II/31 (2012)4518 of 27/06/2012
31/07/2012 Centralised - Variation EMEA/H/C/560/IAin/37
Updated with Decision(2012)7609 of 23/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/560/II/36 (2012)7609 of 23/10/2012
25/06/2013 Centralised - Modification EMEA/H/C/560/PSU/31 (2013)4012 of 21/06/2013
17/12/2013 Centralised - Variation EMEA/H/C/560/IB/40
Updated with Decision(2014)2704 of 15/04/2014
17/04/2014 Referral EMEA/H/A20/1371/C/560/39 (2014)2704 of 15/04/2014
27/05/2014 Centralised - Renewal EMEA/H/C/560/R/41 (2014)3538 of 22/05/2014
23/06/2014 Centralised - Modification EMEA/H/C/560/PSUV/42 (2014)4273 of 19/06/2014