Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fosavance   
Auth. number : EU/1/05/310
INN : Alendronate Sodium / Colecalciferol
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: M05BB - Bisphosphonates, combinations
Chemical substance: M05BB03 - Alendronic acid and colecalciferol
(See WHO ATC Index)
Indication: FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. FOSAVANCE reduces the risk of vertebral and hip fractures.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
26/08/2005 Centralised - Authorisation EMEA/H/C/619 (2005)3272 of 24/08/2005
01/11/2006 Centralised - Variation EMEA/H/C/619/II/1 (2006)5331 of 30/10/2006
20/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/619/II/2
04/01/2007 Centralised - Notification EMEA/H/C/619/N/4
Updated with Decision(2007)4655 of 04/10/2007
11/10/2007 Centralised - Variation EMEA/H/C/619/X/3 (2007)4655 of 04/10/2007
26/10/2007 Centralised - Variation EMEA/H/C/619/II/5 (2007)5300 of 24/10/2007
06/12/2007 Corrigendum (2007)5300 corr of 04/12/2007
26/08/2008 Centralised - Variation EMEA/H/C/619/II/8 (2008)4654 of 22/08/2008
16/09/2008 Centralised - Notification EMEA/H/C/619/N/7
Updated with Decision(2008)4654 of 22/08/2008
15/10/2008 Corrigendum EMEA/H/C/619/II/8 (2008)6055 corr of 13/10/2008
04/12/2008 Centralised - Notification EMEA/H/C/619/N/9
Updated with Decision(2009)2860 of 07/04/2009
14/04/2009 Centralised - Variation EMEA/H/C/619/II/10 (2009)2860 of 07/04/2009
09/07/2009 Centralised - Variation EMEA/H/C/619/II/11 (2009)5603 of 07/07/2009
05/08/2009 Centralised - Variation EMEA/H/C/619/II/12 (2009)6283 of 03/08/2009
10/11/2009 Centralised - Variation EMEA/H/C/619/II/13 (2009)8751 of 06/11/2009
19/05/2010 Centralised - Variation EMEA/H/C/619/IG/3
Updated with Decision(2010)5777 of 16/08/2010
18/08/2010 Centralised - Renewal EMEA/H/C/619/R/14 (2010)5777 of 16/08/2010
14/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/619/IG/20
18/11/2010 Centralised - Variation EMEA/H/C/619/IG/27/G
Updated with Decision(2011)693 of 01/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/619/WS/38 (2010)8645 of 29/11/2010
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/619/IG/40
03/02/2011 Centralised - Variation (2011)693 of 01/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/619/WS/95 (2011)1918 of 18/03/2011
05/05/2011 Centralised - Variation EMEA/H/C/619/IG/60/G
Updated with Decision(2011)5585 of 27/07/2011
01/07/2011 Referral EMEA/H/C/619/A-20/15 (2011)4799 of 29/06/2011
29/07/2011 Centralised - Variation (2011)5585 of 27/07/2011
12/09/2011 Centralised - Notification EMEA/H/C/619/N/16
Updated with Decision(2012)3556 of 25/05/2012
30/05/2012 Centralised - Variation EMEA/H/C/619/WS/238 (2012)3556 of 25/05/2012
18/07/2013 Centralised - Notification EMEA/H/C/619/N/28