Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Adrovance   
Auth. number : EU/1/06/364
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: Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
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
09/01/2007 Centralised - Authorisation EMEA/H/C/759 (2007)26 of 04/01/2007
02/04/2007 Centralised - Variation EMEA/H/C/759/N/2
Updated with Decision(2007)4599 of 02/10/2007
04/10/2007 Centralised - Variation EMEA/H/C/759/X/1 (2007)4599 of 02/10/2007
07/11/2007 Centralised - Variation EMEA/H/C/759/II/3 (2007)5429 of 31/10/2007
25/01/2008 Centralised - Variation EMEA/H/C/759/N/5
Updated with Decision(2008)4278 of 31/07/2008
05/08/2008 Centralised - Variation EMEA/H/C/759/II/6 (2008)4278 of 31/07/2008
05/12/2008 Centralised - Variation EMEA/H/C/759/N/7
Updated with Decision(2009)2731 of 07/04/2009
14/04/2009 Centralised - Variation EMEA/H/C/759/II/8 (2009)2731 of 07/04/2009
07/07/2009 Centralised - Variation EMEA/H/C/759/II/9 (2009)5480 of 02/07/2009
21/07/2009 Centralised - Variation EMEA/H/C/759/II/10 (2009)5834 of 16/07/2009
02/11/2009 Centralised - Variation EMEA/H/C/759/II/11 (2009)8574 of 29/10/2009
07/05/2010 Centralised - Variation EMEA/H/C/759/IG/3
Updated with Decision(2010)8643 of 29/11/2010
14/09/2010 Centralised - Variation EMEA/H/C/759/IG/20
18/11/2010 Centralised - Variation EMEA/H/C/759/IG/27
Updated with Decision(2011)565 of 27/01/2011
06/12/2010 Centralised - Variation EMEA/H/C/759/WS/38 (2010)8643 of 29/11/2010
19/01/2011 Centralised - Variation EMEA/H/C/759/IG/40
01/02/2011 Centralised - Variation (2011)565 of 27/01/2011
23/03/2011 Centralised - Variation EMEA/H/C/759/WS/95 (2011)1934 of 18/03/2011
28/04/2011 Centralised - Variation EMEA/H/C/759/IG/60/G
Updated with Decision(2011)5060 of 07/07/2011
01/07/2011 Referral EMEA/H/C/759/A-20/12 (2011)4815 of 29/06/2011
11/07/2011 Centralised - Variation (2011)5060 of 07/07/2011
08/09/2011 Centralised - Variation EMEA/H/C/759/N/14
Updated with Decision(2011)8648 of 21/11/2011
23/11/2011 Centralised - Renewal EMEA/H/C/759/R/13 (2011)8648 of 21/11/2011
16/01/2012 Centralised - Variation EMEA/H/C/759/N/24
18/07/2013 Centralised - Variation EMEA/H/C/759/N/26