Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vantavo   
Auth. number : EU/1/09/572
INN : alendronic acid / 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 women at risk of vitamin D insufficiency.
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
20/10/2009 Centralised - Authorisation EMEA/H/C/1180 (2009)8137 of 16/10/2009
17/03/2010 Centralised - Variation EMEA/H/C/1180/II/1 (2010)1770 of 15/03/2010
06/04/2010 Centralised - Variation EMEA/H/C/1180/IA/2
Updated with Decision(2010)7533 of 25/10/2010
16/07/2010 Centralised - Variation EMEA/H/C/1180/N/4
Updated with Decision(2010)7533 of 25/10/2010
30/09/2010 Centralised - Variation EMEA/H/C/1180/IG/20
07/10/2010 Centralised - Variation EMEA/H/C/1180/IG/3
Updated with Decision(2010)7533 of 25/10/2010
27/10/2010 Centralised - Variation (2010)7533 of 25/10/2010
24/11/2010 Centralised - Variation EMEA/H/C/1180/IG/27/G
Updated with Decision(2011)725 of 02/02/2011
02/12/2010 Centralised - Variation EMEA/H/C/1180/WS/38 (2010)8633 of 29/11/2010
25/01/2011 Centralised - Variation EMEA/H/C/1180/IG/40
04/02/2011 Centralised - Variation (2011)725 of 02/02/2011
28/03/2011 Centralised - Variation EMEA/H/C/1180/WS/95 (2011)2081 of 24/03/2011
24/05/2011 Centralised - Variation EMEA/H/C/1180/IG/60/G
Updated with Decision(2011)5595 of 27/07/2011
01/07/2011 Referral EMEA/H/C/1180/A-20/5 (2011)4806 of 29/06/2011
01/08/2011 Centralised - Variation (2011)5595 of 27/07/2011
15/09/2011 Centralised - Variation EMEA/H/C/1180/N/6
Updated with Decision(2012)3579 of 25/05/2012
30/05/2012 Centralised - Variation EMEA/H/C/1180/WS/238 (2012)3579 of 25/05/2012
18/07/2013 Centralised - Variation EMEA/H/C/1180/N/17