Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Bonviva   
Auth. number : EU/1/03/265
INN : Ibandronic acid
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: M05BA - Biphosphonates
Chemical substance: M05BA06 - Ibandronic acid
(See WHO ATC Index)
Indication: Treatment of osteoporosis in postmenopausal women
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
26/02/2004 Centralised - Authorisation EMEA/H/C/501 (2004)636 of 23/02/2004
19/10/2004 Centralised - Variation EMEA/H/C/501/IB/2
Updated with Decision(2005)1545 of 18/05/2005
24/05/2005 Centralised - Variation EMEA/H/C/501 (2005)1545 of 18/05/2005
20/09/2005 Centralised - Variation EMEA/H/C/501/X/1 (2005)3582 of 15/09/2005
25/10/2005 Centralised - Variation EMEA/H/C/501/IA/4
Updated with Decision(2006)1352 of 29/03/2006
26/10/2005 Centralised - Variation EMEA/H/C/501/N/5
Updated with Decision(2006)1352 of 29/03/2006
08/11/2005 Corrigendum EMEA/H/C/501/X/1 (2005)3583 corr of 28/10/2005
31/03/2006 Centralised - Variation EMEA/H/C/501/X/3 (2006)1352 of 29/03/2006
14/06/2006 Centralised - Variation EMEA/H/C/501/IA/9
05/07/2006 Centralised - Variation EMEA/H/C/501/IB/10
02/08/2006 Centralised - Variation EMEA/H/C/501/II/8 (2006)3537 of 28/07/2006
17/08/2006 Centralised - Variation EMEA/H/C/501/IB/11
31/08/2006 Centralised - Variation EMEA/H/C/501/II/7 (2006)3919 of 28/08/2006
13/09/2006 Centralised - Variation EMEA/H/C/501/IA/12
Updated with Decision(2007)1913 of 25/04/2007
27/10/2006 Centralised - Variation EMEA/H/C/501/N/14
Updated with Decision(2007)1913 of 25/04/2007
08/01/2007 Centralised - Variation EMEA/H/C/501/IB/13
Updated with Decision(2007)1913 of 25/04/2007
17/01/2007 Centralised - Variation EMEA/H/C/501/N/15
Updated with Decision(2007)1913 of 25/04/2007
30/04/2007 Centralised - Variation (2007)1913 of 25/04/2007
14/07/2008 Centralised - Variation EMEA/H/C/501/II/16 (2008)3654 of 10/07/2008
25/02/2009 Centralised - Renewal EMEA/H/C/501/R/17 (2009)1311 of 23/02/2009
05/05/2009 Centralised - Variation EMEA/H/C/501/IA/19
Updated with Decision(2009)5479 of 02/07/2009
25/05/2009 Centralised - Variation EMEA/H/C/501/N/20
Updated with Decision(2009)5479 of 02/07/2009
07/07/2009 Centralised - Variation EMEA/H/C/501/II/18 (2009)5479 of 02/07/2009
16/12/2009 Centralised - Variation EMEA/H/C/501/IB/22
Updated with Decision(2010)891 of 08/02/2010
10/02/2010 Centralised - Variation EMEA/H/C/501/II/21 (2010)891 of 08/02/2010
07/05/2010 Centralised - Variation EMEA/H/C/501/II/23 (2010)3066 of 05/05/2010
19/04/2011 Centralised - Variation EMEA/H/C/501/WS/86 (2011)2803 of 14/04/2011
01/07/2011 Referral EMEA/H/C/501/A-20/24 (2011)4795 of 29/06/2011
29/07/2011 Centralised - Variation EMEA/H/C/501/WS/144 (2011)5581 of 27/07/2011
28/10/2011 Centralised - Variation EMEA/H/C/501/N/25
Updated with Decision(2013)9730 of 18/12/2013
15/11/2012 Centralised - Variation EMEA/H/C/501/II/34
Updated with Decision(2013)9730 of 18/12/2013
20/12/2013 Centralised - Renewal EMEA/H/C/501/R/39 (2013)9730 of 18/12/2013