Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Bondronat   
Auth. number : EU/1/96/012
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: Bondronat is indicated for
- Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
-Treatment of tumour-induced hypercalcaemia with or without metastases.
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
27/06/1996 Centralised - Authorisation EMEA/H/C/101 (96)1689 of 25/06/1996
28/10/1996 Centralised - Authorisation EMEA/H/C/101/II/2 (96)2979 of 25/10/1996
28/08/1997 Centralised - Authorisation EMEA/H/C/101/II/4 (97)2751 of 27/08/1997
22/09/1998 Centralised - Notification EMEA/H/C/101/N/7,8 (1998)2697 of 18/09/1998
08/04/1999 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/101/T/11 (1999)876 of 29/03/1999
18/05/1999 Centralised - Variation EMEA/H/C/101/I/12 (1999)1293 of 11/05/1999
19/07/1999 Centralised - Variation EMEA/H/C/101/I/13, EMEA/H/C/101/N/14 (1999)3794 of 16/11/1999
29/06/2000 Centralised - Notification EMEA/H/C/101/N/15 (2000)1509 of 27/06/2000
25/04/2001 Centralised - Variation EMEA/H/C/101/I/16 (2001)850 of 23/04/2001
14/09/2001 Centralised - Renewal EMEA/H/C/101/R/18, 20 (2001)2195 of 12/09/2001
14/09/2001 Centralised - Variation EMEA/H/C/101/X/17 (2001)2199 of 13/09/2001
10/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/101/I/21
28/10/2003 Centralised - Variation EMEA/H/C/101/X/23 (2003)4010 of 24/10/2003
07/11/2003 Centralised - Variation EMEA/H/C/101/II/25 (2003)4133 of 31/10/2003
11/11/2003 Centralised - Variation EMEA/H/C/101/II/22 (2003)4175 of 07/11/2003
13/01/2004 Centralised - Variation EMEA/H/C/101/IB/26
Updated with Decision(2004)4252 of 22/10/2004
18/06/2004 Centralised - Variation EMEA/H/C/101/IB/31
Updated with Decision(2004)4252 of 22/10/2004
22/06/2004 Centralised - Notification EMEA/H/C/101/N/27
Updated with Decision(2004)4252 of 22/10/2004
13/07/2004 Centralised - Variation EMEA/H/C/101/IA/32
Updated with Decision(2004)4252 of 22/10/2004
26/10/2004 Centralised - Variation EMEA/H/C/101/II/29 (2004)4252 of 22/10/2004
19/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/101/IA/34
10/05/2005 Centralised - Variation EMEA/H/C/101/IA/35
Updated with Decision(2006)72 of 13/01/2006
30/06/2005 Centralised - Variation EMEA/H/C/101/IB/36
Updated with Decision(2006)72 of 13/01/2006
16/11/2005 Centralised - Variation EMEA/H/C/101/IA/37
Updated with Decision(2006)2997 of 26/06/2006
17/01/2006 Centralised - Variation (2006)72 of 13/01/2006
23/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/101/IA/39
28/06/2006 Centralised - Renewal EMEA/H/C/101/R/38 (2006)2997 of 26/06/2006
07/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/101/IB/40
15/12/2006 Centralised - Variation EMEA/H/C/101/IA/43
Updated with Decision(2007)831 of 06/03/2007
08/03/2007 Centralised - Variation EMEA/H/C/101/II/42 (2007)831 of 06/03/2007
24/09/2007 Centralised - Variation EMEA/H/C/101/IB/44
Updated with Decision(2008)1350 of 04/04/2008
09/04/2008 Centralised - Variation (2008)1350 of 04/04/2008
17/03/2009 Centralised - Variation EMEA/H/C/101/IB/45
Updated with Decision(2009)9329 of 20/11/2009
15/06/2009 Centralised - Variation EMEA/H/C/101/IA/46
Updated with Decision(2009)9329 of 20/11/2009
24/11/2009 Centralised - Variation (2009)9329 of 20/11/2009
06/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/101/II/48
06/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/101/II/47
27/01/2010 Centralised - Variation EMEA/H/C/101/II/49, 50 (2010)521 of 25/01/2010
11/03/2011 Centralised - Notification EMEA/H/C/101/N/52
Updated with Decision(2011)2793 of 14/04/2011
18/04/2011 Centralised - Variation EMEA/H/C/101/WS/86 (2011)2793 of 14/04/2011
01/07/2011 Referral EMEA/H/C/101/A-20/51 (2011)4803 of 29/06/2011
28/07/2011 Centralised - Variation EMEA/H/C/101/WS/144 (2011)5526 of 26/07/2011
08/09/2011 Centralised - Notification EMEA/H/C/101/N/55
Updated with Decision(2013)8837 of 03/12/2013
15/11/2012 Centralised - Variation EMEA/H/C/101/II/59
Updated with Decision(2013)8837 of 03/12/2013
27/11/2013 Centralised - Notification EMEA/H/C/101/N/63
06/12/2013 Centralised - Yearly update (2013)8837 of 03/12/2013
20/03/2014 Centralised - Variation EMEA/H/C/101/II/64