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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ibandronic acid Sandoz   

   This product is authorised under a different brand name in the EU in the following languages:
   - Ibandronsyre Sandoz (DA)
   - Ibandronsäure Sandoz (DE)
   - Ácido ibandrónico Sandoz (ES)
   - Acide ibandronique Sandoz (FR)
   - Ibandronsav Sandoz (HU)
   - Acido Ibandronico Sandoz (IT)
   - Ibandroninezuur Sandoz (NL)
   - Ácido Ibandrónico Sandoz (PT)
   - Acid ibandronic Sandoz (RO)
   - Ibandronska kislina Sandoz (SL)
Auth. number : EU/1/11/685
Active substance : 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: Ibandronic acid Sandoz is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Marketing Authorisation Holder: Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich
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
28/07/2011 Centralised - Authorisation EMEA/H/C/2367 (2011)5530 of 26/07/2011
13/02/2012 Centralised - Variation EMEA/H/C/2367/IB/2G
Updated with Decision(2012)7984 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7984 of 31/10/2012
21/02/2013 Centralised - Notification EMEA/H/C/2367/N/6
Updated with Decision(2014)3814 of 03/06/2014
16/05/2013 Centralised - Variation EMEA/H/C/2367/IB/7
Updated with Decision(2014)3814 of 03/06/2014
05/06/2014 Centralised - Yearly update (2014)3814 of 03/06/2014
06/08/2014 Centralised - Variation EMEA/H/C/2367/IB/11
Updated with Decision(2015)2002 of 19/03/2015
23/03/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2367/T/13 (2015)2002 of 19/03/2015
11/09/2015 Centralised - Variation EMEA/H/C/2367/IB/14
Updated with Decision(2016)2272 of 13/04/2016
08/12/2015 Centralised - Variation EMEA/H/C/2367/IAIN/18
Updated with Decision(2016)2272 of 13/04/2016
15/04/2016 Centralised - Renewal EMEA/H/C/2367/R/17 (2016)2272 of 13/04/2016
21/07/2016 Centralised - Variation EMEA/H/C/2367/IB/19
Updated with Decision(2017)4657 of 29/06/2017
03/07/2017 Centralised - Yearly update (2017)4657 of 29/06/2017