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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ibandronic acid Accord   

   This product is authorised under a different brand name in the EU in the following languages:
   - Ибандронова киселина Accord (BG)
   - Ibandronsyre Accord (DA)
   - Ácido Ibandrónico Accord (ES)
   - Ácido Ibandrónico Accord (PT)
   - Acid ibandronic (RO)
   - Ibandronska kislina Accord (SL)
Auth. number : EU/1/12/798
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 is indicated in adults 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: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, 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
23/11/2012 Centralised - Authorisation EMEA/H/C/2638 (2012)8601 of 19/11/2012
03/01/2013 Centralised - Variation EMEA/H/C/2638/IAin/1/G
Updated with Decision(2014)79 of 08/01/2014
02/05/2013 Centralised - Variation EMEA/H/C/2638/IB/2
Updated with Decision(2014)79 of 08/01/2014
10/01/2014 Centralised - Yearly update (2014)79 of 08/01/2014
04/07/2014 Centralised - Variation EMEA/H/C/2638/IB/8
Updated with Decision(2015)2124 of 23/03/2015
25/03/2015 Centralised - Variation EMEA/H/C/2638/X/6 (2015)2124 of 23/03/2015
11/09/2015 Centralised - Variation EMEA/H/C/2638/IB/9
Updated with Decision(2016)5367 of 12/08/2016
20/06/2016 Centralised - Variation EMEA/H/C/2638/IB/11
Updated with Decision(2016)5367 of 12/08/2016
17/08/2016 Centralised - Yearly update (2016)5367 of 12/08/2016
17/01/2017 Centralised - Variation EMEA/H/C/2638/IA/12
Updated with Decision(2017)6433 of 18/09/2017
20/09/2017 Centralised - Renewal EMEA/H/C/2638/R/13 (2017)6433 of 18/09/2017