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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ibandronic Acid Teva   

   This product is authorised under a different brand name in the EU in the following languages:
   - Ibandronsyre Teva (DA)
   - Ibandronsäure Teva (DE)
   - Ácido ibandrónico Teva (ES)
   - Acide ibandronique Teva (FR)
   - Ibandronsav Teva (HU)
   - Acido Ibandronico Teva (IT)
   - Ibandroninezuur Teva (NL)
   - Ácido Ibandrónico Teva (PT)
   - Acid ibandronic Teva (RO)
   - Kyselina ibandronová Teva (SK)
   - Ibandronska kislina Teva (SL)
Auth. number : EU/1/10/642
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 Teva 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.
Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
21/09/2010 Centralised - Authorisation EMEA/H/C/1195 (2010)6479 of 17/09/2010
25/01/2011 Corrigendum (2010)6479 cor of 21/01/2011
01/07/2011 Referral EMEA/H/C/1195/A-20/1 (2011)4798 of 29/06/2011
27/07/2011 Centralised - Variation EMEA/H/C/1195/IB/2
Updated with Decision(2012)3211 of 10/05/2012
28/10/2011 Centralised - Variation EMEA/H/C/1195/IB/3/G
Updated with Decision(2012)3211 of 10/05/2012
14/05/2012 Centralised - Variation (2012)3211 of 10/05/2012
20/06/2012 Centralised - Variation EMEA/H/C/1195/IA/5/G
Updated with Decision(2012)7853 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7853 of 29/10/2012
05/06/2013 Centralised - Variation EMEA/H/C/1195/IB/6
Updated with Decision(2014)4503 of 27/06/2014
12/03/2014 Centralised - Variation EMEA/H/C/1195/IB/9
Updated with Decision(2014)4503 of 27/06/2014
02/07/2014 Centralised - Yearly update (2014)4503 of 27/06/2014
03/12/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1195/T/11 (2014)9299 of 01/12/2014
29/06/2015 Centralised - Renewal EMEA/H/C/1195/R/12 (2015)4490 of 25/06/2015
24/09/2015 Centralised - Variation EMEA/H/C/1195/IB/13/G
Updated with Decision(2016)5963 of 15/09/2016
14/12/2015 Centralised - Variation EMEA/H/C/1195/IAIN/14
Updated with Decision(2016)5963 of 15/09/2016
25/04/2016 Centralised - Variation EMEA/H/C/1195/IA/15
Updated with Decision(2016)5963 of 15/09/2016
19/09/2016 Centralised - Yearly update (2016)5963 of 15/09/2016
10/11/2016 Centralised - Variation EMEA/H/C/1195/IB/16
Updated with Decision(2017)7169 of 30/10/2017
02/11/2017 Centralised - Yearly update (2017)7169 of 30/10/2017