Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ibandronic acid Sandoz   

   This product is authorized under a different brandname in the EU in the folowing 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
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: indicated 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 Pharmaceuticals GmbH
Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

  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