Navigation path

Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Iasibon   
Auth. number : EU/1/10/659
INN : Ibandronic acid
ATC: M - Musculo-skeletal system
M05 - Drugs for treatment of bone diseases
M05B - Drugs affecting bone structure and mineralization
M05BA - Biphosphonates
M05BA06 - Ibandronic acid
(See WHO ATC Index)
Indication: 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: Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

  EPAR and active package presentations

Package presentations

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be 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
25/01/2011 Centralised - Authorisation EMEA/H/C/2025 (2011)389 of 21/01/2011
21/12/2011 Centralised - Variation EMEA/H/C/2025/IB/2G
Updated with Decision(2012)4758 of 04/07/2012
13/02/2012 Centralised - Variation EMEA/H/C/2025/N/4
Updated with Decision(2012)4758 of 04/07/2012
23/05/2012 Centralised - Variation EMEA/H/C/2025/N/5
Updated with Decision(2012)4758 of 04/07/2012
06/07/2012 Centralised - Variation - (2012)4758 of 04/07/2012
28/02/2013 Centralised - Variation EMEA/H/C/2025/N/8