Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Iasibon   
Auth. number : EU/1/10/659
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: 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

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
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
Updated with Decision(2014)3532 of 22/05/2014
27/05/2013 Centralised - Variation EMEA/H/C/2025/IB/9
Updated with Decision(2014)3532 of 22/05/2014
07/04/2014 Centralised - Variation EMEA/H/C/2025/N/11
Updated with Decision(2014)3532 of 22/05/2014
27/05/2014 Centralised - Variation (2014)3532 of 22/05/2014