Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zoledronic acid Teva   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Zoledronsyre Teva (DA)
   - Zoledronsäure Teva (DE)
   - Ácido Zoledrónico Teva (ES)
   - Acide Zolédronique Teva (FR)
   - Zoledronsav Teva (HU)
   - Acido Zoledronico Teva (IT)
   - Zoledroninezuur Teva (NL)
   - Ácido Zoledrónico Teva (PT)
   - Acid zoledronic Teva (RO)
   - Kyselina zoledrónová Teva (SK)
   - Zoledronska kislina Teva (SL)
Auth. number : EU/1/12/771
INN : zoledronic 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: M05BA08 - Zoledronic acid
(See WHO ATC Index)
Indication:
  • Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
  • Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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
20/08/2012 Centralised - Authorisation EMEA/H/C/2439 (2012)5892 of 16/08/2012
17/01/2013 Centralised - Variation EMEA/H/C/2439/IB/4
Updated with Decision(2014)4500 of 27/06/2014
15/07/2013 Centralised - Variation EMEA/H/C/2439/IB/5
Updated with Decision(2014)4500 of 27/06/2014
19/03/2014 Centralised - Variation EMEA/H/C/2439/IB/9
Updated with Decision(2014)4500 of 27/06/2014
30/04/2014 Centralised - Variation EMEA/H/C/2439/IA/10
Updated with Decision(2014)4500 of 27/06/2014
02/07/2014 Centralised - Yearly update (2014)4500 of 27/06/2014
03/10/2014 Centralised - Variation EMEA/H/C/2439/X/8 (2014)7190 of 01/10/2014