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Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Zoledronic acid Teva Pharma   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Zoledronsyre Teva Pharma (DA)
   - Zoledronsäure Teva Pharma (DE)
   - Ácido Zoledronico Teva Pharma (ES)
   - Acide Zolédronique Teva Pharma (FR)
   - Zoledronsav Teva Pharma (HU)
   - Acido zoledronico Teva Pharma (IT)
   - Zoledroninezuur Teva Pharma (NL)
   - Ácido Zoledrónico Teva Pharma (PT)
   - Acid zoledronic Teva Pharma (RO)
   - Kyselina zoledrónová Teva Pharma (SK)
   - Zoledronska kislina Teva Pharma (SL)
Auth. number : EU/1/12/772
INN : zoledronic acid
ATC: M - Musculo-skeletal system
M05 - Drugs for treatment of bone diseases
M05B - Drugs affecting bone structure and mineralization
M05BA - Biphosphonates
M05BA08 - Zoledronic acid
(See WHO ATC Index)
Indication: Treatment of osteoporosis
  • in post-menopausal women
  • in men
at increased risk of fracture.

Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
  • in post-menopausal women
  • in men
at increased risk of fracture.

Treatment of Paget’s disease of the bone in adults.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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
20/08/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2437 (2012)5893 of 16/08/2012
20/08/2012 Centralised - Authorisation EMEA/H/C/2437 (2012)5894 of 16/08/2012
08/11/2012 Centralised - Variation EMEA/H/C/2437/IB/1
29/01/2013 Centralised - Variation EMEA/H/C/2437/IB/2