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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zoledronic acid Teva Pharma   

   This product is authorised 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
Active substance : 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: Treatment of osteoporosis
• in post-menopausal women
• in adult men
at increased risk of fracture, including those with a recent low-trauma hip fracture.

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

Treatment of Paget’s disease of the bone in adults.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, 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/2437 (2012)5894 of 16/08/2012
20/08/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2437 (2012)5893 of 16/08/2012
08/11/2012 Centralised - Variation EMEA/H/C/2437/IB/1
Updated with Decision(2013)8333 of 20/11/2013
29/01/2013 Centralised - Variation EMEA/H/C/2437/IB/2
Updated with Decision(2013)8333 of 20/11/2013
08/11/2013 Centralised - Variation EMEA/H/C/2437/IB/6
Updated with Decision(2013)8333 of 20/11/2013
22/11/2013 Centralised - Yearly update (2013)8333 of 20/11/2013
25/04/2014 Centralised - Variation EMEA/H/C/2437/IB/7
Updated with Decision(2014)10243 of 19/12/2014
06/08/2014 Centralised - Variation EMEA/H/C/2437/IB/8
Updated with Decision(2014)10243 of 19/12/2014
24/12/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2437/T/9 (2014)10243 of 19/12/2014
07/05/2015 Centralised - 2-Monthly update EMEA/H/C/2437/IB/10 (2015)3149 of 05/05/2015