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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Zoledronic acid Actavis   

   This product is authorised under a different brand name in the EU in the following languages:
   - Zoledronsäure Actavis (DE)
   - Acido zoledrónico Actavis (ES)
   - Acide zolédronique Actavis (FR)
   - Zoledronsav Actavis (HU)
   - Acido zoledronico Actavis (IT)
   - Acido Zoledrónico Actavis (PT)
   - Acid zoledronic Actavis (RO)
   - Zoledronska kislina Actavis (SL)
Auth. number : EU/1/12/759
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: - 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: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland
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
26/04/2012 Centralised - Authorisation EMEA/H/C/2488 (2012)2851 of 20/04/2012
10/01/2013 Centralised - Variation EMEA/H/C/2488/IB/1
Updated with Decision(2014)1259 of 20/02/2014
16/07/2013 Centralised - Variation EMEA/H/C/2488/IB/2
Updated with Decision(2014)1259 of 20/02/2014
16/08/2013 Centralised - Variation EMEA/H/C/2488/IB/3
Updated with Decision(2014)1259 of 20/02/2014
15/01/2014 Centralised - Variation EMEA/H/C/2488/IB/4
Updated with Decision(2014)1259 of 20/02/2014
24/02/2014 Centralised - Yearly update (2014)1259 of 20/02/2014
13/08/2014 Centralised - Notification EMEA/H/C/2488/N/5
Updated with Decision(2015)9262 of 10/12/2015
08/01/2015 Centralised - Variation EMEA/H/C/2488/IB/6
Updated with Decision(2015)9262 of 10/12/2015
09/10/2015 Centralised - Variation EMEA/H/C/2488/IB/11
Updated with Decision(2015)9262 of 10/12/2015
14/12/2015 Centralised - Variation EMEA/H/C/2488/IAIN/13
Updated with Decision(2016)8532 of 08/12/2016
14/12/2015 Centralised - Yearly update (2015)9262 of 10/12/2015
07/07/2016 Centralised - Variation EMEA/H/C/2488/IB/16
Updated with Decision(2016)8532 of 08/12/2016
12/12/2016 Centralised - Renewal EMEA/H/C/2488/R/17 (2016)8532 of 08/12/2016
03/10/2017 Centralised - Variation EMEA/H/C/2488/IB/18