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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Zoledronic acid medac   

   This product is authorised under a different brand name in the EU in the following languages:
   - Золедронова киселина medac (BG)
   - Zoledronsyre medac (DA)
   - Zoledronsäure medac (DE)
   - Zoledroonhape medac (ET)
   - Tsoledronihappo medac (FI)
   - Acide zolédronique medac (FR)
   - Zoledronsav medac (HU)
   - Acido zoledronico medac (IT)
   - Zoledrono rūgštis medac (LT)
   - Zoledroninezuur medac (NL)
   - Acidum zolendronicum medac (PL)
   - Ácido zoledrónico medac (PT)
   - Acid zoledronic medac (RO)
   - Kyselina zoledrónová medac (SK)
   - Zoledronska kislina medac (SL)
   - Zoledronsyra medac (SV)
Auth. number : EU/1/12/779
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: medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland
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
7/08/2012 Centralised - Authorisation EMEA/H/C/2359 (2012)5695 of 3/08/2012
14/12/2012 Centralised - Variation EMEA/H/C/2359/IAIN/1
Updated with Decision(2013)8833 of 03/12/2013
14/12/2012 Centralised - Variation EMEA/H/C/2359/IB/2
Updated with Decision(2013)8833 of 03/12/2013
16/07/2013 Centralised - Variation EMEA/H/C/2359/IB/3
Updated with Decision(2013)8833 of 03/12/2013
6/12/2013 Centralised - Yearly update (2013)8833 of 3/12/2013
15/01/2014 Centralised - Variation EMEA/H/C/2359/IB/5
Updated with Decision(2015)208 of 15/01/2015
22/12/2014 Centralised - Variation EMEA/H/C/2359/IB/7/G
Updated with Decision(2015)4702 of 03/07/2015
19/01/2015 Centralised - Yearly update (2015)208 of 15/01/2015
7/07/2015 PSUSA - Modification EMEA/H/C/PSUSA/3149/201308 (2015)4702 of 3/07/2015
21/10/2015 Centralised - Variation EMEA/H/C/2359/IAIN/11
Updated with Decision(2016)4193 of 29/06/2016
2/12/2015 Centralised - Variation EMEA/H/C/2359/IAIN/13
Updated with Decision(2016)4193 of 29/06/2016
27/05/2016 Centralised - Variation EMEA/H/C/2359/IB/15/G
Updated with Decision(2017)2962 of 28/04/2017
1/07/2016 PSUSA - Modification EMEA/H/C/PSUSA/3149/201508 (2016)4193 of 29/06/2016
3/05/2017 Centralised - Renewal EMEA/H/C/2359/R/18 (2017)2962 of 28/04/2017
20/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/3149/201608 (2017)4313 of 16/06/2017