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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Zoledronic acid Accord   

   This product is authorised under a different brand name in the EU in the following languages:
   - Ácido zoledrónico Accord (PT)
Auth. number : EU/1/13/834
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: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
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
21/01/2014 Centralised - Authorisation EMEA/H/C/2667 (2014)317 of 16/01/2014
10/02/2015 Centralised - Variation EMEA/H/C/2667/IB/1
Updated with Decision(2016)839 of 08/02/2016
6/11/2015 Centralised - Variation EMEA/H/C/2667/IB/2
Updated with Decision(2016)839 of 08/02/2016
10/02/2016 Centralised - Yearly update (2016)839 of 8/02/2016
2/08/2016 Centralised - Variation EMEA/H/C/2667/IB/4/G
Updated with Decision(2017)5092 of 13/07/2017
17/07/2017 Centralised - Yearly update (2017)5092 of 13/07/2017
4/08/2017 Centralised - Variation EMEA/H/C/2667/IB/5