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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Zoledronic acid Hospira   

   This product is authorised under a different brand name in the EU in the following languages:
   - Ácido Zoledrónico Hospira (PT)
Auth. number : EU/1/12/800
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: Zoledronic Acid Hospira 4 mg/5 ml and 4 mg/100 ml:
  • 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)
Zoledronic Acid Hospira 5 mg/100 ml:
  • Treatment of Paget’s disease of the bone in adults.
Marketing Authorisation Holder: Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, 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
23/11/2012 Centralised - Authorisation EMEA/H/C/2365 (2012)8605 of 19/11/2012
19/04/2013 Centralised - Variation EMEA/H/C/2365/IB/1
Updated with Decision(2014)642 of 31/01/2014
16/07/2013 Centralised - Variation EMEA/H/C/2365/IB/4
Updated with Decision(2014)642 of 31/01/2014
04/02/2014 Centralised - 2-Monthly update EMEA/H/C/2365/IB/8/G (2014)642 of 31/01/2014
01/04/2014 Centralised - Variation EMEA/H/C/2365/IB/10
Updated with Decision(2015)877 of 11/02/2015
25/07/2014 Centralised - Variation EMEA/H/C/2365/IB/12
Updated with Decision(2015)877 of 11/02/2015
19/12/2014 Centralised - Variation EMEA/H/C/2365/IB/15
Updated with Decision(2015)877 of 11/02/2015
13/02/2015 Centralised - Yearly update (2015)877 of 11/02/2015
01/07/2015 Centralised - Variation EMEA/H/C/2365/IB/17/G
Updated with Decision(2016)4075 of 24/06/2016
27/10/2015 Centralised - Variation EMEA/H/C/2365/IB/18
Updated with Decision(2016)4075 of 24/06/2016
10/12/2015 Centralised - Variation EMEA/H/C/2365/IAin/19/G
Updated with Decision(2016)4075 of 24/06/2016
17/06/2016 Centralised - Notification EMEA/H/C/2365/N/22
Updated with Decision(2017)4312 of 16/06/2017
28/06/2016 Centralised - Yearly update (2016)4075 of 24/06/2016
19/08/2016 Centralised - Variation EMEA/H/C/2365/IB/23
Updated with Decision(2017)4312 of 16/06/2017
16/02/2017 Centralised - Notification EMEA/H/C/2365/N/25
Updated with Decision(2017)4312 of 16/06/2017
20/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/3149/201608 (2017)4312 of 16/06/2017
29/08/2017 Centralised - Renewal EMEA/H/C/2365/R/26 (2017)5933 of 24/08/2017
13/11/2017 Centralised - Notification EMEA/H/C/2365/N/28
07/12/2017 Centralised - Variation EMEA/H/C/2365/IAIN/30
12/02/2018 Centralised - Variation EMEA/H/C/2365/IAIN/31_G