Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zoledronic acid Mylan   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Zoledronsyre Mylan (DA)
   - Zoledronsäure Mylan (DE)
   - Ácido zoledrónico Mylan (ES)
   - Acide zolédronique Mylan (FR)
   - Zoledronsav Mylan (HU)
   - Acido zoledronico Mylan (IT)
   - Zoledroninezuur Mylan (NL)
   - Ácido Zoledrónico Mylan (PT)
   - Zolendronska kislina Mylan (SL)
Auth. number : EU/1/12/786
INN : 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: Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France

  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
27/08/2012 Centralised - Authorisation EMEA/H/C/2482 (2012)6033 of 23/08/2012
17/01/2013 Centralised - Variation EMEA/H/C/2482/IB/1
Updated with Decision(2014)1257 of 20/02/2014
31/05/2013 Centralised - Variation EMEA/H/C/2482/IAin/2/G
Updated with Decision(2014)1257 of 20/02/2014
19/08/2013 Centralised - Variation EMEA/H/C/2482/IB/3
Updated with Decision(2014)1257 of 20/02/2014
03/02/2014 Centralised - Variation EMEA/H/C/2482/IB/4
Updated with Decision(2014)1257 of 20/02/2014
24/02/2014 Centralised - Variation (2014)1257 of 20/02/2014