Zoledronic acid medac

Withdrawn

This medicine's authorisation has been withdrawn

zoledronic acid

Overview

On 13 March 2026, the European Commission withdrew the marketing authorisation for Zoledronic acid medac (zoledronic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, medac Gesellschaft fur klinische Spezialpraparate mbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Zoledronic acid medac was granted marketing authorisation in the EU on 3 August 2012 for the prevention of skeletal related events and the treatment of tumour-induced hypercalcaemia (TIH). The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017.

Zoledronic acid medac is a generic medicine of Zometa. There are other generic medicines of Zometa authorised and marketed in the EU. 

Zoledronic acid Medac : EPAR - Summary for the public

Reference Number: EMA/394066/2012

Product information

Zoledronic acid Medac : EPAR - Product Information

Zoledronic acid Medac : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zoledronic acid medac
• Active substance:
  zoledronic acid monohydrate
• International non-proprietary name (INN) or common name:
  zoledronic acid
• Therapeutic area (MeSH):
  • Fractures, Bone
  • Cancer
• Anatomical therapeutic chemical (ATC) code:
  M05BA08

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic 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).

Authorisation details

• EMA product number:
  EMEA/H/C/002359
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  medac Gesellschaft für klinische Spezialpräparate mbH

  Theaterstrasse 6; 22880 Wedel; Germany

• Opinion adopted:
  24/05/2012
• Marketing authorisation issued:
  03/08/2012
• Withdrawal of marketing authorisation:
  13/03/2026
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Zoledronic acid medac : EPAR - Procedural steps taken and scientific information after authorisation

Zoledronic acid Medac-H-C-PSUSA-00003149-202308 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/113943/2026

Zoledronic acid medac-H-C-PSUSA-3149-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/321879/2017

Zoledronic acid medac-H-C-PSUSA-00003149-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/300110/2015

Initial marketing authorisation documents

Zoledronic acid Medac : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/271077/2012

CHMP positive summary of opinion for Zoledronic acid medac

Adopted Reference Number: EMA/CHMP/271157/2012