Zoledronic Acid Accord

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zoledronic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

 

Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone. This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood). Zoledronic Acid Accord can also be used to treat hypercalcaemia caused by tumours.

Zoledronic Acid Accord contains the active substance zoledronic acid and is a ‘generic medicine’. This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Zometa.

This EPAR was last updated on 15/04/2019

Authorisation details

Product details
Name
Zoledronic Acid Accord
Agency product number
EMEA/H/C/002667
Active substance
zoledronic acid monohydrate
International non-proprietary name (INN) or common name
zoledronic acid
Therapeutic area (MeSH)
  • Hypercalcemia
  • Fractures, Bone
  • Cancer
Anatomical therapeutic chemical (ATC) code
M05BA08
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
16/01/2014
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

19/03/2019 Zoledronic Acid Accord - EMEA/H/C/002667 - IAin/0008/G

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Pharmacotherapeutic group

Bisphosphonates

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).

Assessment history

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