Zoledronic Acid Accord
zoledronic acid
Table of contents
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.
Authorisation details
Product details | |
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Name |
Zoledronic Acid Accord
|
Agency product number |
EMEA/H/C/002667
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Active substance |
zoledronic acid monohydrate
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International non-proprietary name (INN) or common name |
zoledronic acid
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
M05BA08
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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. |
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
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Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
16/01/2014
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Contact address |
Product information
23/09/2020 Zoledronic Acid Accord - EMEA/H/C/002667 - IB/0010
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
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).