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
|
Active substance |
zoledronic acid monohydrate
|
International non-proprietary name (INN) or common name |
zoledronic acid
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
M05BA08
|
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.
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
16/01/2014
|
Contact address |
Accord Healthcare S.L.U. |
Product information
24/01/2022 Zoledronic Acid Accord - EMEA/H/C/002667 - IA/0012
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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).