Zoledronic Acid Accord

zoledronic acid

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This is a summary of the European public assessment report (EPAR) for Zoledronic Acid Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zoledronic Acid Accord.

For practical information about using Zoledronic Acid Accord, patients should read the package leaflet or contact their doctor or pharmacist.

What is Zoledronic Acid Accord and what is it used for?

Zoledronic Acid Accord is a medicine that contains the active substance zoledronic acid. It is 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 the hypercalcaemia caused by tumours.

Zoledronic Acid Accord is a ‘generic medicine’. This means that Zoledronic Acid Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Zometa.

How is Zoledronic Acid Accord used?

Zoledronic Acid Accord can only be obtained with a prescription and must only be prescribed and given by a healthcare professional who has experience in the use of this type of medicine given into a vein. The medicine is available as a concentrate (4mg/5ml) which is made up into a solution for infusion (drip) into a vein.

The usual dose of Zoledronic Acid Accord is one infusion of 4 mg over at least 15 minutes. When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderately reduced kidney function. It is not recommended for patients with severely reduced kidney function.

How does Zoledronic Acid Accord work?

The active substance in Zoledronic Acid Accord, zoledronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.

Patients with tumours can have high levels of calcium in their blood, released from the bones. By preventing the breakdown of bones, Zoledronic Acid Accord also helps to reduce the amount of calcium released into the blood.

How has Zoledronic Acid Accord been studied?

The company provided data from the published literature on zoledronic acid. No additional studies were needed as Zoledronic Acid Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.

What are the benefits and risks of Zoledronic Acid Accord?

Because Zoledronic Acid Accord is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicines’.

Why is Zoledronic Acid Accord approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa. Therefore, the CHMP’s view was that, as for Zometa, the benefit outweighs the identified risk. The Committee recommended that Zoledronic acid Accord be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Zoledronic Acid Accord?

A risk management plan has been developed to ensure that Zoledronic Acid Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic Acid Accord, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Zoledronic Acid Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic Acid Accord on 16 January 2014.

For more information about treatment with Zoledronic Acid Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Zoledronic Acid Accord : EPAR - Summary for the public BG = bălgarski 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public ES = español 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public CS = čeština 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public DA = dansk 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public DE = Deutsch 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public ET = eesti keel 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public EL = elliniká 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public EN = English 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public FR = français 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public IT = italiano 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public LV = latviešu valoda 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public LT = lietuvių kalba 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public HU = magyar 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public MT = Malti 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public NL = Nederlands 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public PL = polski 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public PT = português 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public RO = română 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public SK = slovenčina 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public SL = slovenščina 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public FI = suomi 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public SV = svenska 06/02/2014  
Zoledronic Acid Accord : EPAR - Summary for the public HR = Hrvatski 06/02/2014  

This EPAR was last updated on 22/12/2015 .

Authorisation details

Product details

Product details for Zoledronic Acid Accord
NameZoledronic Acid Accord
Agency product numberEMEA/H/C/002667
Active substance

zoledronic acid monohydrate

International non-proprietary name (INN) or common name

zoledronic acid

Therapeutic area HypercalcemiaCancerFractures, Bone
Anatomical therapeutic chemical (ATC) code M05BA08
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Zoledronic Acid Accord
Marketing-authorisation holder

Accord Healthcare Limited

Revision2
Date of issue of marketing authorisation valid throughout the European Union16/01/2014

Contact address:

Accord Healthcare Limited
Sage House 
319 Pinner Road 
North Harrow 
HA1 4HF 
United Kigndom

Product information

Product information

06/11/2015  Zoledronic Acid Accord -EMEA/H/C/002667 -IB/0002

Name Language First published Last updated
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015
Zoledronic Acid Accord : EPAR - Product Information HR = Hrvatski 06/02/2014 22/12/2015

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  
Zoledronic Acid Accord : EPAR - All Authorised presentations HR = Hrvatski 06/02/2014  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Zoledronic Acid Accord : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 10/03/2015 22/12/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Zoledronic Acid Accord : EPAR - Public assessment report HR = Hrvatski 06/02/2014  
CHMP summary of positive opinion for Zoledronic Acid Accord HR = Hrvatski 22/11/2013  

Authorised

This medicine is approved for use in the European Union

More information on Zoledronic Acid Accord