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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/732429/2013

EMEA/H/C/002667

EPAR summary for the public

Zoledronic Acid Accord

Zoledronic acid

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. For more information on generic medicines, see the question-and-answer document here.

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

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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.

The full EPAR for Zoledronic Acid Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Zoledronic Acid Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

Zoledronic Acid Accord

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