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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/91027/2015

EMEA/H/C/002638

EPAR summary for the public

Ibandronic acid Accord

ibandronic acid

This is a summary of the European public assessment report (EPAR) for Ibandronic acid Accord. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ibandronic acid Accord.

What is Ibandronic acid Accord?

Ibandronic acid Accord is available as a solution for injection (3 mg) in a pre-filled syringe and as a concentrate (2 mg and 6 mg) to be made up into a solution for infusion (drip) into a vein. It contains the active substance ibandronic acid.

Ibandronic acid Accord is a 'generic medicine'. This means that Ibandronic acid Accord is similar to a 'reference medicine' already authorised in the European Union (EU). The reference medicines for Ibandronic acid Accord are Bondronat and Bonviva. For more information on generic medicines, see the question-and-answer document here.

What is Ibandronic acid Accord used for?

Ibandronic acid Accord solution for injection (3 mg) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks). Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.

Ibandronic acid Accord concentrate for solution for infusion (2 mg and 6 mg) is used to:

•    prevent 'skeletal events' (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);

•    treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.

The medicine can only be obtained with a prescription.

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

How is Ibandronic acid Accord used?

For the prevention of skeletal events or the treatment of hypercalcaemia in cancer patients, Ibandronic acid Accord treatment should only be initiated by a doctor who has experience in the treatment of cancer.

In the prevention of skeletal events in patients with breast cancer and bone metastases, Ibandronic acid Accord is given as a 6 mg infusion lasting at least 15 minutes every three to four weeks. Patients with moderate or severe kidney problems should receive Ibandronic acid Accord infusions at a lower dose over an hour.

In the treatment of tumour-induced hypercalcaemia, Ibandronic acid Accord is given as an infusion of 2 or 4 mg, depending on whether the patient's hypercalcaemia is moderate (below 3 mmol/l) or severe (above 3 mmol/l). This will normally bring the blood calcium level down to normal levels within seven days.

For the treatment of osteoporosis, Ibandronic acid Accord is given as an injection into a vein once every three months. Patients should also take vitamin D and calcium supplements.

How does Ibandronic acid Accord work?

The active substance in Ibandronic acid Accord, ibandronic acid, is a bisphosphonate. It stops the action of 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 and in women with osteoporosis.

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

How has Ibandronic acid Accord been studied?

The company provided data from the published literature on ibandronic acid. No additional studies were needed as Ibandronic acid Accord is a generic medicine that is given by infusion or injection and contains the same active substance as the reference medicines, Bondronat and Bonviva.

What are the benefits and risks of Ibandronic acid Accord?

Because Ibandronic acid Accord is a generic, its benefits and risks are taken as being the same as the reference medicines'.

Why has Ibandronic acid Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Ibandronic acid Accord has been shown to have comparable quality and to be comparable to Bondronat and Bonviva. Therefore, the CHMP's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk. The Committee recommended that Ibandronic acid Accord be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Ibandronic acid Accord?

A risk management plan has been developed to ensure that Ibandronic 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 Ibandronic acid Accord, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Ibandronic acid Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic acid Accord on 19 November 2012.

The full EPAR for Ibandronic 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 Ibandronic acid Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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

This summary was last updated in 02-2015.

Ibandronic acid Accord

EMA/91027/2015

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