Ibandronic Acid Sandoz

What is Ibandronic Acid Sandoz?

Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid. It is available as white tablets (50 mg).

Ibandronic Acid Sandoz is a "generic medicine", meaning that it is similar to a "reference medicine" already authorized in the European Union (EU). The reference medicine for Ibandronic Acid Sandoz is Bondronat.

What is Ibandronic Acid Sandoz used for?

Ibandronic Acid Sandoz is used to prevent "skeletal events" (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases (spread of bone cancer).

The medicine can only be obtained with a prescription.

How is Ibandronic Acid Sandoz used?

The recommended dose is one tablet once a day. The tablets should always be taken after an overnight fast of at least six hours and at least 30 minutes after the first intake of food or drink of the day.

Ibandronic Acid Sandoz should be taken with a glass filled with natural (but not mineral) water in an upright or sitting position; the tablets should not be chewed, sucked or crushed. Furthermore, patients should not lie down in the hour after taking the tablets.

How does Ibandronic Acid Sandoz work?

The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate. It works by blocking the action of osteoclasts, the body's cells responsible for breaking down bone tissue, and thus reducing bone loss. This reduction helps make the bones less prone to breakage, with an advantage in terms of preventing fractures in cancer patients with bone metastases.

How has Ibandronic Acid Sandoz been studied?

Because Ibandronic Acid Sandoz is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine. Bioequivalents are defined as medicinal products that produce the same levels of active ingredient in the body.

What are the benefits and risks of Ibandronic Acid Sandoz?

Because Ibandronic Acid Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.

Why has Ibandronic Acid Sandoz been approved?

The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Ibandronic Acid Sandoz has been shown to have comparable quality and to be bioequivalent to Bondronat. Therefore, the CHMP considered that, as in the case of Bondronat, the benefits outweigh the identified risks. The committee recommended the granting of the marketing authorization for Ibandronic Acid Sandoz.

More information on Ibandronic Acid Sandoz

On 26 July 2011, the European Commission issued a marketing authorization for Ibandronic Acid Sandoz to SANDOZ PHARMACEUTICALS GMBH, valid throughout the EU. The marketing authorization is valid for five years, after which it can be renewed.

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

The full EPAR of the reference medicine is also found on the Agency's website.

Last update of this summary: 03-2011.