Ibandronic Acid Teva
Authorised
This medicine is authorised for use in the European Union
ibandronic acid
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Ibandronic Acid Teva. 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 Teva.
Ibandronic Acid Teva is a medicine that contains the active substance ibandronic acid. It is available as tablets (50 and 150 mg).
Ibandronic Acid Teva is a ‘generic medicine’. This means that Ibandronic Acid Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU). The reference medicines for Ibandronic Acid Teva are Bondronat and Bonviva.
Ibandronic Acid Teva 50 mg is used to prevent ‘skeletal events’ (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Ibandronic Acid Teva 150 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. 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.
The medicine can only be obtained with a prescription.
For the prevention of skeletal events, one 50?mg tablet is taken once a day. The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
For treating osteoporosis, one 150?mg tablet is taken once a month. The tablet must always be taken after an overnight fast, one hour before any food or drink except for water. Patients should also take vitamin D and calcium supplements if they do not get enough from their diet.
Ibandronic Acid Teva must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed. The patient must also not lie down for one hour after taking the tablets.
The active substance in Ibandronic Acid Teva, 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.
Because Ibandronic Acid Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines. Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Ibandronic Acid Teva is a generic medicine and is bioequivalent to the reference medicines, its benefits and risks are taken as being the same as the reference medicines’s.
The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Teva has been shown to have comparable quality and to be bioequivalent 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 Teva be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Teva on 17 September 2010.
For more information about treatment with Ibandronic Acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IB/0022
16/08/2024
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).
Product details
- Name of medicine
- Ibandronic Acid Teva
- Active substance
- ibandronic acid
- International non-proprietary name (INN) or common name
- ibandronic acid
- Therapeutic area (MeSH)
- Breast Neoplasms
- Neoplasm Metastasis
- Fractures, Bone
- Osteoporosis, Postmenopausal
- Anatomical therapeutic chemical (ATC) code
- M05BA06
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic indication
Ibandronic acid 50mg
Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Ibandronic acid 150mg
Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
News on Ibandronic Acid Teva
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