Zoledronic Acid Hospira
Authorised
This medicine is authorised for use in the European Union
zoledronic acid
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Zoledronic Acid Hospira. 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 Zoledronic Acid Hospira.
Zoledronic Acid Hospira is a medicine that contains the active substance zoledronic acid. It is available as a concentrate (4 mg/5 ml) to be made up into a solution for infusion (drip) into a vein, and as solutions for infusion (4 mg/100 ml and 5 mg/100 ml).
Zoledronic Acid Hospira is a ‘generic’ and a ‘hybrid’ medicine. This means that it is similar to one or more ‘reference medicines’ already authorised in the European Union (EU). The reference medicine for the 4 mg/5 ml concentrate and 4 mg/100 ml solution is Zometa. Aclasta is the reference medicine for the 5 mg/100 ml solution.
Zoledronic Acid Hospira 4 mg/5 ml concentrate and 4 mg/100 ml solution are 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). They can also be used to treat the hypercalcaemia caused by tumours.
Zoledronic Acid Hospira 5 mg/100 ml solution is used to treat Paget’s disease of the bone in adults. This is a long-term disease where the normal process of bone growth is altered, which causes bones to become weakened or deformed.
The medicine can only be obtained with a prescription.
For the prevention of bone complications and treatment of hypercalcaemia caused by tumours, the usual dose of Zoledronic Acid Hospira 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.
For the treatment of Paget’s disease of the bone, Zoledronic Acid Hospira is given as one infusion lasting at least 15 minutes. An additional infusion, given at least one year after the first one, can be considered if the patient’s disease comes back. Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium. See the package leaflet for full details.
The active substance in Zoledronic Acid Hospira, 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 disease activity in Paget’s disease. 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 Hospira also helps to reduce the amount of calcium released into the blood.
The company provided data from the published literature on zoledronic acid. No additional studies were needed as Zoledronic Acid Hospira is given by infusion and contains the same active substance as the reference medicines, Zometa and Aclasta.
Because Zoledronic Acid Hospira is given by infusion and contains the same active substance as the reference medicines, its benefits and risks are taken as being the same as the reference medicines’.
The CHMP concluded that, in accordance with EU requirements, Zoledronic Acid Hospira has been shown to be comparable to Zometa and Aclasta. Therefore, the CHMP’s view was that, as for Zometa and Aclasta, the benefit outweighs the identified risks. The Committee recommended that Zoledronic Acid Hospira be given marketing authorisation.
A risk management plan has been developed to ensure that Zoledronic Acid Hospira 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 Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic Acid Hospira on 19 November 2012.
For more information about treatment with Zoledronic Acid Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: N/0045
01/10/2021
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
- Zoledronic Acid Hospira
- Active substance
- zoledronic acid monohydrate
- International non-proprietary name (INN) or common name
- zoledronic acid
- Therapeutic area (MeSH)
- Hypercalcemia
- Anatomical therapeutic chemical (ATC) code
- M05BA08
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic indication
4 mg / 5 ml and 4 mg / 100 ml:
- 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).
5 mg / 100 ml:
Treatment of osteoporosis:
- in post-menopausal women;
- in men;
at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:
- in post-menopausal women;
- in men;
at increased risk of fracture.
Treatment of Paget's disease of the bone in adults.
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