Zoledronic acid medac
Authorised
This medicine is authorised for use in the European Union
zoledronic acid
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Zoledronic acid medac. 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 medac.
Zoledronic acid medac is a medicine that contains the active substance zoledronic acid. It is available as a 4mg/100ml solution for infusion (drip into a vein) and as a 4mg/5ml concentrate for solution for infusion.
Zoledronic acid medac is a ‘generic medicine’. This means that Zoledronic acid medac is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Zometa.
Zoledronic acid medac can be 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 medac can also be used to treat the hypercalcaemia caused by tumours.
The medicine can only be obtained with a prescription.
Zoledronic acid medac must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
The usual dose of Zoledronic acid medac 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 bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys. It is not recommended for patients with severe kidney problems.
The active substance in Zoledronic acid medac, 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 medac 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 medac is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Because Zoledronic acid medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid medac has been shown to have comparable quality and to be bioequivalent to Zometa. Therefore, the CHMP’s view was that, as for Zometa, the benefit outweighs the identified risk. The Committee recommended that Zoledronic acid medac be given marketing authorisation.
A risk management plan has been developed to ensure that Zoledronic acid medac 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 medac, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that markets Zoledronic acid medac will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid medac on 03 August 2012.
For more information about treatment with Zoledronic acid medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IB/0030
23/09/2020
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 medac
- Active substance
- zoledronic acid monohydrate
- International non-proprietary name (INN) or common name
- zoledronic acid
- Therapeutic area (MeSH)
- Fractures, Bone
- Cancer
- Anatomical therapeutic chemical (ATC) code
- M05BA08
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic indication
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).
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