The Main Pharmaceutical Inspector informed about the withdrawal from the market of Fayton (Acidum zoledronicum), which prevents bone complications in adults suffering from bone metastases. The drug does not meet the quality requirements.
The Main Pharmaceutical Inspector decided to withdraw from the market two batches of the drug Fayton (Acidum zoledronicum), 4 mg / 5 ml, concentrate for solution for infusion, 1 vial 5 million:
batch number: PQo776, expiry date: 04.2020
batch number: PP1440, expiry date: 08.2019.
Marketing authorization holder Glenmark Pharmaceuticals sro The decision was made immediately enforceable.
The reason for withdrawing the above-mentioned series from the market is the lack of meeting the quality requirements.
The active substance in Fayton is zoledronic acid, which belongs to a group of medicines called bisphosphonates. Zoledronic acid works by attaching to bone and delaying the rate of bone remodeling. It is used to prevent bone complications such as fractures in adult patients with cancer to the bone (the spread of the cancer from its original site to the bone) and to lower the levels of calcium in the blood of adult patients when calcium levels are too low. too high due to the presence of a tumor.