Information about the recall of two batches of the medicinal product BiCNU injection 100 mg (carmustinum)
Agency for medicinal products and medical devices has received from the importer company, PharmaSwiss, d.o.o. , the information about the recall of two batches of the medicinal product BiCNU (carmustine for injection). The recall of batches 0L60782 and 1C00679 is carried out as a precautious measure due to a quality defect discovered during the product stability testing. Test results demonstrated a higher content of the drug substance with regard to quality requirements, due to an over excessive content of the drug product in a single vial.
The medicinal product BiCNU (carmustine for injection) has no marketing authorisation for the Croatian market and therefore it is imported via a legal exemption scheme for treatment of patients in health care settings.
The recall from the market is being carried out by the importer based on the information from the Bristol Myers Squibb Company, the marketing authorisation holder abroad.
The PharmaSwiss d.o.o. Company has informed all the wholesalers in Croatia about the recall. More so, all the hospitals who received the aforementioned batches have also been informed.
In the Republic of Croatia, new batches of the medicinal product BiCNU injection 100 mg have been imported, who were manufactured at another site and therefore are not subject to recall. Therefore, a substitute batch is available to hospitals, so that patients will not remain without their therapy.
BiCNU is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
- Brain tumours - glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma and metastatic brain tumours.
- Multiple myeloma - in combination with prednisone.
- Hodgkin’s Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
- Non - Hodgkin’s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
HALMED has not received any report to suspect in quality defect or adverse reaction to BiCNU injection 100 mg, however, it will continue to monitor the safe use of the product.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.