Evropa Lek Pharma d.o.o., as a marketing authorization holder for a medicine Lorsilan (lorazepam) 2,5 mg tablets, manufactured by Belupo lijekovi i kozmetika d.d., Croatia, in cooperation with the Institute for medicines and medical devices (CInMED), preventively withdraws the following batches of mentioned medicine from the market:
- batch no 27964061 (expiry date 10/2023 )
- batch no 28624101 (expiry date 08/2024)
- batch no 21339112 (expiry date 11/2025).
- batch no 20804092 (expiry date 08/2025)
- batch no 29717032 (expiry date 02/2025)
- batch no 26824011 (expiry date10/2023)
Withdrawal is carried out for preventive reasons, up to the level of wholesalers and pharmacies. Mentioned batches are being withdrawn based on suspected quality defect, which refers to the change in the appearance of tablets in certain packagings of the medicine that was noticed during the stability test in long-term conditions. No potential safety risks associated with the abovementioned defect have been identified. Healthcare professionals and patients in Montenegro have not reported suspected quality defect of Lorsilan 2.5 mg tablets to the Institute for Medicines and Medical Devices.
Patients in Montenegro have access to a medicine from another manufacturer, which contains the same active substance lorazepam.
We advise all patients using the medicine in question to consult their doctor regarding the continuation of therapy.
