Notice about returning of the batch 557867 of Esmeron 10 mg/ml solution for injection to the market
Following to the Information on temporary interruption in distribution and use of the batch 557867 of Esmeron 10 mg/ml solution for injection, published on 9 May 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is hereby informing about the returning of this batch to the market.
The temporary interruption procedure of distribution and use of the one batch this medicine was initiated as a caution assumption, due to a suspected quality defect after an adverse reaction was reported to HALMED by a healthcare professional.
Based on the investigation and the special quality control, the results have shown that the tested samples comply to the specification parameters tested. Taking account of the quality control results, the temporary interruption of distribution and use of the batch 557867 of this medicine is being abolished and the existing stocks may be dispensed and used again.
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.