Distribution, Manufacturing and Inspection

Notice on continuation of delivery of two Enbrel 25 mg powder and solvent for solution for injection batches


Following to the Notice on quality defect of Enbrel 25 mg powder and solvent for solution for injection, released on 8th October 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the continuation of delivery of batches H58480 and H76658 of this medicine.

Namely, the delivery of these batches has been temporarily discontinued for it wa discovered that the package leaflet for other pharmaceutical form - Enbrel 25 mg solvent for injection in pre-filled syringe is inserted in the packaging for Enbrel 25 mg powder and solvent for solution for injection contains. The main differences between these two package leaflets are in the parts relating to the administration manner and storage condition. The solution for injection in pre-filled syringe is already prepared for use, whereas the powder and solvent for solution for injection needs to be prepared for use by dissolving the powder in solvent.

These batches of the medicine will be continuously delivered and each batch will be accompanied by a notice to healthcare professionals (prescribers) on the incorrect package leaflet in packaging for the Croatian market and a specimen of the correct package leaflet from these batches that will be used when advising patients. Also, when dispensing every package of these batches, it is necessary to attach the current package leaflet (it will be organised by the marketing authorisation holder’s representative), inform patients with this error and advise them about the correct use of the medicine.

We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. 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 their doctor or pharmacist about the continuation of their therapy.