Notice on quality defect of Enbrel 25 mg powder and solvent for solution for injection
08.10.2014
Pfizer Croatia d.o.o., the marketing authorisation’s holder representative in the Republic of Croatia for Enbrel 25 mg powder and solvent for solution for injection, has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of the batches H58480 and H76658 of this medicine.
Namely, it has been 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.
The marketing authorisation holder’s representative has requested wholesalers to stop distributing these batches of the medicine and will send a notification on the discovered quality defect alongside the incorrect package leaflet.
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.
