Distribution, Manufacturing and Inspection

Notice on quality defect of the batch H55110 of Prevenar 13


Pfizer Croatia d.o.o., the representative of the marketing authorisation holder in the Republic of Croatia for Prevenar 13 has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of the batch H55110 of this medicinal product. It is discovered that the package leaflet for Prevenar 13 in single dose vial (0.5 ml) is inserted in the packaging for Prevenar 13 in single dose pre-filled syringe (0.5 ml). These two package leaflets differ in the title and in the section "How Prevenar 13 appears and package content”. Both vaccines are already ready for use, but when administering the vaccine in single dose vial, the solution should be aspirated into the syringe.

HALMED agrees that the marketing authorisation holder’s representative distributes these batches with accompanying notes intended to wholesalers, healthcare professionals and patients as well as the correct 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.