News and Educations

Information about the recall of Soliris 300 mg concentrate for solution for infusion


The Agency for Medicinal Products and Medical Devices (HALMED) has received via rapid alert system from the Italian Medicines Agency the information that Alexion Europe SAS-France, the marketing authorisation holder for Soliris 300 mg concentrate for solution for infusion (eculizumab), has started a preventive recall procedure of certain batches of this medicinal product.

The investigation results of the previously reported quality defects of this medicine, that HALMED reported on its webpages on 12 March 2014, revealed that a possible cause of these defects could have been so-called Pall manufacturing component for assembling and mixing of the product. Therefore, this manufacturing component has been replaced in further production by a stainless container. Following the investigation results, the marketing authorisation holder decided to recall from precautious reasons all the batches previously manufactured by using the Pall manufacturing component.

A recall procedure is being currently carried out from the healthcare settings in the Republic of Croatia where batches No 00017D, 00021C, 00023C,00024C and 12SOL2D, manufactured by using the Pall component, have been distributed.

There are other batches of Soliris 300 mg concentrate for solution for infusion available on the Croatian market, that are not manufactured as described above and not affected by this recall. Taking account that this medicine is not used in a large number of patients, the quantities of this medicine is ordered according to the current needs.

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.