Quality defect report to Soliris 300 mg concentrate for solution for infusion
12.03.2014
Alexion Pharma International has informed the Agency for Medicinal Products and Medical Devices (HALMED) of the quality defect of two batches of Soliris 300 mg concentrate for solution for infusion (eculizumab) of the marketing authorisation holder Alexion Europe SAS-France. The report refers to the batch No 00009 and No 00016, where in the Republic of Croatia only the batch No 00016 is distributed.
The reported defect has been discovered during an on-going appearance testing within the reinforced 15 months stability monitoring where visible particles in approved storage conditions (2-8°C) were observed. The medicinal product is indicated for use in rare diseases: paroxysmal nocturne haemoglobinuria (PHN) and typical haemolytic-uremic syndrome (aHUS) andin the RC is used in small number of patients.
The wholesaler distributing this medicine in the RC obliges to inform the healthcare setting where the product is distributed. The affected batch is not available on the Croatian market any more. There are other batches of this medicine on the Croatian market not affected with the above mentioned quality defect (00021C and 00024C).
HALMED has not received any suspected adverse reaction report to Soliris 300 mg concentrate for solution for infusion.
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.
