EU Reports Supply Disruption of Schizophrenia Injection
The European Medicines Agency has flagged a shortage of the schizophrenia drug paliperidone palmitate due to manufacturing problems at Pharmathen.
The European Medicines Agency (EMA) has disclosed a supply shortage of an injectable schizophrenia medication in several European Union member states. The disruption stems from manufacturing issues at Pharmathen International, a Greek contract drug manufacturer.
The affected medicine, paliperidone palmitate, is used to treat adults with schizophrenia whose condition has been stabilized with antipsychotic drugs such as paliperidone or risperidone. The EMA said the shortage impacts products marketed by Advanz Pharma, Adamed Pharma, Alter, Belupo, Biogaran, EGIS Pharmaceuticals, Elpen, G.L. Pharma, and Innovis Pharma.
The regulator warned that other long-acting injectable medicines containing paliperidone palmitate could also face supply constraints in additional countries. It clarified that the shortage is not linked to any product quality defect or safety concern.
Pharmathen has not yet responded to requests for comment on the issue or the number of facilities affected. The EMA stated there is no known end date for the shortage and has advised healthcare professionals to consider alternative medicines where necessary. The agency's departments are closely monitoring the situation and engaging with marketing companies to mitigate the impact.