EMA Flags Schizophrenia Drug Paliperidone Shortage in EU States Over Pharmathen Manufacturing Issues
Bengaluru: The European Medicines Agency on Thursday disclosed a shortage of an injectable medicine used to treat schizophrenia in some member EU states due to issues at contract manufacturer Pharmathen International.
Paliperidone palmitate, the drug in short supply, is used as a treatment in adults with schizophrenia whose condition has been stabilized with antipsychotic drugs like paliperidone or risperidone.
The shortage affects medicines marketed by Advanz Pharma, Adamed Pharma, Alter, Belupo, Biogaran, EGIS Pharmaceuticals, Elpen, G.L. Pharma and Innovis Pharma, the EMA said.
The shortage could also affect other long-acting injectable medicines containing paliperidone palmitate in additional countries, the regulator added.
The regulator said manufacturing problems at the Greek contract drug manufacturer Pharmathen had caused a shortage, adding the shortage was not linked to product quality defect or safety concern.
Pharmathen did not immediately respond to a Reuters request for comment or details on the issue or how many facilities were affected.
The EMA said there was no known end date for the shortage, and advised healthcare professionals to consider alternative medicines where needed.
The agency said some of its departments are closely monitoring the supply situation and engaging with the companies marketing the drug to mitigate the impact of the supply shortage.
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