The aim of this measure is to keep every available pack for Bulgarian patients
The Minister of Health has issued an order banning the export of a medicinal product used for substitution therapy in chronic kidney failure. The measure aims to ensure uninterrupted access to treatment for Bulgarian patients.
The order will remain in effect for six months, until 15 February 2026, and applies to the medicinal product NeoRecormon, with the International Nonproprietary Name (INN) Erythropoietin (Epoetin beta).
The product is an injectable solution in a pre-filled syringe, administered one to three times a week to patients with chronic kidney failure, including those in the terminal stage.
The decision is based on an analysis of available stocks, consumption data, and official notifications from the marketing authorisation holder regarding temporary suspension of sales and delayed deliveries.
The Ministry will notify the order under Directive (EU) 2015/1535 and, if necessary, will use the urgent procedure to ensure its immediate application.
The purpose of this measure is to keep every available package in the country so that Bulgarian patients’ treatment is not interrupted.
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