GIF recalls and bans sale of an important drug. “It poses a real and immediate threat to health.”

The medicinal product Egoropal has antipsychotic effects. It is used in the maintenance therapy of adult patients diagnosed with schizophrenia. The drug relieves the symptoms of the disease and reduces the risk of relapses. The Chief Pharmaceutical Inspector informed in a released announcement about the withdrawal of one batch of the indicated preparation from sale. Find out the details of the decision.

Egoropal – details of the withdrawn batch of the drug

In the issued decision, the Chief Pharmaceutical Inspector provided more information about the batch of the drug withdrawn from sale:

Egoropal, Paliperidonum, 75 mg, prolonged-release injection suspension in pre-filled syringe, pack of 1 pre-filled syringe, 75 mg + 2 needles

• GTIN: 05995327188706

• batch number: 4201475

• expiry date: 12/2024

• marketing authorization: 27352

The entity responsible for the production of the drug is Egis Pharmaceuticals PLC based in Budapest (Hungary). The Chief Pharmaceutical Inspector decided not only to withdraw the indicated preparation from sale throughout the country. He also banned its introduction to the market. The decision is immediately enforceable.

Why was Egoropal for schizophrenia withdrawn from sale?

The National Medicines Institute conducted a study of the indicated batch of the drug. Analyzes showed that it does not meet the quality requirements specified in the specification. Irregularities were detected in one of the basic parameters (particle size). Its value was above the upper level of admissibility.

“Due to the higher particle size value found in the tests in relation to the requirements specified in the product specification, the Chief Pharmaceutical Inspector found a real threat to patients' health resulting from the lack of proper quality of the analyzed medicinal product. It should be emphasized that the acceptance criteria for quality specification parameters indicated in the registration documentation of a medicinal product are established based on extensive research on the safety of use of this product. Therefore, any exceeding of these limits must be considered a circumstance constituting a real and direct threat to the health or life of patients,” we read in the announcement of the Chief Pharmaceutical Inspectorate.