The Chief Pharmaceutical Inspector decided to withdraw the series of Egoropal from the market. The reason is the test results which showed that the drug does not meet the quality requirements. The decision is immediately enforceable.
The Chief Pharmaceutical Inspector (GIF) announced the withdrawal of the medicinal product from the market throughout the country:
– Egoropal, Paliperidonum, 75 mg, prolonged-release suspension for injection in pre-filled syringe, pack of 1 pre-filled syringe. 75 mg + 2 needles, GTIN 05995327188706, batch number: 4201475, expiration date: 12/2024.
The responsible entity is the Hungarian company Egis Pharmaceuticals PLC based in Budapest.
GIF also banned the marketing of the above-mentioned product series.
The decision is immediately enforceable.
Reason for drug withdrawal
As a result of the tests and proceedings conducted by GIF, it was determined that the above-mentioned batch of the drug does not meet the quality requirements regarding the “particle size analysis” parameter. In the case of the remaining series, non-compliance with the requirements was excluded.
“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,” we read in the justification of the decision.
Egoropal is an antipsychotic drug used for the maintenance treatment of schizophrenia symptoms in adult patients stabilized on paliperidone or risperidone. The medicinal product helps alleviate the symptoms of the disease and prevents their recurrence.
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