Imuldosa
GIF decision: Withdrawal from market, Marketing prohibition
What does this decision mean?
- • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
- • Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.
Non-compliances identified at the manufacturer, including deficiencies in assessment of packaging quality, contamination control and aseptic techniques, may affect key quality parameters, including the sterility of the medicinal product. Potential effects: infections, lack of therapeutic efficacy, serious adverse reactions.
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