Envil gardło
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- • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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.
Stability and reference-sample testing showed values below the limit for the "ethanol content" parameter, meaning non-compliance with the quality specification and no confirmed efficacy or safety of further use of the batches covered by the decision. Potencjalne skutki: reduced treatment effectiveness and lack of guaranteed safety of use.
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