Kidofen
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- • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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.
Failure to meet quality requirements: exceeding the specification limit for the parameter "Impurities - each single impurity" in stability studies of batch 01AF1024, which may affect the efficacy and safety of the medicine used in children. Potential effects: possible toxic effects and impaired safety or efficacy of therapy.
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