Loperamid APTEO MED

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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.

A stability test showed the active substance content below the lower specification limit, meaning the batch does not meet quality requirements and may not provide the intended therapeutic effect. Potential effects: lack of antidiarrheal efficacy, possible worsening of symptoms and complications of the underlying disease.

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