Lorafen

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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

The confirmed non-compliance in the release of the active substance affects product quality and does not exclude an impact on efficacy and safety of use, nor the risk to human health or life. Potencjalne skutki: lack of efficacy, symptom worsening, complications, risk to health or life.

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