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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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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 National Medicines Institute found that the product does not meet quality requirements due to incorrect mean content of fluticasone and salmeterol per dose and lack of dose uniformity between containers. Potential effects: lack of treatment efficacy, worsening of asthma or COPD symptoms.

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