Zoledronic Acid Noridem

GIF decision: Marketing suspension

What does this decision mean?

• Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.

The tested sample of Zoledronic Acid Noridem 4 mg/5 ml, concentrate for solution for infusion, failed appearance requirements due to the presence of particles visible to the naked eye in the solution. Potencjalne skutki: thromboembolic complications, vascular damage, lack of safety of intravenous therapy.

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