Lorafen

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.

An out-of-specification result was found in long-term stability testing (parameter: active substance release below the lower acceptance limit), which constitutes a real and direct threat to patients' health or life. Potential effects: reduced treatment efficacy, disease exacerbation, complications endangering health or life.

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