Unfavourable benefit-risk ratio of the active substance fenspiride based on non-clinical studies; an urgent EU procedure was initiated due to a public health concern. Potential effects: serious adverse reactions, threat to health or life.
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Important Information
Do not use the product; check the batch number and return the medicine to the pharmacy; if used, consult a doctor.
Temporary ban on placing the product on the market and suspension of distribution of all batches; decision given immediate effect; MAH filed for withdrawal; ANSM initiated an urgent EU review procedur...
If you feel unwell after consuming this product, contact your doctor or call the poison control center.
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