Why is Fonzylane not available in our country?

why the drug Fonzylane is not available in our country

Fonzylane

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Olga Sierpniowska Pharmacist

3 years ago

Fonzylane (active ingredient - buflomedil) does not have a valid marketing authorization in Poland. In February 2012, the European Medicines Agency issued a negative decision regarding the use of this preparation and recommended the suspension of marketing authorisations for this medicine throughout Europe. This was due to the observation that there is a risk of serious neurological and cardiac adverse reactions in patients with buflomedil due to the small difference between the therapeutic dose and the dose, which may harm elderly patients or people with certain medical conditions such as kidney problems. The benefits of this medicine have been defined as limited and do not outweigh the risks.

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Why is Fonzylane not available in our country?

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