JusticeItaly Official institution
Italy cancels marketing approval for Dimetilfumarato Sandoz at company's request
Italy's medicines agency AIFA has published a notice cancelling the marketing authorization for the human medicine Dimetilfumarato Sandoz, reference 26A05655. The cancellation was requested by the license holder, who gave up the authorization voluntarily. The excerpt does not say when the cancellation takes effect or why it was requested.
What does it mean?
Dimetilfumarato Sandoz is a medicine that could be sold in Italy under an official approval, and that approval is now being cancelled. Anyone who buys or relies on this medicine should check with a pharmacist or doctor about alternatives.
Who is affected?
Patients who use Dimetilfumarato Sandoz, and pharmacies and doctors who supply or prescribe it in Italy.