Safinamide methanesulfonate was approved by European Medicine Agency (EMA) on Feb 22, 2015. It was developed by Newron and Zambon, then marketed as Xadago® by Zambon in EU.
Safinamide is a unique molecule with a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of the excessive release of glutamate. It is indicated for the treatment of Parkinson's disease (PD).
Xadago® is available as film-coated tablet for oral use, containing Eq. 50 mg/100 mg of free Safinamide. The recommended dose is 50 mg or 100 mg once daily.
Update Date:2015-09-18
Update Date:2015-07-29
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2015-02-24 | First approval | Xadago | Parkinson's disease (PD) | Tablet, Film coated | Eq. 50 mg/100 mg Safinamide | Zambon |
Update Date:2015-10-30
Update Date:2015-10-30
Update Date:2016-02-21