Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Zambon S.p.A., Via Lillo del Duca 10, 20091, Bresso (MI) - Italy, Tel: +39 02 665241, Fax: +39 02 66501492, Email: info.zambonspa@zambongroup.com
Xadago 50 mg film-coated tablets.
Xadago 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Xadago 50 mg film-coated tablets: Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength “50” on one side of the tablet. Xadago 100 mg film-coated tablets: Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet. |
Xadago 50 mg film-coated tablets: Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide.
Xadago 100 mg film-coated tablets: Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Safinamide |
Safinamide acts through both dopaminergic and non-dopaminergic mechanisms of action. Safinamide is a highly selective and reversible MAO-B inhibitor causing an increase in extracellular levels of dopamine in the striatum. Safinamide is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as addon therapy to a stable dose of levodopa (L-dopa). |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Hypromellose |
PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets.
Not all pack sizes may be marketed.
Zambon S.p.A., Via Lillo del Duca 10, 20091, Bresso (MI) - Italy, Tel: +39 02 665241, Fax: +39 02 66501492, Email: info.zambonspa@zambongroup.com
Xadago 50 mg film-coated tablets:
EU/1/14/984/001
EU/1/14/984/002
EU/1/14/984/003
EU/1/14/984/004
EU/1/14/984/005
Xadago 100 mg film-coated tablets:
EU/1/14/984/006
EU/1/14/984/007
EU/1/14/984/008
EU/1/14/984/009
EU/1/14/984/010
Date of first authorisation: 24 February 2015
Date of latest renewal: 19 September 2019
| Drug | Countries | |
|---|---|---|
| XADAGO | Austria, Australia, Brazil, Germany, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States |
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