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, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
