XADAGO Film-coated tablet Ref.[7625] Active ingredients: Safinamide

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

Product name and form

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.

Qualitative and quantitative composition

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
Crospovidone type A
Magnesium stearate
Silica, colloidal anhydrous

Film-coating:

Hypromellose
Macrogol (6000)
Titanium dioxide (E171)
Iron oxide red (E172)
Mica (E555)

Pack sizes and marketing

PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

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

Drugs

Drug Countries
XADAGO Austria, Australia, Brazil, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States

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